Search Results for "Acne and Rosacea"
Nicole D. Cresce BS,a Scott A. Davis MA,a William W. Huang MD MPH,a Steven R. Feldman MD PhDa,b,c| |
PURPOSE: We review available literature to assess the HRQL impact of acne and rosacea and compare them with major medical conditions.
METHODS: A PubMed search identified studies that utilized the Short Form 36 (SF-36), the Dermatology Life Quality Index (DLQI), and the willingness-to-pay (WTP) metric to assess the HRQL impact of acne and rosacea. These data were compared to HRQL values for other diseases.
RESULTS: The HRQL impact of acne is similar to asthma, epilepsy, diabetes, back pain, arthritis, and coronary heart disease using SF-36 data. DLQI scores for acne ranged from 2 to 17.7 and for rosacea ranged from 4.3 to 17.3; the DLQI scores for psoriasis ranged from 1.7 to 18.2. WTP data identified ranged widely for both acne and rosacea.
LIMITATIONS: There was limited broadly generalizable data for acne and rosacea.
CONCLUSIONS: Acne and rosacea impact HRQL to a similar degree as other major medical conditions by indirect comparison to psoriasis, a skin condition causing significant disability, and by direct comparison for acne. In the setting of limited health care resources, allocation should be grounded in the evidence that acne and rosacea are not trivial in their effects.
J Drugs Dermatol. 2014;13(6):692-697.
Penelope J. Kallis BS BA,a Alexandra Price MD,a Jacquelyn R. Dosal MD,a Anna J. Nichols MD PhD,a and Jonette Keri MD PhDa,b| |
Stephanie Diamantis, Heidi A.Waldorf MD| |
Kimberly J. Butterwick MD, Lorren S. Butterwick, Amy Han MD| |
Efficacy of Extended-Release 45 mg Oral Minocycline and Extended-Release 45 mg Oral Minocycline Plus 15% Azelaic Acid in the Treatment of Acne Rosacea
J. Mark Jackson MD,a Douglas J. Lorenz PhD,b and Leon H. Kircik MDc-e| |
J Drugs Dermatol. 2013;12(3):292-298.
Javier Ruiz-Esparza, MD; Julio Manuel Barba Gomez, MD and Ivan Rosales Berber, MD| |
Numerous oral and systemic medications, used singly or in combination, are considered the standard treatment for controlling the disease. Unfortunately, the expense, time, and effort required for its treatment are considerable.
Non-Ablative Radiofrequency (NARF) is a recent technological development that permits the use of intense heat delivered to deep dermal and subcutaneous tissues without a superficial burn.
Thermotherapy is not new in the medical field, as the use of deep heat as treatment for inflammatory conditions has had a long history in medicine. We recently reported on its effectiveness in treating active acne vulgaris1. This new technology was also tried in 3 patients with rosacea, and the preliminary results are the subject of this report.
Boni E. Elewski MD| |
Melvin Lee, John Koo MD| |
Alan B. Fleischer Jr MD| |
Rosacea and acne are chronic inflammatory skin conditions that share an inflammatory pathogenesis, but clinically remain quite distinct. Although many have long assumed that these conditions are primarily infectious, emerging evidence suggests that inflammation plays a critical role in the pathogenesis of these disorders. Part of the innate immune system, the antimicrobial and proinflammatory cathelicidins, may be downregulated by both azelaic acid and subantimicrobial doxycycline. In acne, the creation of papules, pustules and nodules is clearly mediated through immune mechanisms, and the antiinflammatory effects of retinoids play a key role in management. Recent observations help us understand in greater detail the role that inflammation plays in these two diseases, and the mechanisms by which commonly used medications exert their effect by modulating inflammatory processes. This review will present and synthesize recently acquired information as it relates to inflammatory acne and rosacea pathogenesis and clinical management.
J Drugs Dermatol. 2011;10(6):614-620.
April A. Larson MD, Mitchel P. Goldman MD| |
Mark W. Trumbore PhD, Jay A. Goldstein MD, Ronald M.Gurge PhD| |
Del Rosso, J.Q.| |
Jennie B. Nally MD, Diane S. Berson MD| |
Hilary Baldwin MD| |
Topical Treatment With Liposomal Sodium Copper Chlorophyllin Complex in Subjects With Facial Redness and Erythematotelangiectatic Rosacea: Case Studies
David B. Vasily MD| |
J Drugs Dermatol. 2015;14(10):1157-1159.
Alan R. Shalita MD and Whitney P. Bowe MD| |
Sara L. Jensen, MD and RonaBeth Holmes, MD| |
James Q. Del Rosso DO| |
James Q. Del Rosso DO| |
A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Efficacy and Safety of Clindamycin 1.2% and Tretinoin 0.025% Combination Gel for the Treatment of Acne Rosacea Over 12 Weeks
Background: Papulopustular acne rosacea is a chronic inflammatory condition which can be difficult to treat. Many patients are unwilling to use systemic medications, and single topical agents alone may not address all the symptoms of rosacea. A combination topical clindamycin phosphate 1.2% and tretinoin 0.025% gel is efficacious for acne vulgaris, and may be helpful for rosacea, since acne vulgaris and rosacea shares many similar clinical and histologic features.
Objective: To assess the preliminary efficacy and safety of a combination gel consisting of clindamycin phosphate 1.2% and tretinoin 0.025% on papulopustular rosacea after 12 weeks of usage.
Methods: Randomized, double-blind, placebo controlled two site study of 79 participants with moderate to severe papulopustular acne rosacea using both physician and subjects' validated assessment tools. Primary endpoint consisted of statistically significant reduction in absolute papule or pustule count after 12 weeks of usage.
Results: There was no significant difference in papule/pustule count between placebo and treated groups after 12 weeks (P=0.10). However, there was nearly significant improvement in physicians' assessments of the telangiectasia component of rosacea (P=0.06) and erythematotelangiectatic rosacea subtype (P=0.05) in treated versus placebo group after 12 weeks. The only significant adverse event different was facial scaling, which was significantly increased in treated group (P=0.01), but this did not result in discontinuation of study drug.
Conclusions: A combination gel of clindamycin phosphate 1.2% and tretinoin 0.025% may improve the telangiectatic component of rosacea and appears to better treat the erythemotelangiectatic subtype of rosacea rather than papulopustular subtype. Our preliminary study suggests that future studies with much larger sample size might confirm our findings. Clinical Trials: NCT00823901.
J Drugs Dermatol. 2012;11(3):333-339.
Amy Miller MD| |
Linda Stein Gold MD| |
James Q. Del Rosso DO FAOCD, Joseph Bikowski MD| |
Paradoxical Erythema Reaction of Long-term Topical Brimonidine Gel for the Treatment of Facial Erythema of Rosacea
Erin Lowe MSIVa and Scott Lim DOb| |
J Drugs Dermatol. 2016;15(6):763-765.
Brad A. Yentzer MD and Alan B. Fleischer Jr. MD| |
Arisa Ortiz MD, Laila Elkeeb MD, Anne Truitt MD,Rasha Hindiyeh MD, Lisa Aquino MD, Minh Tran,Gerald Weinstein MD| |
Background: Current treatments for acne rosacea are often associated with unsatisfactory outcomes and adverse effects.
Objective: To determine the efficacy and tolerability of a new moisturizing lotion for improving the clinical signs and symptoms of mild-to-moderate acne rosacea.
Methods: In a 12-week, open-label study, a moisturizing lotion containing furfuryl tetrahydropyranyladenine as PRK124 (0.125%, Pyratine-XR™, Senetek PLC, Napa, CA) was applied twice daily to subjects with mild-to-moderate rosacea. Improvement in the appearances of erythema and papules were assessed by the treating physician. Skin barrier function was measured by transepidmal water loss after treatment. Tolerability and cosmetic outcome were evaluated by patients.
Results: Twenty-one participants completed the study. Overall clinical improvement was observed in 80% of subjects, with most showing mild-to-moderate improvement. Erythema, papule counts, and telangiectasia were reduced. The reduction in TEWL was significant at weeks 4 (p = 0.01), 8 (p < 005), and 12 (p<0.001). Rosacea symptoms (burning, stinging, dryness) were progressively reduced, with reduction in dryness achieving statistical significance at weeks 4 (p = 0.035), 8 (p = 0.037) and 12 (p = 0.016). Treatments were well tolerated and cosmetic outcomes were acceptable. Treatment-induced irritation was not observed.
Conclusion: The new moisturizing lotion containing furfuryl tetrahydropyranyladenine as PRK124 shows a continued trend toward improvement of skin barrier function and the appearances of erythema and papules associated with mild-to-moderate rosacea during 12 weeks of treatment.
Evan Darwin BA, Jessica Cervantes BA, and Hadar Lev-Tov MD| |
Managing Rosacea: A Review of the Use of Metronidazole Alone and in Combination with Oral Antibiotics
Jennifer F. Conde BA, Christopher B. Yelverton MD MBA, Rajesh Balkrishnan PhD, Alan B. Fleischer Jr. MD, Steven R. Feldman MD PhD| |
What More Can We Learn About Acne and Rosacea? Just Keep Reading, Questioning, and Searching for Clinical Relevance Beyond the Limitations of Clinical Trials
James Q. Del Rosso DO FAOCD| |
Jerry Tan MDa and Matthew Leoni MD MBAb| |
OBJECTIVE: The objective of this study was to validate the revised patient’s self-assessment (PSA) scale and evaluate it for statistical reliability and validity in quantification of facial erythema of rosacea.
METHODS: The validity of the PSA scale was evaluated by assessing the test-retest reliability, construct validity, and known-groups validity based on the data collected during a Phase 2b study on brimonidine gel for the treatment of persistent facial erythema of rosacea.
RESULTS: Based on the results of this evaluation, this PSA scale demonstrated test-retest reliability, construct validity, and known-groups validity.
LIMITATIONS: Study results are most generalizable to those with moderate to severe erythema.
CONCLUSION: The PSA is an appropriate scale to assess facial erythema associated with rosacea.
J Drugs Dermatol. 2015;14(8):841-844.
Zoe D. Draelos MD| |
A Pilot, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of IncobotulinumtoxinA Injections in the Treatment of Rosacea
Steven H. Dayan MD,a,b,c Nazanin Ashourian PhD,a,b and Katherine Cho MPHa,b| |
BACKGROUND: Rosacea has a variable presentation. Whereas the pathophysiology may differ, erythema, and flushing are the most consistent findings in all patients.
OBJECTIVE: To evaluate the safety and efficacy of incobotulinumtoxinA in reducing the severity of rosacea symptoms.
METHODS: Nine subjects with erythematotelangiectactic or papulopustular rosacea were randomized in 2 groups. Subjects in Group 1 (n=4) received up to a total of 20 U of incobotulinumtoxinA in the affected area (across both cheeks). Subjects in Group 2 (n=5) were injected with equal volumes of a saline solution. Rosacea Clinical Scores and subject satisfaction were evaluated at baseline and at 1, 4, 12, and 16 weeks post-treatment. At week 16, both groups were injected with incobotulinumtoxinA. Follow-up visits were performed at 1 and 4 weeks post-retreatment.
RESULTS: Patients in Group 1 exhibited reduction in the primary features of rosacea within 4 weeks of treatment with incobotulinumtoxinA. Consistent with this observation, patients in Group 2 (who had received the placebo in the first arm without significant changes to their symptoms) exhibited reductions in all of the primary and some of the secondary features upon treatment with incobotulinumtoxinA.
CONCLUSIONS: IncobotulinumtoxinA may be a safe and effective agent to reduce the severity of rosacea symptoms and increase patient satisfaction.
J Drugs Dermatol. 2017;16(6):549-554.
Since being approved by the FDA over a decade ago, azelaic acid (AzA) 15% gel has boasted a long track-record in efficacy and safety in the topical treatment of papulopustular rosacea (PPR), both as monotherapy and in combination with oral therapy. AzA 15% gel markedly reduced both papulopustular lesions and overall facial erythema in pivotal Phase 3 studies.
This supplement gives the latest information on the pharmacologic properties of AzA that correlate with therapeutic action in rosacea; and explores new horizons related to formulation development, such as an oil-in-water emulsion foam of micronized AzA 15% that is proving to be well-tolerated and effective for patients with moderate to severe PPR.
Joseph B. Bikowski, MD; and Mitchel p. Goldman, MD| |
James Q. Del Rosso DO, Hilary Baldwin MD, Guy Webster MD| |
Amy Forman Taub, MD| |
Thirty-two consecutive patients of Fitzpatrick skin types I- III underwent 1 to 7 treatments with intense pulsed light. Patients were assessed clinically and photographically. In addition, patients completed a detailed questionnaire regarding their response to treatment.
Following treatment, eighty-three percent of patients had reduced redness, 75% noted reduced flushing and improved skin texture, and 64% noted fewer acneiform breakouts. Complications were minimal and transitory.
It appears that intense pulsed light is an effective treatment for the signs and symptoms of rosacea and represents a new category of therapeutic options for the rosacea patient.
Steven L. Harlan MD FAAD| |
Objective: To assess patient reported outcomes in patients receiving compounded topical (hydrocortisone 0.75% and precipitated sulfur 0.5%) lotion for up to 15 years for common dermatological conditions of the face.
Methods: In a retrospective study, 300 patients were randomly sampled from the dermatology clinic who had used, or were continuing to use, a lotion based, pharmacy-compounded topical preparation for the face. The topical compound was used in therapies for seborrheic dermatitis and combination with prescription topical therapy for patients with acne and rosacea with tolerability problems.
Results: None of the 300 patients experienced steroid acne, rebound phenomenon, or perioral dermatitis associated with use of hydrocortisone 0.75% and precipitated sulfur 0.5% on the face.
Conclusion: There was no evidence found that perioral dermatitis, steroid acne, or rebound phenomenon occurs when sulfur is compounded with topical hydrocortisone 0.75%.
The Multifunctionality of 10% Sodium Sulfacetamide, 5% Sulfur Emollient Foamin the Treatment of Inflammatory Facial Dermatoses
Zoe Diana Draelos MD| |
Joseph Bikowski MD FAAD| |
Efficacy of a Novel Rosacea Treatment System: An Investigator-Blind, Randomized, Parallel-Group Study
James J. Leyden MD| |
Introduction: A rosacea treatment system (cleanser, metronidazole 0.75% gel, hydrating complexion corrector, and sunscreen SPF30) has been developed to treat rosacea.
Methods: Thirty women with mild or moderate erythema of rosacea on their facial cheeks were randomly assigned to use one of the following for 28 days: the rosacea treatment system (RTS); RTS minus metronidazole (RTS-M); or metronidazole 0.75% gel plus standard skin care (standard cleanser and standard moisturizer/sunscreen) (M+SSC).
Results: At day 28, global improvement was evident in 90 percent of patients using RTS, 60 percent using RTS-M, and 67 percent using M+SSC. Erythema was significantly lower with RTS from day 14 onward, and unchanged with M+SSC. The proportion of patients reporting their skin was easily irritated at least sometimes was 40 percent with RTS, 70 percent with RTS-M, and 89 percent with M+SSC.
Conclusion: The rosacea treatment system may offer superior efficacy and tolerability to metronidazole plus the standard skin care used in this study.
J Drugs Dermatol. 2011;10(10):1179-1185.
Efficacy and Tolerability of a Cosmetic Skin Care Product With Trans-4-t-butylcyclohexanol and Licochalcone A in Subjects With Sensitive Skin Prone to Redness and Rosacea
Zorica Jovanovic PhD,a Nariman Angabini MD,b Sonja Ehlen MD,c Zrinka Bukvic Mokos MD,d Milica Subotic MD,e and Gitta Neufang PhDa| |
BACKGROUND: Sensitive skin and rosacea are skin conditions, which may affect the quality of life of the patients considerably. In vitro and in vivo data indicated that the combination of trans-t-butylcyclohexanol and licochalcone A is an effective combination for alleviating the increased sensitivity of rosacea subtype I.
OBJECTIVE: Objective of this open dermocosmetic study was to investigate the efficacy and tolerability of a skin care product containing the anti-inflammatory licochalcone A and the TRPV1 antagonist trans-t-butylcyclohexanol in subjects with sensitive skin prone to redness and rosacea.
METHODS: 1221 subjects with sensitive skin and rosacea stage 0-II applied the test product twice daily for 4 weeks. Clinical assessment of sensitive skin and rosacea symptoms were performed at baseline and after 4 weeks. Additionally, at treatment end the test subjects filled a self-assessment questionnaire.
RESULTS: After 4 weeks of application, both, clinical and subjective assessment have shown improvement of all symptoms of sensitive skin and rosacea in a significant number of subjects (P less than 0.001). The test product was efficacious and very well tolerated also when used in conjunction with pharmacological treatments of the skin condition under scrutiny.
Conclusions: The study confirmed the good tolerability and efficacy of the skin care product in the management of sensitive skin prone to redness and rosacea when used alone or in combination with other therapies.
J Drugs Dermatol. 2017;16(6):605-611.
Lissy Hu BA,a Christina Alexander BA,b Nicole F. Velez MD,c F. Clarissa Yang MD,c
Alvaro Laga Canales MD MMSc,c,d Stephanie Liu MD,c and Ruth Ann Vleugels MD MPHc,
J Drugs Dermatol. 2015;14(6):628-630.
Michael Romanowicz DMD RPh, Judith J Stephenson SM, James Q. Del Rosso DO, Greg Lenhart MS| |
Update on the Management of Rosacea: A Status Report on the Current Role and New Horizons With Topical Azelaic Acid
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2014;13(suppl 12):s101-s107.
Jessica Wu MD| |
Rosacea Fulminans With Extrafacial Lesions in an Elderly Man: Successful Treatment With Subantimicrobial-Dose Doxycycline
Lauren A. Smith MD, Shane A. Meehan MD, and David E. Cohen MD MPH| |
J Drugs Dermatol. 2014;13(6):763-765.
Combined Effect of Anti-inflammatory Dose Doxycycline (40-mg Doxycycline, USP Monohydrate Controlled-Release Capsules) and Metronidazole Topical Gel 1% in the Treatment of Rosacea
Joseph F. Fowler Jr. MD| |
Tracy M. Campbell MD, Rachel Neems BS, Julie Moore MD| |
The Face and Mind Evaluation Study: An Examination of the Efficacy of Rosacea Treatment Using Physician Ratings and Patients’ Self-Reported Quality of Life
Alan Fleischer MD, Suephy Chen MD| |
Design: Longitudinal, open-label, observational study.
Patients: 583 patients with mild to moderate rosacea participated in this study.
Interventions: Patients received azelaic acid gel either alone or in combination with other standard treatment for rosacea according to each participating physician’s standards of care. Main Outcome Measures: Change in Investigator’s Global Assessment score, measuring the severity of rosacea symptoms, from baseline to follow-up, and change in scores on the RosaQoL?, a rosacea-related quality-of-life instrument with 4 component measures (Overall, Emotion, Symptom, and Function) completed by patients at both baseline and follow-up.
Results: Over the course of treatment, the mean Investigator’s Global Assessment score dropped from 3.52 to 2.10 (P < .0001). Patients who were prescribed combination therapy had significantly greater improvement than those who were prescribed azelaic acid gel alone (P < .0001). All 4 components of the RosaQoL? also showed significant improvement over the course of treatment, regardless of the type of therapy prescribed (P < .0001).
Conclusion: Azelaic acid gel, either alone or in combination with other medications, is efficacious in the treatment of mild to moderate rosacea, as shown by observational data collected in the clinical setting from both treating physicians and patients.
Rosacea is a common disorder that is both under recognized and undertreated. Prevalence figures indicate that it may be present in 1 of every 10 adults in a primary care waiting room. Untreated, patients with rosacea can suffer significant emotional, workplace, and social impairments. While rosacea has been recognized since ancient times, only recently have investigators begun to identify the pathophysiologic elements responsible for the characteristic erythema, flushing, dysesthesias, and papulopustular manifestations of the disease. Although the etiology of rosacea is unclear, inflammation appears to be a central element. Experimental evidence suggests that abnormalities of the skin's innate and adaptive immune responses may play pivotal roles. Once recognized, effective topical and systemic therapies can be prescribed to lessen the impact of the disease on the patient's life. Although initially administered in an empiric fashion, it now seems clear that the role of antibiotics in patients with rosacea depends upon their anti-inflammatory rather than their antimicrobial properties. Consequently, practitioners have the opportunity to practice good antibiotic stewardship when treating the disease, particularly with systemic therapies. Therapy with subantimicrobial dosing and with topical treatments can modulate the inflammation of rosacea without exerting antibiotic pressure responsible for the emergence of antibiotic resistance.
J Drugs Dermatol.2012;11(6):725-730.
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel for Rosacea: Summary of a Placebo-Controlled, Double-Blind Trial
J Drugs Dermatol. 2012;11(12):1410-1414.
James Q. Del Rosso DO FAOCD| |
Julie Harper MD,a James Q. Del Rosso DO,b Ilia L. Ferrusi PhDc| |
Long-Term Safety and Efficacy of Once-Daily Topical Brimonidine Tartrate Gel 0.5% for the Treatment of Moderate to Severe Facial Erythema of Rosacea: Results of a 1-Year Open-Label Study
Angela Moore MD,a Steven Kempers MD,b George Murakawa MD,c Jonathan Weiss MD,d Amanda Tauscher MD,e Leonard Swinyer MD,f Hong Liu MSc,g and Matthew Leoni MDg on behalf of the Brimonidine LTS Study Group| |
J Drugs Dermatol. 2014;13(1):56-61.
Randomized, Phase 2, Dose-Ranging Study in the Treatment of Rosacea With Encapsulated Benzoyl Peroxide Gel
James J. Leyden MD| |
DESIGN: Multi-centered randomized, double blind, vehicle controlled parallel group, 12 week treatment in 92 patients with papulopustular rosacea. Primary endpoints were dichotomized IGA with success defined as clear/near clear and reduction in inflammatory lesions.
PATIENTS: 92 patients: 74% graded as moderate IGA, 14% severe and 12% mild. The mean inflammatory lesion count was 24.
INTERVENTION: Once daily treatment for 12 weeks with vehicle, 1% or 5% E-BPO.
RESULTS: 1% and 5% E-BPO were superior to vehicle in reducing papulopustular lesions P=0.01 and P=0.02. 5% E-BPO was superior to vehicle for IGA P=0.0013.
J Drugs Dermatol. 2014;13(6):685-688.
Diane Thiboutot MD| |
Why Is Rosacea Considered to Be an Inflammatory Disorder?
The Primary Role, Clinical Relevance, and Therapeutic Correlations of Abnormal Innate Immune Response in Rosacea-Prone Skin
The pathophysiology of rosacea has undergone renewed interest over the past decade, with a large body of evidence supporting the role of an abnormal innate immune response in rosacea. Many mechanisms interact with the cutaneous innate immune system that may be operative. A variety of potential triggers stimulate this immune detection system which is upregulated and hyper-responsive in facial skin of patients with rosacea as compared to normal skin. Based on the most current data, two conclusions have been reached. First, the major presentations of rosacea appear to be inflammatory dermatoses. Second, the presence of a microbial organism is not a primary or mandatory component of the pathogenesis of rosacea. Available therapies for rosacea exhibit reported modes of action that appear to correlate with the inhibition of inflammatory processes involved in the pathophysiology of at least some presentations of rosacea.
J Drugs Dermatol.2012;11(6):694-700.
Emil A. Tanghetti MD,1 J. Mark Jackson MD,2 Kevin Tate Belasco DO MS,3 Amanda Friedrichs MD,4 Firas Hougier MD,5 Sandra Marchese Johnson MD,6 Francisco A. Kerdel MD,7 Dimitry Palceski DO FAOCD,8 H. Chih-ho Hong MD FRCPC,9 Anna Hinek MD MSc FRCPC,10 Maria Jose Rueda Cadena MD11| |
J Drugs Dermatol. 2015;14(1):33-40.
Neal Bhatia MD| |
Gita Faghihi MD,a Parastoo Khosravani MD,a Mohammad Ali Nilforoushzadeh MD,a,b Sayyed Mohsen
Hosseini PhD,a Fatemeh Assaf MD,a Naser Zeinali MD,a and Abbas Smiley MD MScc
METHODS: In a double-blind randomized clinical trial, 56 adult patients with papulopustular rosacea were enrolled. The severity of disorder was determined by the patient according to visual analogue score (VAS). Investigator’s global assessment (IGA) scores and number of inflammatory lesions were recorded. 5% dapsone gel was administered for group D and 0.75% metronidazole gel was administered for group M. Systemic doxycycline was administered for all patients. Follow-up assessments were done at 4, 8, and 12 weeks. Changes in VAS, IGA scores and number of lesions were evaluated. Intention to treat analysis was carried out using SPSS version 17 (Chicago, IL).
RESULTS: There was no significant difference in sex and age distribution between the two groups. Mean (SD) IGA score before and after intervention in group D was 3.9 (0.9) and 3.3 (0.9), respectively (P<0.0001). Mean (SD) IGA score before and after intervention in group M was 4.2 (1.2) and 3.6 (1.3), respectively (P<0.0001). Mean (SD) number of lesions before and after intervention in group D was 15 (7.4) and 11.1 (6), respectively (P<0.0001). Mean (SD) number of lesions before and after intervention in group M was 17.6 (7.7) and 12.5 (7.4), respectively (P<0.0001). Mean (SD) VAS score before and after intervention in group D was 6.6 (1.8) and 5.7 (1.9), respectively (P<0.0001). Mean (SD) VAS score before and after intervention in group M was 6.9 (2.0) and 5.3 (2.1), respectively (P<0.0001). Mean IGA score, mean number of lesions and mean VAS score were not significantly different between the two groups, whether before, during or after intervention.
CONCLUSION: Dapsone gel was as effective as metronidazole gel in the treatment of papulopustular rosacea.
J Drugs Dermatol. 2015;14(6):602-606.
Steven H. Dayan MD,a Rachel N. Pritzker MD,b and John P. Arkins BSc
aClinical Assistant Professor, University of Illinios Department of Otolaryngology, Chicago, IL bDepartment of Medicine, Division of Dermatology, John H.Stroger Jr. Hospital of Cook Country, Chicago, IL cDeNova Research, Chicago, IL
J Drugs Dermatol. 2012;11(12):e76-e79.
Aditya K Gupta MD PhD FRCP(C), Karyn Nicol HBMSc| |
Clinically Relevant Reduction in Persistent Facial Erythema of Rosacea on the First Day of Treatment With Oxymetazoline Cream 1.0%
Emil A. Tanghetti MD,a Jeffrey S. Dover MD FRCPC,b David J. Goldberg MD,c Sunil S. Dhawan MD,d Lei Luo MPH,e David R. Berk MD,e Gurpreet Ahluwalia PhD,e and Nancy Alvandi PhDe| |
Linda F. Stein Gold MD| |
J Drugs Dermatol. 2013;12(suppl 6):s67-s69.
Peter W. Hashim MD MHS,a Tinley Chen BA,a Julie C. Harper MD,b and Leon H. Kircik MDa,c,d| |
J. Mark Jackson MDa and Michelle Pelle MDb| |
Many topical medications are available for the treatment of papulopustular rosacea. While treatments contain metronidazole, azelaic acid, or sodium sulfacetamide-sulfur as the active ingredient, the composition of the vehicle formulations varies widely. These vehicles come in gels, creams, lotions and foams; some ingredients are common to many vehicles, while some vehicles contain unique ingredients designed to optimize skin penetration and delivery of the active drug to its target. Vehicles can also influence tolerability, which is always a concern in patients with heightened skin sensitivity, and compliance, which is typically lower for topical treatments than oral treatments. Ideally, the vehicle of any rosacea treatment should enhance drug delivery, be nonirritating and be easy to use. Ingredients that help repair barrier function are also desirable. This review will focus on the key components of the vehicles from the most commonly used topical therapies for papulopustular rosacea and how vehicle formulations influence the delivery of active ingredient, skin barrier repair, tolerability and compliance.
J Drugs Dermatol. 2011;10(6):627-633.
Arielle R. Nagler| |
Brad A. Yentzer MD, Richard W. McClain BS, Steven R. Feldman MD PhD| |
Purpose: To review the available data from clinical trials for evidence of initial worsening of acne with topical retinoids.
Methods: A PubMed and Google Internet search was performed for sources indicating or refuting worsening of acne with topical retinoids.
Results: No primary data from clinical trials were identified to support the dogma of acne worsening secondary to topical retinoids. Available data point to topical retinoids improving acne, even during the first couple weeks of treatment.
Conclusion: It is unlikely that acne worsens or "flares" due to the initiation of topical retinoids. Some acne patients may have worsening of acne during the first week or two as part of the natural disease process.
Uwe Wollina MD, Gesina Hansel Dipl.-Med, Andre Koch MD, Erich Köstler MD| |
Pivotal Trial of the Efficacy and Safety of Oxymetazoline Cream 1.0% for the Treatment of Persistent Facial Erythema Associated With Rosacea: Findings from the Second REVEAL Trial
Leslie Baumann MD,a David J. Goldberg MD,b Linda Stein Gold MD,c Emil A. Tanghetti MD,d Edward Lain MD,e Joely Kaufman MD,f Emily Weng ScD MBA,g David R. Berk MD,g and Gurpreet Ahluwalia PhDg| |
J Drugs Dermatol. 2018;17(3):290-298.
Clinical Effects of a Novel Topical Composition on Persistent Redness Observed in Patients Who Had Been Successfully Treated With Topical or Oral Therapy for Papulopustular Rosacea
Hilary Baldwin MD,a Diane Berson MD,b Maria Vitale MS,c Margarita Yatskayer MS,c
Nannan Chen PhD,c and Christian Oresajo MD PhDc,d
J Drugs Dermatol. 2014;13(3):326-331.
Todd E. Schlesinger MD FAADa and Callie Rowland Powell BSN RNb| |
DESIGN and SETTING: Prospective, observational, non-blinded efficacy and tolerability study in an outpatient setting.
PARTICIPANTS: Individuals 18 to 75 years of age with mild to moderate facial rosacea.
MEASUREMENTS: Outcome measures included papules, pustules, erythema, edema, telangiectasia, burning or stinging, dryness and provider global assessment (PGA), which were all measured on a five-point scale. Subjects were assessed at baseline, week 2, week 4, and week 8.
RESULTS: Final data for 14 of 15 subjects are presented. Through visual grading assessments, hyaluronic acid sodium salt cream 0.2% was shown to improve the provider global assessment by 47.5 percent from baseline to week 4. Reductions in papules, erythema, burning or stinging, and dryness were 47, 51.7, 65, and 78.8 percent, respectively at week 4. At week 8, the provider global assessment was improved from baseline in 78.5 percent of subjects.
CONCLUSION: Improvement was noted in measured clinical parameters with use of topical low molecular weight hyaluronic acid. Topical low molecular weight hyaluronic acid is another option that may be considered for the treatment of rosacea in the adult population. Compliance and tolerance were excellent. Consideration should be given to use for individuals with rosacea characterized by an erythematous and/or papular component.
J Drugs Dermatol. 2013;12(6):664-667.
Karen E. Huang MS,a S. Evan Carstensen BS,a and Steven R. Feldman MD PhDa,b,c| |
METHODS: Electronic patient records from an academic practice were queried to identify dermatology visits with an acne diagnosis (ICD-9: 706.1) between January 1, 2009 and June 1, 2012. The duration of care for acne treatment was calculated as the time between the earliest and latest visits. Kaplan Meier analyses were used to describe treatment duration.
RESULTS: 1,130 patients had at least one visit acne-related visit to a dermatologist, with 631 (56%) having only one visit and 499 (44%) having multiple visits over the study period. For patients with multiple visits, the mean duration from first to last visit was 0.57 year (95% CI: 0.52, 0.62); 25% ceased visiting in 0.25 year, 50% in 0.40 year, and 75% in 0.64 year.
CONCLUSION: Our study provides a lower limit on the duration of acne treatment. The duration of acne treatment is longer than the duration of typical acne clinical trials. Understanding the duration of the disease can help set patients’ treatment expectations, which may help improve adherence.
J Drugs Dermatol. 2014;13(6):655-656.
Jerry Tan MD,a/sup> Sewon Kang MD,b/sup> and James Leyden MDc| |
J Drugs Dermatol. 2017;16(2):97-102.
Monique Kademian MD, Mark Bechte MD, Matt Zirwas MD| |
Alison Harvey PhD MS and Tu T. Huynh PhD| |
J Drugs Dermatol. 2014;13(4):459-463.
Deborah S. Sarnoff MD| |
Efficacy of Topical Azelaic Acid (AzA) Gel 15% Plus Oral Doxycycline 40 mg Versus Metronidazole Gel 1% Plus Oral Doxycycline 40 mg in Mild-to-Moderate Papulopustular Rosacea
James Q. Del Rosso DO FAOCD, Suzanne Bruce MD, Michael Jarratt MD, Alan Menter MD, Gerald Staedtler| |
Phase 2 Randomized, Dose-Ranging Study of Oxymetazoline Cream for Treatment of Persistent Facial Erythema Associated With Rosacea
Janet DuBois MD,a Jeffrey S. Dover MD FRCPC,b Terry M. Jones MD,c Robert A. Weiss MD FAAD FACPh,d David R. Berk MD,e and Gurpreet Ahluwalia PhDe| |
Kircik, L.H. et al.| |
Leon H. Kircik MD| |
Efficacy and Safety of Once-Daily Topical Brimonidine Tartrate Gel 0.5% for the Treatment of Moderate to Severe Facial Erythema of Rosacea: Results of Two Randomized, Double-blind, and Vehicle-Controlled Pivotal Studies
Joseph Fowler Jr. MD,a J. Mark Jackson MD,a Angela Moore MD,b Michael Jarratt MD,c Terry Jones MD,d Kappa Meadows MD,e Martin Steinhoff MD,f Diane Rudisill BSc,g and Matthew Leoni MDg on behalf of the Brimonidine Phase III Study Group| |
OBJECTIVE: To assess the efficacy and safety of topical brimonidine tartrate gel 0.5% for the treatment of erythema of rosacea.
METHODS: Both studies were randomized, double-blind, and vehicle-controlled, with identical design. Subjects with moderate to severe erythema of rosacea were randomized 1:1 to apply topical brimonidine tartrate gel 0.5% or vehicle gel once-daily for 4 weeks, followed by a 4-week follow-up phase. Evaluations included severity of erythema based on Clinician’s Erythema Assessment and Patient’s Self-Assessment, as well as adverse events.
RESULTS: Topical brimonidine tartrate gel 0.5% was significantly more efficacious than vehicle gel throughout 12 hours on days 1, 15, and 29, with significant difference observed as early as 30 minutes after the first application on day 1 (all P<.001). No tachyphylaxis, rebound or aggravation of other disease signs were observed. Slightly higher incidence of adverse events was observed for topical brimonidine tartrate gel 0.5% than for vehicle; however, most of the adverse events were dermatological, mild, and transient in nature.
LIMITATIONS: These data generated in controlled trials may be different from those in clinical practice.
CONCLUSIONS: Once-daily brimonidine tartrate gel 0.5% has a good safety profile and provides significantly greater efficacy relative to vehicle gel for the treatment of moderate to severe erythema of rosacea, as early as 30 minutes after application.
J Drugs Dermatol. 2013;12(6):650-656.
Shereen N. Mahmood MD and Whitney P. Bowe MD| |
J Drugs Dermatol. 2014;13(4):428-435.
Intense Pulsed Light Pulse Configuration Manipulation Can Resolve the Classic Conflict Between Safety and Efficacy
Inna Belenky PhD, Cruzy Tagger MD, and Andrea Bingham RE| |
J Drugs Dermatol. 2015;14(11):1255-1260.
Diane Thiboutot MD, Andrew F. Alexis MD MPH, Leon H. Kircik MD| |
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 1 category 1 CME Credit.
Leon H. Kircik MD| |
J Drugs Dermatol. 2016;15(1 Suppl 1):s7-s10.
Leon H. Kircik MD| |
J Drugs Dermatol. 2013;12(11):1268-1270.
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2016;15(1 Suppl 1):s11-s16.
Andrew C. Krakowski MD,a Lawrence F. Eichenfield, MDb| |
The Use of the Low-Fluence 1064 nm Nd:YAG Laser in a Female With Contraindications to Systemic Anti-Acne Therapy
Jason S. Ballin DO and Nathan S. Uebelhoer DO| |
Long-term Efficacy and Safety of TopicalPRK 124 (0.125%) Lotion (Pyratine-XR) in theTreatment of Mild-to-Moderate Rosacea
Anne Marie Tremaine MD, Arisa Ortiz MD, Laila Elkeeb MD, Minh Tran, Gerald Weinstein MD| |
Kavita Darji BA and Nicole M. Burkemper MD| |
Pityriasis folliculorum has been described as a dry type of rosacea with extensive proliferation of Demodex folliculorum in pilosebaceous follicles of the skin. This skin condition is frequently difficult to manage, with various treatment options showing mixed efficacy. Oral ivermectin, a macrocyclic lactone parasiticide with anti-inflammatory and anti-parasitic effects, is one of the leading treatment modalities for demodicosis. Topical ivermectin has recently been FDA approved as therapy for rosacea. We present the case of a woman with pityriasis folliculorum who showed significant improvement from using topical ivermectin with no adverse events related to treatment.
J Drugs Dermatol. 2017;16(12):1290-1292.
The Development of Antimicrobial Resistance Due to the Antibiotic Treatment of Acne Vulgaris: A Review
Mital Patel MD, Whitney P. Bowe MD, Carol Heughebaert MD, Alan R. Shalita MD| |
Diane M. Thiboutot MD, Alan B. Fleischer Jr MD, James Q. Del Rosso DO, Klaus Graupe PhD| |
Methods: The evaluable efficacy population of this 12-week double-blind, parallel-group study included 72 patients and the population that was used to report safety results included 92 patients. Baseline characteristics were comparable between the once-daily and twice-daily study groups. Evaluations were performed at baseline and at weeks 4, 8, and 12.
Results: No significant difference was found between the once-daily and twice-daily groups at the end of study therapy in mean investigator global assessment (IGA) scores, treatment success, or treatment response. The mean number of inflammatory lesions, the intensity of erythema intensity, and the intensity of telangiectasia at treatment end were likewise not significantly different (P>.205 for all). More than 90% of subjects in each group rated cosmetic acceptability of this AzA gel as satisfactory or better.
Conclusion: Based on these findings and those of prior studies, once-daily AzA 15% gel can therefore be utilized as a safe, effective, and economical dosing option for the treatment of mild-to-moderate papulopustular rosacea. Once-daily dosing of AzA 15% gel was well accepted by patients
Over 25 Years of Clinical Experience With Ivermectin: An Overview of Safety for an Increasing Number of Indications
Leon H. Kircik MD,a James Q. Del Rosso DO,b Alison M. Layton MD,c and Jürgen Schauber MDd| |
J Drugs Dermatol. 2016;15(3):325-332.
Clinical Pharmacokinetics of Oxymetazoline Cream Following Topical Facial Administration for the Treatment of Erythema Associated With Rosacea
Amy W. Kuang PhD,a Janet DuBois MD,b Mayssa Attar PhD,a Gurpreet Ahluwalia PhDa| |
Study Results of Benzoyl Peroxide 5%/Clindamycin 1% Topical Gel, Adapalene 0.1% Gel and Use in Combination for Acne Vulgaris
James Q. Del Rosso DO FAOCD| |
Management of Rosacea-Prone Skin: Evaluation of a Skincare Product Containing Ambophenol, Neurosensine, and La Roche-PosayThermal Spring Water as Monotherapy or Adjunctive Therapy
Sophie Seité PhD,a Florence Benech PharmD,b Sandrine Berdah PhD,b Muriel Bayer PharmD,b Sophie Veyrat PharmD,b Evelyne Segot PharmD PhD,b Marcela Sakalikova Mgr,c Lucia Gibejova Mgr,c Hana Zelenkova MD PhDc| |
METHODS: Several studies were performed to evaluate the efficacy of this product in the management of rosacea prone skin, as either monotherapy or adjunctive therapy or to maintain the efficacy of a Metronidazole treatment. The first study was performed on 37 women aged 18-45 with added stage 2 erythro-couperosis, who applied test formula as monotherapy twice a day for 4 weeks. During a second study, a dermatological evaluation was performed on patients with stage I or II rosacea, a questionnaire containing information about patient characteristics, tolerance, clinical signs, symptoms and skin reactivity to “trigger factors” was completed by dermatologists at baseline and 2 months after treatment with the test formula as either monotherapy or adjunctive therapy. Finally, in a third study, 65 patients finishing a Metronidazole treatment applied once daily and the tested formula twice daily were divided into 2 groups using the test formula or vehicle control, twice a day for 8 weeks for the evaluation of efficacy as adjunctive therapy.
RESULTS: We noted that the test formula, as an adjunctive therapy, helped prolong the efficacy of a Metronidazole treatment. In monotherapy, there was a significant efficacy of the test formula associated with an excellent tolerance. A significant improvement of all the clinical signs and symptoms of rosacea and a reduction of the skin reactivity to "trigger factors" were shown.
CONCLUSIONS: These studies highlight the interest value and impact of a skincare product containing Ambophenol, Neurosensine, and La Roche-Posay thermal spring water formulated in a highly protective packaging in monotherapy or in combination with or after a therapeutic treatment in the management of patients suffering from rosacea.
J Drugs Dermatol. 2013;12(8):920-924.
A Sequential Approach to the Treatment of Severe Papulopustular Rosacea Not Responding to Traditional Treatment
Thomas Dirschka MD,a,b Lutz Schmitz MD,a,c and Ágota Bartha MDa| |
J Drugs Dermatol. 2016;15(6):769-771.
Hilary E. Baldwin MD FAAD,a Ariane K. Kawata PhD,b Selena R. Daniels PharmD MS,c
Teresa K. Wilcox PhD,b Caroline T. Burk PharmD MS,d Emil A. Tanghetti MDe
OBJECTIVE: The purpose of this analysis was to evaluate health care resource utilization (HRU) and treatment patterns in cohorts with and without the use of acne medication and predictors of use.
METHODS: A cross-sectional, web-based survey was administered to US females (25–45 years) with facial acne (≥25 visible lesions). Data collected included: sociodemographics and self-reported clinical characteristics, acne treatments, and health care professional (HCP) visits. Subject characteristics associated with medication use were examined by logistic regression.
RESULTS: Approximately half of the total sample (N=208, mean age: 35±6) ever visited an HCP for acne and reported more over-the counter (OTC) medication use (51.0%) than prescription (Rx) medication use (15.4%). Subjects did not use medications daily, averaging from 12–18 days over the previous 4 weeks. Logistic regression showed that race and prior HCP visits for acne were significant predictors of medication use (P<.05).
CONCLUSIONS: Adult females generally self-treated their acne using primarily OTC medications; however, poor compliance was observed for Rx and OTC. Race and prior HCP visits for acne were significant predictors of current medication use.
J Drugs Dermatol. 2015;14(2):140-148.
Effectiveness and Safety of Once-Daily Doxycycline Capsules as Monotherapy in Patients With Rosacea: An Analysis by Fitzpatrick Skin Type
J Drugs Dermatol. 2012;11(10):1219-1222.
Efficacy and Safety of Azelaic Acid (AzA) Gel 15% in the Treatment of Post-Inflammatory Hyperpigmentation and Acne: A 16-Week, Baseline-Controlled Study
Leon H. Kircik, MD| |
J Drugs Dermatol. 2011;10(6):586-590.
Linda Stein Gold MD,a Jerry Tan MD,b and Leon Kircik MDc| |
OBJECTIVES: We evaluated differences in outcome measures and definition of success in acne trials; and their impact on FDA approval and indications for acne medications.
METHODS: Review of acne clinical trial literature, prescribing information and regulatory guidelines for currently approved acne medications in the United States.
RESULTS: Numerous IGA scales exist with variations in specific categorical definitions. There are also differences in definitions of global success. Outcome success may not be accurately translated into corresponding terminology for indications.
CONCLUSIONS: Variability in IGA scales and definitions of success confound comparison of trial results for acne treatments. Harmonization and standardization of these factors will facilitate meta-analytics and treatment selection in patient care. Outcome measure success has not consistently been incorporated into acne medication indications.
J Drugs Dermatol. 2016;15(1):79-86.
Sanjay Bhambri DO, James Q. Del RossoDO, Avani Bhambri MD| |
Karen Meyer BS, Apostolos Pappas PhD, Kelly Dunn BS, Gabriela O. Cula PhD, InSeok Seo PhD, Eduardo Ruvolo JR MS, and Nikoleta Batchvarova PhD| |
J Drugs Dermatol. 2015;14(6):593-601.
Leon H. Kircik, MD| |
Jerry K. L. Tan MD FRCPC, Jing Tang MSc, Karen Fung PhD, Aditya K. Gupta MD PhD FRCPC, D. RichardThomas MD FRCPC, Sheetal Sapra MD FRCPC, Charles Lynde MD FRCPC, Yves Poulin MD FRCPC,Wayne Gulliver MD FRCPC, Rolf J. Sebaldt MD CM FRCPC| |
Purpose: This study was designed to examine the prevalence and severity of acne on the face, chest, and back in a referral cohort of patients with acne using a validated global acne severity scale.
Methods: Acne patients referred to dermatologists were evaluated at the face, chest, and back. Chi-square testing was performed to assess consistency between patient and physician assessments of each region. The correlation of acne severity between regions was evaluated by Spearman’s rank correlation.
Results: In 965 patients, the prevalence of acne on the face, chest, and back was 92%, 45%, and 61%, respectively. Acne severity was significantly correlated for all regional pairs (P<.001): face and back (r=0.11); face and chest (r=0.12); and chest and back (r=0.67). The consistency of patient reporting and clinical evaluation for the presence of acne varied by region: face=92%, chest=69%, and back=74%. The proportions of patients reporting no occurrence of acne when clinical acne was indeed absent (negative predictive value) were 67% and 65% for the chest and back, respectively.
Limitations: The operational threshold for clinical acne (>mild) may underestimate the total proportion of affected patients. These patients were referred to dermatologists for care and may represent a more severe cohort.
Conclusion: Acne affected the face in 92% and the trunk in just over 60% (with the back more frequently and severely affected than the chest). Acne severity was observed to have a much higher correlation between chest and back than face and back or face and chest. Patient-reporting evaluations of absence of acne on the chest and back are frequently erroneous, mandating clinical evaluations of these sites for assessment of overall extent.
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2013;12(12):1418-1427.
Linda Stein Gold MD,a Hilary E Baldwin MD,b Tina Lin PharmDc| |
Acne vulgaris (acne) is the most common skin disease we see in dermatology practice. Although rare in childhood, severe acne can affect up to 12% of the adolescent population. A chronic disease, it requires both aggressive management and effective maintenance strategies. Oral antibiotics, in combination with topical agents are recommended for treatment, with topical agents being continued as maintenance therapy to minimize resistance and recurrence. However, concerns with systemic side effects have recently resulted in a greater focus on the potential of fixed combination topical therapies to treat severe acne. Here we review the available clinical evidence. There are no studies investigating the use of fixed combination topical therapy exclusively in severe acne. However, studies assessing the treatment of moderate-to-severe acne include subpopulation data in severe patients. Adapalene 0.3%-benzoyl peroxide (BP) 2.5% was found to be effective in patients with severe acne, whereas the fixed combination with a lower concentration of adapalene (0.1%) was no more effective than vehicle. Clindamycin-BP 1.2%/3.75% gel and clindamycin-BP 1.2%/2.5% gel were both found to be effective in severe acne with an apparent BP-dose response. Clindamycin phosphate 1.2%-tretinoin 0.025% demonstrated similar efficacy in severe acne, but with little benefit over individual monads. Realistic topical treatment options now exist for the management of severe acne where patient and physician preference can impact positive outcomes.
J Drugs Dermatol. 2017;16(11):1134-1138.
Treatment of Rosacea With Concomitant Use of Topical Ivermectin 1% Cream and Brimonidine 0.33% Gel: A Randomized, Vehicle-controlled Study
Linda Stein Gold MD,a Kim Papp MD PhD FRCPC,b Charles Lynde MD FRCPC,c Edward Lain MD MBA,d Melinda Gooderham MSc MD FRCPC,e Sandra Johnson MD FAAD,f and Nabil Kerrouche MScg| |
J Drugs Dermatol. 2017;16(9):909-916.
Pivotal Trial of the Efficacy and Safety of Oxymetazoline Cream 1.0% for the Treatment of Persistent Facial Erythema Associated With Rosacea: Findings from the First REVEAL Trial
Leon H. Kircik MD,a Janet DuBois MD,b Zoe Diana Draelos MD,c Philip Werschler MD FAAD FAACS,d Kimberly Grande MD,e Fran E. Cook-Bolden MD,f Emily Weng ScD MBA,g David R. Berk MD,g and Gurpreet Ahluwalia PhDg| |
J Drugs Dermatol. 2018;17(1):97-105.
Saira B. Momin DO , Aaron Peterson DO , James Q. Del Rosso DO FAOCD| |
Leon H. Kircik MD| |
Sapna Modi BA, Mandy Harting MD, Theodore Rosen MD| |
Amanda Suggs MD,a Mathew Loesch DO PhD,b Harib Ezaldein MD,a Luisa Christensen MD,a Danyelle Dawes MD,a and Elma Baron MDa,c| |
J Drugs Dermatol. 2018;17(4):380-382.
Leon H. Kircik MD| |
Lana X. Tong MD MPH and Jeremy A. Brauer MD| |
J Drugs Dermatol. 2017;16(11):1095-1102.
Acne vulgaris is the most common skin disorder seen in dermatology and primary care offices today with significant associated morbidity. The pathogenesis of acne is complex and multifactorial, and there continues to be an influx of new information to increase our understanding of this chronic disease. Recent advances in acne pathogenesis will be discussed, including theories regarding the sequence of events in acne formation, the functions of P. acnes, TLR involvement and role of the sebaceous gland and factors influencing sebum production.
J Drugs Dermatol. 2011;10(6):582-585.
A Novel Microgel Complex Delivers Acne Medicine Deep into Follicles While Demonstrating High Patient Tolerance
Jeff Wu PhD, Jeannette Chantalat MBA, Jue-Chen Liu PhD| |
J Drugs Dermatol. 2015;14(2):176-182.
An Open-label, Split-face Study Comparing the Safety and Efficacy of LevulanKerastick (Aminolevulonic Acid) Plus a 532 nm KTP Laser to a 532 nm KTP LaserAlone for the Treatment of Moderate Facial Acne
Neil Sadick MD FACP FAACS| |
Long-Term Safety of Ivermectin 1% Cream vs Azelaic Acid 15% Gel in Treating Inflammatory Lesions of Rosacea: Results of Two 40-Week Controlled, Investigator-Blinded Trials
Linda Stein Gold MD,1 Leon Kircik MD,2 Joseph Fowler MD,3 J. Mark Jackson MD,4 Jerry Tan MD,5
Zoe Draelos MD,6 Alan Fleischer MD,7 Melanie Appell MD,8 Martin Steinhoff MD PHD,9
Charles Lynde MD,10 Jeffrey Sugarman MD PhD,11 Hong Liu MSc,12 and Jean Jacovella MD13 on behalf of the Ivermectin Phase 3 Study Group
J Drugs Dermatol. 2014;13(11):1380-1386.
Efficacy and Safety of Ivermectin 1% Cream in Treatment of Papulopustular Rosacea: Results of Two Randomized, Double-Blind, Vehicle-Controlled Pivotal Studies
Linda Stein Gold MD,a Leon Kircik MD,b Joseph Fowler MD,c Jerry Tan MD,d Zoe Draelos MD,e Alan
Fleischer MD,f Melanie Appell MD,g Martin Steinhoff MD,h Charles Lynde MD,i
Hong Liu MSc,j and Jean Jacovella MDk
on behalf of the Ivermectin Phase III Study Group
OBJECTIVE: To demonstrate the efficacy and safety of once-daily ivermectin 1% cream in subjects with moderate to severe PPR.
METHODS: Two identically designed, randomized, double-blind, controlled studies of ivermectin 1% cream (IVM 1%) or vehicle once daily for 12 weeks were conducted in subjects with moderate to severe PPR. Efficacy assessments were Investigator's Global Assessment (IGA) of disease severity and inflammatory lesion counts. Safety assessments included incidence of adverse events (AEs) and local tolerance parameters. Subjects evaluated their rosacea and completed satisfaction and quality of life (QoL) questionnaires.
RESULTS: In both studies, a greater proportion of subjects in the IVM 1% group achieved treatment success (IGA “clear” or “almost clear”): 38.4% and 40.1% vs 11.6% and 18.8% for vehicle (both P<.001), respectively. Ivermectin was superior to vehicle in terms of reduction from baseline in inflammatory lesion counts (76.0% and 75.0% vs 50.0% for both vehicle groups, respectively). For all endpoints, starting at week 4 and continuing through week 12, IVM 1% was statistically significantly superior (P<.001). Fewer subjects treated by IVM 1% reported dermatologic AEs, and a higher proportion of subjects were observed to have no skin dryness or itching compared to vehicle. Significantly more subjects receiving IVM 1% reported having an “excellent” or “good” improvement, along with an improved QoL.
CONCLUSION: Ivermectin 1% cream was effective and safe in treating inflammatory lesions of papulopustular rosacea.
J Drugs Dermatol. 2014;13(3):316-323.
Tapan Patel MBBS MRCP,a Oren Tevet MScb| |
This study evaluated the clinical efficacy and safety of pneumatic injections of Hyaluronic Acid in the treatment of acne scars.
Two patients (Fitzpatrick skin type IV-V) with acne scars received two sessions of pneumatic, needleless injections of crosslinked hyaluronic acid (HA) at 4-week intervals. The treatment response was assessed by comparing pre‐ and 3‐month posttreatment clinical photography.
The patients’ acne scar grade improved from 2 to 1 in the first case, and 3 to 2 in the second case, based on independent physician assessment. Patient degree of satisfaction was similar to the physicians' assessment. No significant adverse events were noted. We conclude that pneumatic injection technology to deliver HA to the tissue is an effective and safe method for improving acne scars, even in patients with dark complexion.
J Drugs Dermatol. 2015;14(1):74-76.
Joseph Alcalay, MD| |
Jane Yoo BS MPP, David C. Reid BA, Alexa B. Kimball MD MPH| |
Purpose: To assess the relative efficacy of metronidazole cream, gel, and lotion at concentrations of 0.75% and 1%, in dosing regimens of once and twice daily.
Methods: A meta-analysis of published metronidazole efficacy rates was performed.
,br> Results: In non-weighted analysis, the mean efficacy was 28.2% (95% confidence interval [CI], 22.0%-34.4%) for the cream, 38.4% (95% CI, 18.4%-58.4%) for the gel, and 35% for the lotion. Confidence intervals for QD versus BID dosing and 0.75% versus 1% concentrations also overlapped. In weighted analysis, the mean reduction was 31.3% for the cream, 22.1% for the gel, and 35% for the lotion.
,br> Conclusions: Metronidazole cream, gel, and lotion vehicles have similar efficacies. There were no substantial differences between concentrations of 0.75% and 1%, or between once daily and twice daily regimens.
Leon H. Kircik MD| |
J Drugs Dermatol. 2014;13(4):466-470.
Expanding the Clinical Application of Fractional Radiofrequency Treatment: Findings on Rhytides, Hyperpigmentation, Rosacea, and Acne Redness
Wichai Hongcharu MDa and Michael Gold MDb| |
J Drugs Dermatol. 2015;14(11):1298-1304.
Lauren K. Hoffman BA,a Neal Bhatia MD,b Joshua Zeichner MD,b Leon H. Kircik MDc| |
Rungsima Wanitphakdeedecha MD MA MSc,Elizabeth L. Tanzi MD, Tina S. Alster MD| |
Background: A wide variety of laser and light-based therapies have been utilized for acne vulgaris; however, current techniques have been limited by photosensitivity issues or inconsistent results.
Objective: To determine the clinical efficacy and side-effect profile of photopneumatic therapy for the treatment of facial acne vulgaris.
Methods: Twenty adults with mild to severe facial acne vulgaris received 4 successive treatments at 2-week intervals with a combined photopneumatic device (intense pulsed light [IPL]: fluences=3.6-4.2 J/cm2; negative pressure=3 psi). Clinical improvement was evaluated on a quartile grading scale using comparative digital photographs at baseline, and 1 month and 3 months after the final treatment. Acne lesion counts were obtained at baseline, prior to each treatment session, and at the end of the study.
Results: Modest reduction in acne lesion counts and global clinical improvement was seen in the majority of patients. Patients with severe acne experienced the most clinical improvement. Side effects were mild and limited to transient erythema and rare purpura. Most patients experienced acne worsening early in the treatment course.
Conclusion: Photopneumatic therapy is a safe and effective treatment for acne vulgaris. Patients with more severe acne respond best to treatment.
Shlomit Halachmi, MD PhD,a Dan Ben Amitai MD,b,d and Moshe Lapidoth MD MPHc,d| |
MATERIALS and METHODS: Twelve consecutive patients with moderate to severe acne scarring, who had completed a series of fractional laser resurfacing, underwent microinjections of 20 mg/mL hyaluronic acid (HA) gel into discrete depressed acne scars on the face.
RESULTS: Immediate visual improvement was observed in all lesions. The procedure was well tolerated. Adverse events were limited to transient pinpoint bleeding at the injection site.
CONCLUSION: Microinjection of low viscosity HA offers a valuable technique for the treatment of discrete depressed acne scars.
J Drugs Dermatol. 2013;12(7):e121-e123.
Kathani Amin MD, Christy C. Riddle MD, Daniel J. Aires MD, Eric S. Schweiger MD| |
Acne is perhaps the most prevalent skin disease in Western societies, yet dermatologists are now learning that simply "dubbing the medicine on the pimples" is not the way to manage it successfully. Acne is primarily an inflammatory disease, so treatment needs to be aimed not only at eradicating existing lesions but also at preventing long-term scarring and hyperpigmentation by rapidly reducing inflammation.
Moreover, the old-fashioned way of using antibiotics long-term as monotherapy is contributing to the global public health challenge of antibiotic resistance, which requires a new treatment paradigm emphasizing antibiotic stewardship. Antibiotic limiting regimens, including a combination of topic retinoids and benzoyl peroxide, are shown to be effective; and topical probiotics can also play a useful role.
These new understandings of acne pathogenesis, treatment targets (including those in skin of color), and antibiotic stewardship are all discussed in this supplement.
Austin Liu MD, Deborah J. Yang MD, Peter C. Gerhardstein PhD, Sylvia Hsu MD| |
Methods: We conducted a retrospective study of 405 acne patients treated with isotretinoin to evaluate the incidence of recurrence after a course of at least 150 mg/kg of isotretinoin.
Results: Of the 405 patients evaluated, 94 (23.2%) experienced relapses severe enough for the patient to request further medical management. Of the 94 patients, 76 (80.9%) relapsed within the first 2 years following completion of a course of isotretinoin.
Limitations: This was a retrospective study at a single practice site.
Conclusion: Almost one-fifth of patients have a recurrence of acne within the first 2 years. Patients should be made aware of this information, as it will contribute to the development of accurate and appropriate expectations of therapy.
David Lortscher MD,a Shehla Admani MD,b Nancy Satur MD,a and Lawrence F. Eichenfield MDb,c| |
METHODS: At the time of initial consultation for acne, each of 2147 consecutive patients using hormonal contraception provided her assessment of how her contraceptive had affected her acne. The Kruskal-Wallis test and logistic regression analysis were used to compare patient-reported outcomes by contraceptive type.
RESULTS: Depot injections, subdermal implants, and hormonal intrauterine devices worsened acne on average, and were inferior to the vaginal ring and combined oral contraceptives (COCs; P ≤ .001 for all pairwise comparisons), which improved acne on average. Within COC categories, a hierarchy emerged based on the progestin component, where drospirenone (most helpful) > norgestimate and desogestrel > levonorgestrel and norethindrone (P ≤ .035 for all pairwise comparisons). The presence of triphasic progestin dosage in COCs had a positive effect (P = .005), while variation in estrogen dose did not have a significant effect (P = .880).
CONCLUSIONS: Different hormonal contraceptives have significantly varied effects on acne, including among types of COC.
J Drugs Dermatol. 2016;15(6):670-674.
Re-evaluating Treatment Targets in Acne Vulgaris: Adapting to a New Understanding of Pathophysiology
Leon H. Kircik MD| |
J Drugs Dermatol. 2014;13(suppl 6):s57-s60.
Treatment Considerations for Inflammatory Acne: Clinical Evidence for Adapalene 0.1% in Combination Therapies
Diane M. Thiboutot MD, Harald P. Gollnick MD| |
Evaluation of the Efficacy, Tolerability, and Safety of an Over-the-Counter Acne Regimen Containing Benzoyl Peroxide and Salicylic Acid in Subjects With Acne
Leon H. Kircik MD,a-c Lawrence J. Green MD,d Joseph Eastern MD,e Victoria Butners BSc,f and Jennifer Gwazdauskas MBAf| |
J Drugs Dermatol. 2013;12(3):259-264.
The understanding of acne vulgaris (AV) has evolved with a greater recognition of the sequence of inflammation, especially prelesional inflammation. An important facet of the new paradigm is that a specific follicular pattern of innate inflammation occurs before and during follicular hyperkeratinization. Moreover, this inflammation persists during the resolution of the macular phase after inflammatory lesions flatten toward the end of their life cycle. The current understanding of AV pathogenesis presents novel therapeutic options for patients because the use of benzoyl peroxide and a topical retinoid suppresses several components of acne pathogenesis, including reduced follicular hyperkeratinization, decreased innate inflammation, and dermal matrix degradation.
Efficacy and Tolerability of a Fixed Combination of Clindamycin Phosphate (1.2%) and Benzoyl Peroxide (3.75%) Aqueous Gel in Moderate and Severe Acne Vulgaris Subpopulations
Linda Stein Gold MD| |
METHODS: Multicenter, double-blind study in 498 patients with moderate or severe acne randomized to clindamycin-BP 3.75% or vehicle, once-daily for 12 weeks. Efficacy evaluations included inflammatory and noninflammatory lesion counts and evaluator’s global severity at baseline, and at weeks 4, 8, and 12. Adverse events (AEs) and tolerability were also assessed. This was a post hoc analysis of moderate and severe acne populations.
RESULTS: Clindamycin-BP 3.75% significantly reduced inflammatory and noninflammatory lesions in both moderate and severe acne patients compared with vehicle. More than half of the patients with severe acne (55.1%) had at least a 2-grade reduction in evaluator’s global severity score by week 12, and 30.6% of patients assessed their acne as ‘clear’ or ‘almost clear’. Clindamycin-BP 3.75% was well tolerated, with no substantive differences from vehicle; and no patient discontinued due to AEs.
CONCLUSIONS: Clindamycin-BP 3.75% aqueous gel is an effective and well-tolerated once-daily topical treatment for both moderate and severe acne
J Drugs Dermatol. 2015;14(9):969-974.
Alan Menter, MD| |
Topical corticosteroids, however, including low-potency fluocinolone acetonide, also exert an anti-metabolic effect, resulting in decreased epidermal turnover, and, thus, may produce a mild depigmenting effect. When used in combination with tretinoin and hydroquinone in the treatment of melasma, fluocinolone acetonide 0.01% suppresses biosynthetic and secretory functions of melanocytes, and thus melanin production, leading to early response in melasma, synergy among the three agents, and no significant side effects over an 8-week period.
Comparison of Anti-inflammatory Dose Doxycycline Versus Doxycycline 100 mg in the Treatment of Rosacea
James Q. Del Rosso DO, Joel Schlessinger MD, Philip Werschler MD| |
Over the last 4 decades, topical retinoids have become standard therapy for the treatment of acne vulgaris. Although the market currently encompasses multiple formulations of next-generation topical retinoids, Tazorac is unique among them due to its dual role as a treatment option for both acne vulgaris and psoriasis vulgaris. Tazorac has also demonstrated that it is highly effective for the treatment of acne vulgaris as a monotherapy or in combination with other agents. Recent studies show that Tazorac can be combined effectively with dapsone 5% gel or with a benzoyl-peroxide - containing formulation to augment efficacy. Additionally, Tazorac does not have a generic substitution, so physicians can be assured that their patients will receive exactly what they have been prescribed.
A Single-Center Study of Aminolevulinic Acid and 417 nm Photodynamic Therapy in the Treatment of Modrate to Severe Acne Vulgaris
Mitchel P. Goldman, MD and Sarah M. Boyce, MD| |
Optical Coherence Tomography Imaging of Erythematotelangiectatic Rosacea During Treatment With Brimonidine Topical Gel 0.33%: A Potential Method for Treatment Outcome Assessment
Jennifer Urban BS,a Arunee H. Siripunvarapon MD,b Adam Meekings BS,c
Amy Kalowitz BS,b and Orit Markowitz MD FAADb
OBJECTIVE: To examine and describe how OCT skin morphology changes when exposed to brimonidine topical gel 0.33% in the treatment of erythematotelangiectatic rosacea.
METHODS: Normal in vivo telangiectasias and erythematous patches and papules were examined prior to treatment clinically, dermatoscopically, and through OCT scans. Brimonidine topical gel 0.33% was applied to the face and OCT images were acquired at defined time intervals: baseline; immediately (<5 minutes) after application; 4 hours after application; and after 2 weeks’ once daily application. OCT morphology was then described.
RESULTS: OCT imaging showed an increase in the mean gray value (MGV), a measure of dermal reflectivity, corresponding to a decrease in dermal edema. MGV measurements for the nasal telangiectasia were: baseline, MGV 10,471 (standard deviation [SD] 6,847); immediate, MGV 15,634 (SD 8,983); after 4 hours, MGV 16,357 (SD 7,647); and after 2 weeks, MGV 15,505 (SD 6,870). MGV measurements for the chin erythema were: baseline, MGV 8,850 (SD 4,969); immediate, MGV 10,799 (SD 5,266); after 4 hours, MGV 12,419 (SD 6,714); and after 2 weeks, MGV 13,395 (SD 6,170). No significant change in vessel lumen diameter was appreciated. Vessel lumen diameter for the facial papule ranged from 0.13 mm at baseline, 0.09 mm immediately after treatment, 0.09 mm after 4 hours, and 0.11 mm after 2 weeks.
CONCLUSIONS: OCT scanning showed a decrease in the dermal hyporeflectivity of the dermis consistent with a decrease in dermal edema. The OCT scans obtained did not show any significant change in vessel lumen diameter. These results may reflect an increase in vascular tone, which can be attributable to the clinical improvement and decreased erythema noted in the patient. This technology could potentially be used for the non-invasive in vivo monitoring of other topical treatments.
J Drugs Dermatol. 2014;13(7):821-826.
Richard Fried MD PhD and Marge Nighland BS| |
Diane Thiboutot MD,a Brigitte Dreno MD PhD,b Harald Gollnick MD,c Vincenzo Bettoli MD,d Sewon Kang MD,e James J. Leyden MD,f Alan Shalita MD,g and Vicente Torres MDh for the Global Alliance to Improve Outcomes in Acne| |
Improvement in Facial Erythema Within 30 Minutes of Initial Application of Brimonidine Tartrate in Patients With Rosacea
J. Mark Jackson MD,a Joseph Fowler MD,a Angela Moore MD,b Michael Jarratt MD,c Terry Jones MD,d
Kappa Meadows MD,e Martin Steinhoff MD,f Diane Rudisill BSc,g and Matthew Leoni MDg
on behalf of the Brimonidine Phase III Study Group
OBJECTIVES: To assess the 30-minute speed of onset of topical BT 0.5% gel in reducing facial erythema in Phase III studies as measured by subject and clinician assessments of erythema.
METHODS: Two Phase III, randomized, controlled studies with identical design in which subjects with moderate erythema of rosacea (study A: n=260; study B: n=293) were randomized 1:1 to apply topical BT 0.5% or vehicle gel once-daily for 4 weeks. Evaluations included severity of erythema based on Clinician’s Erythema Assessment (CEA) and Patient’s Self-Assessment (PSA) prior to study drug application and at 30 minutes after application on days 1, 15, and 29.
RESULTS: 97.7% and 96.6% of subjects reported normal study completion for studies A and B, respectively. The percentage of subjects achieving a 1-grade improvement in both CEA and PSA was significantly increased at 30 minutes post-dosing with BT 0.5% gel compared to vehicle gel on visit days (day 1: 27.9 vs 6.9%, P<0.001; day 15: 55.9 vs 21.1%, P<0.001; Day 29: 58.3 vs 32.0%, P<0.001 for BT 0.5% gel vs vehicle) in study A. Similar results were shown for study B.
CONCLUSIONS: Once-daily topical BT gel 0.5% is not only efficacious at reducing facial erythema but also exhibits response within 30 minutes of application in a significant number of patients throughout both Phase III studies.
J Drugs Dermatol. 2014;13(6):699-704.
Lauren K. Hoffman BS,a James Q. Del Rosso DO,b and Leon H. Kircik MDc| |
INTRODUCTION: Truncal acne is often associated with facial acne, but there are fewer options for an effective topical treatment on the trunk. Given the advent of foam formulations with enhanced percutaneous absorption and convenient application due to easy spreadability on skin, the previously held idea that effective treatment of truncal acne requires oral treatment is challenged. Azelaic acid cream has been previously approved for acne vulgaris, thus azelaic acid foam may be a viable treatment option for truncal acne.
STUDY DESIGN: A single-center, open label pilot study was conducted to investigate the efficacy and safety of azelaic acid 15% foam as a treatment modality for moderate truncal acne. Use for facial acne was also allowed and monitored during the study.
RESULTS: Twice-daily application of azelaic acid 15% foam to affected areas resulted in a 1-grade reduction in truncal investigator global assessment (IGA) scores in nearly all patients (16/18). Eight out of 18 patients (44%) were rated as Clear or Almost Clear in the trunk by the end of the study. There were also improvements in facial IGA scores; 9 of 18 patients (50%) exhibited a 1-grade improvement in IGA scores and 11 of 18 were Clear or Almost Clear by the end of the study. A significant reduction in lesion counts was found throughout the study and the medication was well tolerated.
CONCUSION: Azelaic acid 15% foam was effective in treating moderate truncal acne and facial acne in this pilot study. Given the efficacy and convenience of the foam vehicle, azelaic acid may be considered as a viable option for treatment of acne vulgaris, including on the trunk. Further studies are suggested in a larger population of patients, including adult females with acne.
J Drugs Dermatol. 2017;16(6):534-538.
Brad A. Yentzer MD, Hilary Baldwin MD, Alan R. Shalita MD, Guy Webster MD, Steven R. Feldman MD PhD| |
Martin Braun MD| |
Whitney P. Bowe MD| |
J Drugs Dermatol. 2014;13(suppl 6):s66-s70.
2017 ODAC CONFERENCE ARTE POSTER WINNER: Bioinformatics Analysis of the Inflammatory Acne Transcriptome Supports Mechanisms of Action for Current Treatments and Predicts Novel Therapies In Vivo
Rivka C. Stone MD PhD and Marjana Tomic-Canic PhD| |
J Drugs Dermatol. 2017;16(11):1166-1169.
James Q. Del Rosso DO| |
Randomized, Controlled, Evaluator-Blinded Studies Conducted to Compare the Efficacy and Tolerability of 3 Over-the-Counter Acne Regimens in Subjects With Mild or Moderate Acne
Lawrence Green MD,a Leon H. Kircik MD,b-d and Jennifer Gwazdauskas MBAe| |
Objectives: To compare the efficacy, user satisfaction, and tolerability of the OTC regimens MaxClarity™, Proactiv®, and Murad® in the treatment of mild and moderate acne. Methods: Two randomized, evaluator-blinded, split-face studies were conducted, each involving 20 subjects with acne, to evaluate MaxClarity against Proactiv (study 401) and MaxClarity against Murad (study 404) over 8 weeks.
Results: Clinically and statistically significant reductions in acne lesion counts were achieved at 8 weeks compared with baseline for each regimen using MaxClarity, Proactiv, and Murad. Similar reductions in lesion counts and improvements in Investigator's Static Global Assessment grades were observed between MaxClarity and either Proactiv or Murad, in the respective studies. MaxClarity was well tolerated, with no treatment-related adverse events observed in any treatment group and no discontinuations due to adverse events. Overall, most subjects were satisfied with all study treatments.
Conclusions: MaxClarity is an effective alternative to either Proactiv or Murad for use in the treatment of mild and moderate acne.
J Drugs Dermatol. 2013;12(2):180-185.
Wm. Philip Werschler MD FAAD FAACS,a Julius W. Few Jr. MD,b Carolyn I. Jacob MD FAAD,c
John H. Joseph MD,d James M. Spencer MD MS,e and Amy Forman Taub MDf
J Drugs Dermatol. 2016;15(5):518-525.
Zoe Diana Draelos MD| |
AIM: This research evaluated the efficacy of a three step acne treatment regimen containing stabilized botanical anti-inflammatory ingredients as compared to a currently marketed acne regimen.
METHOD: 80 female/male subjects 12+ years with mild to moderate acne (at least 10 inflammatory and 10 non-inflammatory lesions) were enrolled for 12 weeks and randomized to use the study botanical anti-inflammatory acne regimen or the traditional benzoyl peroxide comparator. Evaluations included investigator global assessment, investigator tolerability assessment, acne lesion characteristics (erythema, lesion height, diameter of inflammation, and amount of pus), subject product assessment, and digital photos at baseline, 2, 4, and 12 weeks.
RESULTS: The botanical regimen outperformed the comparator in terms of target lesion erythema, height, inflammation, and pus at weeks 2 and 4, perhaps due to anti-inflammatory ingredients, however parity was reached between the two products by week 12. No difference in lesion counts between the two groups was noted at week 2, however by week 4, there was a lower lesion count with the study regimen in terms of closed comedones (P<0.001) and inflammatory (P=0.016) lesions than the comparator. This statistically significant difference continued into week 12 with a reduction in closed comedones (P=0.006) for the study regimen.
CONCLUSION: Modern OTC cosmetic formulation ingredients including emollients, anti-inflammatory/antioxidants, and sensitive skin modulators provided an improved skin appearance, less lesional erythema, and a better overall appearance in subjects with acne treated for 12 weeks.
J Drugs Dermatol. 2015;14(12):1418-1421.
Robert Bissonnette MD, Catherine Maari MD, Simon Nigen MD, Nathalie Provost MD, Chantal Bolduc MD| |
Photodynamic Therapy With Topical 5% 5-Aminolevulinic Acid for the Treatment of Truncal Acne in Asian Patients
Yik Weng Yew MD MPH,a Yi Chun Lai MD MPH,b Yen Loo Lim MD,a Wei-Sheng Chong MD,a and Colin Theng MDa| |
AIM: To determine the efficacy, safety and tolerability of 5% ALA PDT in the treatment of truncal acne in Asians.
METHODS: Patients with truncal acne were treated with 5%-ALA under occlusion for 3 hours. All were subsequently treated with a red light source at wavelength 630 nm and an irradiance of 38mW/cm2 giving a total dose of 37 J/cm2. The numbers of acne lesions were recorded at baseline and regular intervals after treatment together with any adverse effects.
RESULTS: Fifteen patients were recruited. Overall, there was a 64.2% reduction in the inflammatory lesions count and a 24.3% reduction in the non-inflammatory lesions count at the end of the 12 weeks follow-up. Both mean lesions counts were significantly lower than baseline at all follow-up time points with paired t tests (all P values <0.05). Pain was well tolerated among our patients.
CONCLUSION: A single treatment session of 5%-ALA PDT was effective for the treatment of truncal acne with little side effects and acceptable in our Asian patients.
J Drugs Dermatol. 2016;15(6):727-732.
Parviz Toossi MD, Mehdi Farshchian MD, Farhad Malekzad MD, Nahid Mohtasham MD, Arash Kimyai-Asadi MD| |
Objective: The purpose of this study was to compare the efﬁcacy of doxycycline at antimicrobial and subantimicrobial doses for the treatment of acne.
Methods: A prospective, randomized, double-blind, controlled trial was performed. One hundred patients with moderate facial acne were randomized into 2 treatment groups, one receiving a tablet containing 20 mg of doxycycline to be taken twice daily and the other receiving a tablet containing 100 mg of doxycycline and a matching placebo tablet to be taken twice daily.
Results: Subantimicrobial-dose doxycycline administered twice daily for 3 months in patients with moderate inﬂammatory acne results in signiﬁcant reduction in the number of total inﬂammatory lesions. There was an 84% reduction in number of papules and a 90% reduction in number of pustules with treatment.
Conclusion: Subantimicrobial-dose doxycycline is an effective treatment for patients with moderate acne vulgaris.
The Effect of an Anti-Inflammatory Botanical Cleanser/Night Mask Combination on Facial Redness Reduction
Zoe Diana Draelos MDa and Angela Donald ND MScb| |
Kyle B. Bartlett MD,a Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c| |
OBJECTIVE: To examine how tolerability is assessed, tolerability ratings, and clinical significance of tolerability ratings of topical antimicrobials for acne.
METHODS: A literature search was performed using the terms “tolerability AND acne AND (benzoyl peroxide OR antimicrobial OR clindamycin OR erythromycin OR dapsone OR sulfur OR sulfacetamide).” Inclusion criteria were: 1) evaluation of tolerability, 2) use of an identified topical antimicrobial for acne treatment without combination retinoid use, 3) an original study, in English.
RESULTS: Thirty-four of 132 articles met the inclusion criteria. Tolerability was measured through subject and investigator assessment of specific tolerability parameters and by reporting of adverse events. Nearly all of the acne treatments were well tolerated. Treatment related study discontinuation rates were low and had little to no relation to the degree of tolerability measures.
LIMITATIONS: Patients may be more adherent in clinical trials than in clinical practice. Differences in the measure used to assess tolerability make comparisons difficult.
CONCLUSIONS: Topical antimicrobial acne therapy is generally well tolerated. Discontinuation rates are low under study conditions. Tolerability of topical antimicrobial therapy for acne may not have great clinical significance.
J Drugs Dermatol. 2014;13(6):658-662.
Jerry Tan MD FRCPC,a Valérie Bourdès MD MPH,b Robert Bissonnette MD,c Laurent Petit B. Eng,b Philippe Reynier PhD,b Amir Khammari PhD,d and Brigitte Dreno MD PhDd| |
BACKGROUND: There are few studies on the natural history of acne lesions including the antecedents of atrophic scars.
STUDY DESIGN: Prospective study of relationship between primary (papules, pustules, comedones) and secondary lesions (atrophic scars, macular erythema, and hyperpigmentation) over 6 months. Subjects (n=32) had moderate facial acne including 10 or more atrophic acne scars and were their own control via randomized split-face design. Lesions were mapped 2x/week for 2 months and every 2 weeks thereafter until month 6 to track pathogenic progression.
RESULTS: Clinical assessment showed acne scars continuously forming throughout the 6-month study period. While the majority (66.2%) of these scars did not resolve by study endpoint, the remainder were transient. The likelihood of a scar developing from a primary acne lesion was 5.7%, and almost all scars arose from erythematous macules or hyperpigmentation (83%) and some (16%) developed directly from papules and pustules. Duration of papules was a key factor in the risk of scarring. The majority (81.7%) of the scars remaining at 6 months were still present at 2-year follow-up.
CONCLUSIONS: Atrophic acne scars continuously form, some resolve, and evolve primarily from inflammatory and post-inflammatory lesions. Clinicians should closely monitor patients with macular erythema for scarring.
J Drugs Dermatol. 2017;16(6):566-572.
Sachin V. Patwardhan PhD,a Joseph R. Kaczvinsky PhD,b James F. Joa BA,b and Douglas Canfield BSa| |
VISIA-CR is a multi-spectral and multi-modal facial imaging system. It captures fluorescence images of Horn and Porphyrin, absorption images of Hemoglobin and Melanin, and skin texture and topography characterizing broad-spectrum polarized and non-polarized images. These images are analyzed for auto-classification of inflammatory and non-inflammatory acne lesion, measurement of erythema, and post-acne pigmentation changes. In this work the accuracy of this acne lesion auto-classification technique is demonstrated by comparing the auto-detected lesions counts with those counted by expert physicians. The accuracy is further substantiated by comparing and confirming the facial location and type of every auto-identified acne lesion with those identified by the physicians. Our results indicate a strong correlation between manual and auto-classified lesion counts (correlation coefficient >0.9) for both inflammatory and non inflammatory lesions.
This technology has the potential to eliminate the tedium of manual lesion counting, and provide an accurate, reproducible, and clinically relevant evaluation of acne lesions. As an aid to physicians it will allow development of a standardized technique for evaluating acne in clinical research, as well as accurately choosing treatment options for their patients according to the severity of a specific lesion type in clinical practice.
J Drugs Dermatol. 2013;12(7):746-756.
Lawrence F. Eichenfield MD,1 James Q. Del Rosso DO FAOCD,2 Anthony J. Mancini MD,3
Fran Cook-Bolden MD,4 Linda Stein Gold MD,5 Seemal Desai MD FAAD,6 Jonathan Weiss MD,7
David Pariser MD,8 Joshua Zeichner MD,9 Neal Bhatia MD,10 Leon Kircik MD11
J Drugs Dermatol. 2015;14(3):263-268.
A Multicenter Clinical Evaluation of the Treatment of Mild to Moderate Inflammatory Acne Vulgaris of the Face with Visible Blue Light in Comparison to Topical Clindamycin Antibiotic Solution
Michael H. Gold MD, Jaggi Rao MD, Mitchel P. Goldman MD, Tancy M. Bridges NP, Virginia L. Bradshaw NP, Molly M. Boring NP, April N Guilder RN| |
Evaluation of Clinical Improvement in Acne Scars and Active Acne in Patients Treated With the 1540-nm Non-Ablative Fractional Laser
María José Isarría MD, Paloma Cornejo MD, Estefanía Muñoz BSc, Josefina Royo de la Torre MD, Javier Moreno Moraga MD| |
Introduction. Acne is a characteristic condition of puberty; however, adults who continue to have acne outbreaks frequently attend dermatology clinics. Two conditions—active acne and residual scarring—often co-occur in these patients. The objective of the present study was to evaluate the improvement in scarring and active acne after treatment with a 1540-nm erbium: glass fractional laser.
Material and Methods. The authors treated 20 patients with acne and scarring. Each patient received panfacial treatment in four sessions with a 1-month interval between sessions. Patients, the treating physician and a blinded observer evaluated the results in four areas: improvement in scars, improvement in pores, improvement in acne, and improvement in sebum secretion. Improvements were graded using the Global Aesthetic Improvement Scale. The evaluation was made 12 weeks after treatment finished.
Results. Patients presented an improvement in both acne and scars. In 80 percent of cases, patients felt that the appearance of the scars had improved, and the improvement was classified as very much improved in 40 percent. In 85 percent of cases, patients felt that active acne had improved, and the improvement was classified as very much improved in 45 percent. Pore size was evaluated as improved by 75 percent of patients. Sebum secretion improved in 80 percent of cases.
Conclusion. A 1540-nm non-ablative fractional laser provides effective treatment of acne scars. Patient satisfaction is high and active acne lesions improve significantly. Treatment of this mixed condition (scarring and active acne) with a single device is reliable, with a favorable safety profile and a high degree of patient acceptance.
J Drugs Dermatol. 2011;10(8):916-921.
Antonella Melina MSc,a Nhan Ngo Dinh MSc,b Benedetta Tafuri MSc,c Giusy Schipani MD,d Steven Nisticò MD,d Carlo Cosentino PhD,a Francesco Amato PhD,a Diane Thiboutot MD,e Andrea Cherubini PhDb| |
Whitney P. Bowe MDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2014;13(suppl 7):s89-s94.
Whitney Bowe MD and Mary-Margaret Kober MD| |
Patrick Bitter Jr. MD| |
Leon H. Kircik MD| |
J Drugs Dermatol. 2013;12(suppl 6):s73-s76.
Lawrence F. Eichenﬁeld MD, Marge Nighland BS, Ana Beatris Rossi MD, Fran Cook-Bolden MD, Pearl Grimes MD, Richard Fried MD PhD, Sharon Levy, PUMP Study Group| |
Leon H. Kircik MD FAAD| |
J Drugs Dermatol. 2012;11(6):708-713.
Joseph F. Fowler Jr. MD, Heather Woolery-Lloyd MD, Heidi Waldorf MD, Ritu Saini MD| |
Efficacy and Safety of Tretinoin 0.025%/Clindamycin Phosphate 1.2% Gel in Combination With Benzoyl Peroxide 6% Cleansing Cloths for the Treatment of Facial Acne Vulgaris
Joshua A. Zeichner MD, Madelaine Haddican MD, Rita V. Linkner MD, and Vicky Wong BS| |
J Drugs Dermatol. 2013;12(3):277-282.
Rapid Treatment of Mild Acne With a Novel Skin Care System Containing 1% Salicylic Acid, 10% Buffered Glycolic Acid, and Botanical Ingredients
Ashish C. Bhatia MDa,b and Felipe Jimenez PhDc| |
J Drugs Dermatol. 2014;13(6):678-683.
Efficacy and Tolerability of a Fixed Combination of Clindamycin Phosphate (1.2%) and Low Concentration Benzoyl Peroxide (2.5%) Aqueous Gel in Moderate orSevere Acne Subpopulations
Guy Webster MD PhD, Phoebe Rich MD, Michael H. Gold MD, Serena Mraz MD, Barry Calvarese MS, Diana Chen MD| |
Objective: To evaluate the efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BP 2.5%) aqueous gel in the treatment of moderate or severe acne subpopulations.
Methods: Two multicenter, double-blind studies randomized 2,813 subjects with moderate or severe acne to clindamycin-BP 2.5% gel, each active ingredient, or vehicle gel, once daily for 12 weeks. Efficacy evaluations included inflammatory and non-inflammatory lesion counts and evaluator’s global severity score at baseline and weeks 4, 8 and 12. Adverse events and subjects’ evaluations of product tolerability were also monitored. Subpopulation efficacy and safety analyses by baseline acne severity were performed for the combined data from the two phase 3 studies.
Results: Clindamycin-BP 2.5% gel significantly reduced inflammatory, non-inflammatory and total lesions compared with each active ingredient and vehicle in subjects with moderate acne and compared with vehicle in severe acne subjects at week 12. Significant improvements in evaluator’s global severity score were evident for subjects with moderate acne in the clindamycin-BP 2.5% group compared with each active ingredient and vehicle and compared with vehicle in subjects with severe acne at week 12. Rates of adverse events were low and similar between treatment groups and baseline acne severity.
Conclusion: Clindamycin-BP 2.5% aqueous gel is an effective and safe once-daily treatment for moderate or severe acne.
Eric S. Schweiger MDa,b and Lauren Sundick RPA-Ca| |
OBJECTIVE: To evaluate the safety and efficacy of a focal approach to fractional CO2 laser treatment for acne scars, coined “Focal Acne Scar Treatment” or “FAST”
PATIENTS and METHODS: This retrospective case series was conducted at Schweiger Dermatology, in New York, NY, with patients treated from November 2011 through May 2012. Overall, six patients (ages 18 to 48) were treated with the fractional CO2 laser resurfacing, using a so called “FAST” technique treating only the acne scars and leaving normal skin untreated. Evaluation was based on physician and patient assessment of improvement at one week and four weeks post-treatment.
RESULTS: All six patients treated with the Focal Acne Scar Treatment technique of fractional CO2 laser resurfacing had significant improvement post treatment ranging from 40% to 70% as estimated by the treating dermatologist and patient at four weeks post treatment. Patient satisfaction was high following FAST method. Temporary post-inflammatory hyperpigmentation was seen in two patients but resolved after a single 1550 nm Erbium Glass fractional laser treatment.
CONCLUSION: The Focal Acne Scar Treatment technique is an effective method of improving the appearance of atrophic acne scars. Higher energy and density levels can be used when utilizing this technique, resulting in improved outcomes when compared with whole face fractional CO2 laser resurfacing. Healing is improved and faster with this technique and no increased incidence of permanent adverse events were found. More studies are needed to further evaluate this new technique.
J Drugs Dermatol. 2013;12(10):1163-1167.
The Safety and Efficacy of Clindamycin Foam 1% versus Clindamycin Phosphate Topical Gel 1% for the Treatment of Acne Vulgaris
Alan Shalita MD, Judith A. Myers, Lincoln Krochmak MD, Alex Yaroshinsky PhD| |
Edwardo Tschen, MD and Terry Jones, MD| |
Treatment of Moderate to Severe Inflammatory Acne Vulgaris: Photodynamic Therapy with 5-Aminolevulinic Acid and a Novel Advanced Fluorescence Technology Pulsed Light Source
Michael H. Gold MD, Julie Biron BS| |
Andrew F. Alexis MD MPH| |
J Drugs Dermatol. 2014;13(suppl 6):s61-s65.
The Efficacy and Safety of Topical Dapsone Gel, 5% for the Treatment of Acne Vulgaris in Adult Females With Skin of Color
Andrew F. Alexis MD MPH,a Cheryl Burgess MD,b Valerie D. Callender MD,c Jo L. Herzog MD,d Wendy E. Roberts MD,e Eric S. Schweiger MD,f Toni C. Stockton MD,g and Conor J. Gallagher PhDh| |
OBJECTIVE: Evaluate safety and efficacy of dapsone gel, 5% applied topically twice daily for 12 weeks in women with SOC.
METHODS: Females with SOC aged 18 years and older with facial acne participated in a multicenter, open-label, single-group, 12-week pilot study of twice-daily monotherapy with dapsone gel, 5%. The investigator-rated 5-point Global Acne Assessment Score (GAAS) was used to assess efficacy. The impact of acne on subjects was assessed using the validated Acne Symptom and Impact Scale (ASIS).
RESULTS: The study enrolled and treated 68 women with SOC and facial acne. GAAS decreased significantly from baseline to week 12 (mean, -1.2 [95% CI, -1.4, -1.0]; P<.001), a 39.0% improvement. Overall, 42.9% of subjects were responders based on a GAAS of 0 or 1 at week 12. Subjects also experienced significant reductions in mean total lesions (52% decrease), inflammatory lesions (65%), and comedo counts (41%; all P<.001). Dapsone gel, 5% monotherapy was associated with significant improvement in subject-assessed acne signs (P<.001) and impact on quality of life (QOL; P<.001), based on ASIS. Dapsone gel, 5% used twice daily was well tolerated, with no treatment-related adverse events. The local dermal tolerability scores tended to remain stable or decrease from baseline to week 12.
CONCLUSIONS: Monotherapy with dapsone gel, 5% administered twice daily was safe and effective for treatment of facial acne in women with SOC. Significant improvement in overall acne severity and both inflammatory lesions and comedones was observed. Further, study subjects reported considerable improvement in both acne signs and impact on QOL.
J Drugs Dermatol. 2016;15(2):197-204.
New Insights Into Ideal Skin Care for the Acne Patient: Addressing Skin Barrier Disruption, Oil Control, and Ultraviolet Protection Through Advanced Formulations
Cetaphil® DermaControl™ Moisturizer SPF 30 (Galderma Laboratories, L.P., Fort Worth, Texas) is a new widely available and affordable skin care therapy specifically designed for use by patients with acne-prone skin and acne-affected skin. Its state-of-the-art psuedoceramide technology helps maintain barrier function without adding excessive surface greasiness, which leads to better compliance and fewer side effects; and it also provides protection against ultraviolet radiation.
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 1 AMA PRA Category 1 Credit.
Self-Reported Treatment Impressions and Satisfaction of Papulopustular Rosacea Patients Treated With Doxycycline, USP, 40 mg Capsules
Sandra Marchese Johnson MDa and Paul LeVine SMb| |
Objectives: This survey program was designed to evaluate patients' experiences with doxycycline, USP, 40 mg capsules (30 mg immediate release, 10 mg delayed release beads, ORACEA®; Galderma Laboratories, L.P.) as a treatment for the inflammatory lesions of rosacea and to provide patient-reported feedback to physicians.
Methods: This prospective, cross-sectional survey was implemented in January 2010. One thousand, two hundred and ninety-five physicians identified patients eligible for treatment with doxycycline, USP, 40 mg capsules and provided them with information about the program. Patients voluntarily participated by contacting a program coordinator or by enrolling online, providing consent, and responding to a series of questions prior to medication use and approximately four weeks post-treatment initiation. Surveys were completed through an automated interactive voice response system or a dedicated, secure website and included questions regarding patients' perceptions of when the treatment first started working, patients' symptom severity, interference of symptoms with work and social activities, and confidence in appearance. Patients were also asked about prior medication use, adjunct medication use, and treatment satisfaction. Reports of patient progress and responses to these survey questions were sent directly to each patient's treating physician within a few days of survey completion. Paired t-tests were used to evaluate the statistical significance of differences in symptom severity, interference and confidence ratings before and after treatment.
Results: Two thousand, eight hundred ninety-eight patients enrolled in the survey program and completed the baseline survey. Of these, a total of 1,346 patients completed the baseline and four-week survey (mean age 50 years; 75% female). Most (58%) reported use of a prior prescription medication to treat rosacea. Over half the patients (52%) responded that the product began to work within two weeks of use. After four weeks of using doxycycline, USP, 40 mg capsules, patients felt that the severities of redness as well as bumps/blemishes were significantly reduced (P<.05). Patients also reported having more confidence with their skin's appearance (P <.05). In addition, with use of doxycycline, USP, 40 mg capsules, patients reported significant reductions in the interference of symptoms with work and social activities (P<.05). Satisfaction with doxycycline, USP, 40 mg capsules averaged 6.8 on a scale of 1 (not at all satisfied) to 9 (very satisfied) for patients using only doxycycline, USP, 40 mg capsules; mean satisfaction was 6.7 for those using it with adjunct medication. Seven patients reported 11 adverse events during the program, including lack of efficacy, joint injury with fatigue, dizziness, back pain, bloating and constipation, increased facial redness and pimples, yeast infection, sore throat, increased bruising and worsening of rosacea.
Conclusion: Satisfaction with doxycycline, USP, 40 mg capsules for the treatment of papulopustular rosacea was apparent from patient-rated measures of treatment impact. Patients with papulopustular rosacea reported improvement in symptoms, reductions in the interference of symptoms with life's activities and satisfaction with treatment with doxycycline, USP, 40 mg capsules.
J Drugs Dermatol. 2011;10(12):1376-1381.
Effectiveness and Safety of Modified-Release Doxycycline Capsules Once Daily for Papulopustular Rosacea Monotherapy Results from a Large Community-Based Trial in Subgroups Based on Gender
J Drugs Dermatol. 2012;11(6):703-707
Toni C. Stockton MD,a Emil A. Tanghetti MD,b Edward Lain MD,c Joshua A. Zeichner MD,d and Nancy Alvandi PhDe| |
Charles W. Lynde MD FRCPC and Anneke Andriessen PhD| |
METHODS: Prior to the consensus meeting, the panel members filled out a survey on their current practice using topical treatment for acne. A literature review was carried out using information obtained from PubMed, Cochrane Library, Medline, and EMBASE. During a consensus meeting organized at the Spring Dermatology Update on April 27, 2014 in Toronto, ON, the panel had a blind vote on the issues at hand.
RESULTS: The panel reached consensus on: 1) Antibiotics are an integral part of acne treatment not only due to their antibiotic effect but also by their anti-inflammatory action. 2) Oral antibiotics should be used for a short period of time if possible. 3) Topical antibiotics should not be used in monotherapy. 4) Retinoids are effective in reducing antibiotic resistance. 5) A benzoyl peroxide wash is as effective as topical benzoyl peroxide in reducing antibiotic resistance. 6) Therapy needs to be re-evaluated in 6-8 weeks versus 12 weeks. The recommendations given by the panel are to be disseminated to both general practitioners and dermatologists.
CONCLUSION: For mild to moderate acne treatment, topical antibiotics in monotherapy are not to be used but may be combined with a retinoid or BPO to safely achieve more successful outcomes.
J Drugs Dermatol. 2014;13(11):1358-1364.
Jonathan S. Weiss, MD and Joel S. Savin, MD| |
This article will examine the individual agents used in combination for acne management, and discuss the mechanisms by which they achieve efficacy. The rationale of utilizing topical retinoids with antibiotics will be highlighted, particularly in relation to improved tolerance and reduced irritation.
Case-Based Experience With the Simultaneous Use of a Fixed Topical Antibiotic/Benzoyl Peroxide Combination and a Topical Retinoid in theOptimization of Acne Management
Chérie M. Ditre MD| |
Magdalene Dohil MD, Leslie Baumann MD, Hema Sundaram MD, Jason Emer MD| |
Providing optimal patient outcomes continues to be a challenge in the treatment and management of dermatologic conditions. Most physicians and patients are interested in doing everything possible to optimize the treatment of their skin disease. This is especially important in treating patients with chronic disorders such as eczema, acne, psoriasis, rosacea, photodamage and the negative effects of aging. Physicians and patients often explore the therapeutic benefits of natural ingredients as alternative or complementary treatments to conventional methods. It is important that dermatologists remain up-to-date on the research and new advances in skin care products with natural ingredients.
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 1 category 1 CME Credit.
Esra Adışen MD, Yeşim Kaymak MD, Mehmet Ali Gurer MD, Elif Durukan PhD| |
Objectives: The objective of this study was to evaluate the effectiveness of a new formulation of topical tetracycline [Imex®, tetra-cycline hydrochloride 3%, 20g] monotherapy in the treatment of mild to moderate acne vulgaris.
Methods: The sample group consisted of 87 volunteer students of both sexes with grade 1 to grade 2 acne as assessed by Investiga- tor’s Global Assessment (IGA) severity grading system. Subjects were instructed to apply topical tetracycline twice daily for 8 weeks. Subject were evaluated at baseline and at weeks 2, 4, and 8.
Results: Of 87 subjects, 68 completed the 8-week treatment period. The mean reduction rates of opened comedones were 55.4%, closed comedones were 27.1%, papules were 24.8 %, pustules were 27.3 %. After 8 weeks of treatment, a statistically significant reduction was only observed in the mean counts of the papules and pustules (P < 0.001).
Conclusion: Tetracycline is a well-tolerated topical agent and is particularly effective in the treatment of inflammatory lesions in acne.
Joseph Bikowski MD FAAD, James Q. Del Rosso DO FAOCD| |
Medication Choice and Associated Health Care Outcomes and Costs for Patients With Acne and Acne-Related Conditions in the United States
Palak Patel MS,a Hsien-Chang Lin PhD,b,c Steven R. Feldman MD PhD,d Alan B Fleischer Jr MD,d Milap C. Nahata MS PharmD,e Rajesh Balkrishnan PhDb,c| |
Background: Acne is a common condition for which multiple treatment options are available. The patterns of pharmacotherapy for
acne and similar conditions, and the effect of those patterns on cost, are not well characterized.
Objective: This study examined the impacts of patient demographics and medication choices on patients' health status and associated medication costs.
Methods: A retrospective cross-sectional study was conducted using the 2007 Medical Expenditure Panel Survey (MEPS) database. Information on patient demographics, health status, medication utilization and medication costs was obtained from the database representing 3,784,816 patients with acne and similar conditions.
Results: Weighted multiple linear regression analyses indicated that the use of topical retinoids was preferred in combination with other treatments rather than as monotherapy. Oral antibiotics were widely prescribed and their use was associated with a significant decrease in total annual prescription spending. Use of oral retinoids and oral contraceptives increased the annual prescription costs significantly. Increase in annual drug refills was not associated with the improvement in health status.
Conclusion: We observed an association with medication choice for acne and acne-related conditions on medication spending. Pharmacologic treatment of acne significantly adds to acne-related annual healthcare costs compared to non-pharmacologic treatment.
J Drugs Dermatol.2011;10(7):766-771.
Randomized, Double-Blind, Split-Face Study to Compare the Irritation Potential of Two Topical Acne Formulations Over a 21-Day Treatment Period
Leon H. Kircik MD,a Varsha Bhatt PhD,b Gina Martin MOT,b and Radhakrishnan Pillai PhDb| |
Recently, a new fixed combination product was introduced (clin 1.0%-BP 3.75% gel) that was shown to be effective in reducing both inflammatory and noninflammatory lesions in moderate to severe acne. Here, we assess the tolerability of clin 1.0%-BP 3.75% gel compared with adap 0.1%-BP 2.5% gel in healthy volunteers with no apparent facial redness or dryness over 21-days, using a split-face methodology.
Especially over the first two weeks of treatment, clin 1.0%-BP 3.75% gel was more tolerable than adap 0.1%-BP 2.5% gel, with statistically significant differences in cumulative change from baseline starting as early as day 8 (dryness) and day 9 (erythema), and composite index on days 8-12 and 16. Transepidermal water loss was less with clin 1.0%-BP 3.75% gel, although the difference was not statistically significant.
J Drugs Dermatol. 2016;15(2):178-182.
Doxycycline and Minocycline for the Management of Acne: A Review of Efficacy and Safety With Emphasis on Clinical Implications
Leon H. Kircik MD| |
Efficacy and Safety of Subantimicrobial Dose, Modified-Release Doxycycline 40 mg Versus Doxycycline 100 mg Versus Placebo for the treatment of Inflammatory Lesions in Moderate and Severe Acne: A Randomized, Double-Blinded, Controlled Study
Angela Moore MD,a Mark Ling MD,b Alicia Bucko MD,c Vasant Manna MD,d Marie-Jose Rueda MDe| |
METHODS: 662 subjects aged 12 years or older with moderate to severe acne received subantimicrobial, MR-DC 40 mg tablets, DC 100 mg capsules, or placebo once daily for 16 weeks.
RESULTS: MR-DC 40 mg was superior to placebo in the mean reduction of the number of inflammatory lesions, median percent reduction in inflammatory and total lesions, and success rate. MR-DC 40 mg was also comparable to DC 100 mg in the reduction of the number of inflammatory lesions, and percent reduction of total lesions. Incidence of drug-related AEs for MR-DC 40 mg was similar to placebo and was markedly smaller compared to DC 100 mg.
DISCUSSION: MR-DC 40 mg demonstrated comparable efficacy and superior safety to DC 100 mg in the treatment of moderate to severe inflammatory acne.
J Drugs Dermatol. 2015;14(6):581-586.
Advancement in Benzoyl Peroxide-Based Acne Treatment: Methods to Increase Both Efficacy and Tolerability
Tarek Fakhouri BS, Brad A. Yentzer MD, Steven R. Feldman MD PhD| |
Purpose: To review the literature for methods to increase the effi cacy and tolerability of benzoyl peroxide (BPO).
Methods: A PubMed literature search was done using the terms “benzoyl peroxide,” “vehicle,” “mechanism,” and “delivery system.” Relevant papers were reviewed for methods of increasing BPO effi cacy and tolerability.
Results: BPO in concentrations of 2.5%, 5% and 10% are equally effective at treating infl ammatory acne. However, higher concentrations are associated with more adverse effects. The effi cacy of BPO may be enhanced by the presence of Vitamin E and tertiary amines. BPO is also more effi cacious if used in combination with topical retinoids than as a monotherapy. Novel vehicles including a microparticle delivery system and those with a hydrophase or urea base increase the tolerability of BPO without sacrifi cing effi cacy.
Conclusion: Benzoyl peroxide has a proven track record of safety and effi cacy for the treatment of acne. Recent discoveries have provided new methods of increasing the effi cacy and tolerability of topical BPO, making it useful as monotherapy for mild acne or as an adjunct in the treatment of moderate to severe acne vulgaris.
Acne Vulgaris: The Role of Oxidative Stress and the Potential Therapeutic Value of Local and Systemic Antioxidants
J Drugs Dermatol. 2012;11(6):742-746
Cystic Acne Improved by Photodynamic Therapy with Short-Contact 5-Aminolevulinic Acid and Sequential Combination of Intense Pulsed Light and Blue Light Activation
Stuart Melnick MD| |
Trends in the Treatment of Acne Vulgaris: Are Measures Being Taken to Avoid Antimicrobial Resistance?
Megan A. Kinney MHAM BS,a Brad A. Yentzer MD,a Alan B. Fleischer Jr. MD,a Steven R. Feldman MD PhDa,b,c| |
Purpose: The aim of this study was to assess trends in prescribing antibiotics for acne from 1997−2006.
Methods: The authors examined the National Ambulatory Medical Care Survey (NAMCS) database and recorded medications at all visits to the physician in which acne vulgaris (ICD-9-CM code 706.1) was the only diagnosis from 1997−2006.
Results: Declines in the use of erythromycin and isotretinoin (both P<0.001) for acne were noted for all physicians. Tetracyclines saw significant increases in use by both dermatologists and non-dermatologists (P<0.01 and P=0.05, respectively). Prescribing of benzoyl peroxide monotherapy was unchanged for non-dermatologists (P=0.22) and is on the decline for dermatologists (P<0.001). The use of BPO + clindamycin combination topical treatments rose sharply for all physicians (P<0.001), resulting in greater use of both total BPO and total clindamycin for acne over time (P<0.001). Topical retinoid use increased among dermatologists (P<0.05) but appeared to be on the decline among non-dermatologists (P=0.067).
Conclusion: The development of antibiotic resistance is of concern. Greater awareness of retinoid use for maintenance therapy, using topical benzoyl peroxide to prevent resistance, and limiting use of oral antibiotics to as short a time period as possible are measures to contribute to better eco-responsible acne treatment.
Lucija Kroepfl MBChBa and Jason J. Emer MDb| |
Development of a New Patient-Reported Outcome Measure for Facial Acne: The Acne Symptom and Impact Scale (ASIS)
Andrew Alexis MD MPH,a Selena R. Daniels PharmD MS,b Nathan Johnson MPH,c*
Farrah Pompilus MA,d Somali Misra Burgess PhD,e* and Julie C. Harper MDf
METHODS: A literature and PRO review, patient interviews (concept elicitation), and input from clinical experts were used to develop a conceptual framework for the outcomes deemed important to facial acne patients, and to construct items for a preliminary PRO measure: the Acne Symptom and Impact Scale (ASIS). Cognitive interviews were conducted to pilot test the ASIS.
RESULTS: A review of the literature and PROs revealed that, of the 34 measures identified, no suitable PRO measure for the population of interest was available. The conceptual framework comprised two main themes: symptoms and psychosocial impacts. Concept elicitation interviews included a diverse set of patients (n=48) with facial acne, of various ages: 12-17 years (n=15), 18-25 years (n=20), and 26-50 years (n=13). The most frequently reported symptoms were: pimples, oily skin, scabs/scars/marks, blackheads, acne, and whiteheads. The most frequently reported impacts were impacts on appearance, self-consciousness, annoyance, bothersomeness, mood, social criticism, embarrassment, confidence, and social withdrawal. These reported symptoms and impacts constituted the 15-item draft ASIS. The draft ASIS was modified following the analysis of 20 cognitive interviews, resulting in the current 17-item ASIS.
CONCLUSIONS: Results from both the concept elicitation and cognitive interviews demonstrated that the ASIS is content valid in both adolescents and adults with facial acne. The ASIS will undergo psychometric evaluation to further support its validity in both adolescents and adults with facial acne.
J Drugs Dermatol. 2014;13(3):333-340.
Shaundre Terrell BS, Daniel Aires MD, Eric S. Schweiger MD| |
Observations: This article describes a 26-year-old African American woman with moderate infl ammatory facial acne vulgaris. On examination, she had over 15 infl ammatory papules on her face and post-infl ammatory hyperpigmentation. The patient had a history of treatment failure with the following therapies: topical benzoyl peroxide, topical antibiotics, topical retinoids and oral antibiotics. At presentation, the patient was using a combination topical benzoyl peroxide/clindamycin product in the morning and tazoratene gel in the evening without success. The patient was treated with 20% aminolevulinic acid/blue-light photodynamic therapy spaced monthly for a total of four treatments, a once-daily application of hydroquinone 4% cream and her existing topical regimen. The patient reported signifi cant improvement of infl ammatory acne lesions and post-infl ammatory hyperpigmentation following two treatments with photodynamic therapy and was virtually clear of all acne lesions after the third treatment.
Conclusion: Photodynamic therapy is an emerging remedy for patients with acne vulgaris resistant to standard treatment, particularly in patients with skin of color who are more sensitive to post-infl ammatory hyperpigmentation. In this African-American patient, 20% aminolevulinic acid/blue-light photodynamic therapy was effective in treating facial acne vulgaris.
Frequency of Treatment Switching for Spironolactone Compared to Oral Tetracycline-Class Antibiotics for Women With Acne: A Retrospective Cohort Study 2010-2016
John S. Barbieri MD MBA,a Juliana K. Choi MD PhD,a,b Nandita Mitra PhD,c David J. Margolis MD PhDa,c| |
Guy F. Webster MD PhD| |
J Drugs Dermatol. 2011;10(6):636-644.
Heather C. Woolery-Lloyd MD, Jonette Keri MD, and Stefan Doig MD| |
J Drugs Dermatol. 2013;12(4):434-437.
Omar A. Ibrahimi MD PhD,a Robert A. Weiss MD,b Margaret A. Weiss MD,b Christian R. Halvorson MD,b Flor Mayoral MD,c E. Victor Ross MD,d and Joel L. Cohen MDe| |
J Drugs Dermatol. 2015;14(9):1065-1068.
James Q. Del Rosso DO FAOCD| |
A New Approach to Comparing Efficacy Results from Clinical Trials of Topical Acne Vulgaris Treatments
Joseph Bikowski MD FAAD| |
Gholamhosein Ghaffarpour MD, Shadi Mazloomi MD, Razieh Soltani-Arabshahi MD, Seyed Kamran Soltani Arabshahi MD| |
Jonathan S. Weiss MD| |
J Drugs Dermatol. 2013;12(suppl 6):s70-s72.
Mark S. Nestor MD PhD (chair), Michael H. Gold MD (co-chair), Arielle N. B. Kauvar MD, Amy F. Taub MD, Roy G. Geronemus MD, Eva C. Ritvo MD, Dore J. Gilbert MD, Mitchel P. Goldman MD, Donald F. Richey MD| |
A Single-Center, Randomized Double-Blind, Parallel-Group Study to Examine the Safety and Efficacy of 3mg Drospirenone/0.02mg Ethinyl Estradiol Compared With Placebo in the Treatment of Moderate Truncal Acne Vulgaris
Ma. Beatrice Alora Palli MD,a,b Claire Marie Reyes-Habito MD,b Xinaida T. Lima MD MPH,c and Alexa B. Kimball MD MPHa,b| |
OBJECTIVE: In this study, we sought to evaluate the safety and efficacy of 3mg DRSP/0.02mg EE versus placebo in the treatment of truncal acne in women.
METHODS: Females, age 18-45, with 10 to 50 truncal acne lesions, were randomized in this double-blind study to 3mg DRSP/0.02mg EE (n=15) or placebo (n=10) administered in a 24/4 regimen given for 24 weeks. Noninflammatory, inflammatory and total truncal acne lesion counts were assessed from baseline to endpoint and mean percent change compared. Investigator Global Assessment (IGA) and Subject Global Assessment (SGA) were assessed based on scoring scales, and the percentage of subjects rated as success with clear (score 0) or almost clear (score 1) were computed.
RESULTS: The 3mg DRSP/0.02mg EE group had significant reductions in mean percent change in noninflammatory, inflammatory and total lesions by 52.1%, 53.2%, and 57.3%, respectively, compared to placebo with -9.2%, 18.2% and 17.0 %, respectively, by week 24 (p = 0.02, 0.05 and 0.02, respectively). The percentage of subjects on 3mg DRSP/ 0.02mg EE rated as treatment success were 53.3% and 60% based on IGA and SGA respectively. The regimen was also well tolerated by patients.
CONCLUSIONS: 3mg DRSP/ 0.02 mg EE is a safe and significantly effective treatment for moderate truncal acne.
J Drugs Dermatol. 2013;12(6):633-637.
Tretinoin Gel Microsphere Pump 0.04% Plus 5% Benzoyl Peroxide Wash for Treatment of Acne Vulgaris: Morning/Morning Regimen Is as Effective and Safe as Morning/Evening Regimen
David Pariser MD, Alicia Bucko DO JD, Richard Fried MD PhD, Michael T. Jarratt MD, Steven Kempers MD, Leon Kircik MD, Anne W. Lucky MD, Elyse Rafal MD, Marta Rendon MD Jonathan Weiss MD, David C. Wilson MD, Ana Beatris Rossi MD, Ratna Ramaswamy PhD, Marge Nighland BS| |
Pilot Randomized-Control Trial to Assess the Effect Product Sampling has on Adherence Using Adapalene/Benzoyl Peroxide Gel in Acne Patients
Laura F. Sandoval DO,a Ashley Semble MS,a Cheryl J. Gustafson MD,a Karen E. Huang MS,a Michelle M. Levender MD,a and Steven R. Feldman MD PhDa,b,c| |
PURPOSE: To determine whether demonstrating to patients how to properly apply a topical acne medication through the use of a sample product will improve adherence.
METHODS: Subjects with mild to moderate acne were instructed to use adapalene/benzoyl peroxide gel once daily for six weeks. Subjects were randomized into sample or no sample group. Sample group received a demonstration on how to apply the medication using a product sample. The primary outcome was median adherence, recorded using electronic monitoring, and secondary outcomes were efficacy measures including the Acne Global Assessment (AGA) and lesion counts and the Perceived Medical Condition Self-Management Scale (PMCSMS).
RESULTS: Data from 17 patients was collected and analyzed. Median adherence rates were 50% in the sample group and 35% in the no sample group (p=0.67). The median percent improvement in non-inflammatory lesions were 46% for the sample group and 33% for the no-sample group (p=0.10).
LIMITATIONS: The small size of this pilot study limited the extent of subgroup analyses.
CONCLUSIONS: Objective electronic monitoring expanded our previous observations of poor adherence in the treatment of acne. There is a considerable potential effect size on adherence for the use of samples, supporting the need for future, well powered studies to assess the value of using samples in the treatment of acne and other dermatologic skin diseases.
J Drugs Dermatol. 2014;13(2):135-140.
Rachel E. Epstein DO and James Spencer MD MS| |
The Efficacy, Safety, and Tolerability of Adapalene Versus Benzoyl Peroxide in the Treatment of Mild Acne Vulgaris: A Randomized Trial
S.H. Babaeinejad MD and R.F. Fouladi MD| |
J Drugs Dermatol. 2013;12(7):790-794.
Sindy Hu MD MS and Michael H. Gold MD| |
The Efficacy, Safety and Tolerability of Adapalene Versus Benzoyl Peroxide in the Treatment of Mild Acne Vulgaris; A Randomized Trial
S.H. Babaeinejad MD and R.F. Fouladi MD| |
J Drugs Dermatol. 2013;12(9):1033-1038.
Efficacy, Safety, and Tolerability of Topical Dapsone Gel, 7.5% for Treatment of Acne Vulgaris by Fitzpatrick Skin Phototype
Susan C. Taylor MD,a Fran E. Cook-Bolden MD,b Amy McMichael MD,c Jeanine B. Downie MD,d David A. Rodriguez MD,e Andrew F. Alexis MD MPH,f Valerie D. Callender MD,g and Nancy Alvandi PhDh| |
Stratum Corneum Abnormalities and Disease-Affected Skin: Strategies for Successful Outcomes in Inflammatory Acne
Laura Jordan DO MS and Hilary E. Baldwin MD b| |
J Drugs Dermatol. 2016;15(10):1170-1173.
Habib Ansarin MD, Sayied Savabynasab MD,Ashkan Heshmatzade Behzadi MD, Nader Sadigh MD,Jaleh Hasanloo MD| |
Objective: The goal of this study was to determine the efficacy of levamisole in addition to doxycycline in the treatment of patients suffering from severe nodulocystic acne.
Methods: A double-blind, randomized, placebo-controlled trial was conducted in the dermatology clinic of Rasoul-e-Akram Hospital in Tehran, Iran in 2006. Sixty patients were randomly assigned to 1 of 2 study groups. The case group was administered oral levamisole 2.5 mg/kg/wk (up to 150 mg/wk) plus doxycycline 100 mg daily and the control group was given 100 mg of oral doxycycline daily and a placebo. Patients were evaluated at baseline, and at 2-month, 4-month, and 6-month checkpoints.
Results: The responses to treatment were significantly higher in the case group according to the reduction in total lesions count, acne severity index; and papule/pustule and nodule/cyst count at the 2nd, 3rd, and 4th visits.
Conclusion: Results indicated that adding oral levamisole to doxycycline is an effective treatment for severe nonresponsiveness to conventional treatments of acne vulgaris. In the patient group, levamisole was well tolerated with an acceptable safety profile. At the time of publication, this study is the first clinical trial that suggests levamisole as an effective new treatment for severe acne vulgaris.
Long-Term Safety and Efficacy of a Unique Fixed-Dose Combination Gel of Adapalene 0.1% and Benzoyl Peroxide 2.5% for the Treatment of Acne Vulgaris
David M. Pariser MD, Patricia Westmoreland MD, Amy Morris MD, Michael H. Gold MD, Yin Liu PhD, Michael Graeber MD| |
Shivani S. Patel BS,a Karen E. Huang MS,a Alan B. Fleischer Jr. MD,a and Steven R. Feldman MD PhDa,b,c| |
METHODS: We conducted a query of ClinicalTrials.gov for dermatologic clinical trials from 2009 to 2013 for 6 common skin conditions: acne, psoriasis, rosacea, eczema and atopic dermatitis, actinic keratosis, and skin cancer. Results were sorted by condition and number of study subjects. This study did not involve any participants apart from the researchers.
RESULTS: Although there is an increasing trend in the number of trials performed annually, the results were not significant (P=.08). The average number of patients per study has not significantly changed (P=.12), but there was a significant increase in the number of large studies (201+ subjects) conducted over time (P=.002). Although there was significant variation based on dermatologic condition studied (global statistic P=.01), only skin cancer demonstrated a significant change in the number of studies registered annually (β=10.6 studies/year, P=.04).
CONCLUSIONS AND RELEVANCE: The sky does not appear to be falling, at least not yet, with regard to continued development of treatments for patients with skin disease.
J Drugs Dermatol. 2015;14(5):497-500.
Linda Stein Gold MD| |
J Drugs Dermatol. 2015;14(6):567-572.
Randomized Comparison of the Safety and Efficacy of Tazarotene 0.1% Cream andAdapalene 0.3% Gel in the Treatment of Patients With at Least Moderate FacialAcne Vulgaris
Emil Tanghetti MD, Sunil Dhawan MD, Lawrence Green MD, James Del Rosso DO, Zoe Draelos MD,James Leyden MD, Alan Shalita MD, Dee Anna Glaser MD, Pearl Grimes MD, Guy Webster MD PhD,Pamela Barnett BS, Nicolas Le Gall MSc| |
The Efficacy and Tolerability of a Fixed Combination Clindamycin (1.2%) and Benzoyl Peroxide (3.75%) Aqueous Gel in Patients With Facial Acne Vulgaris: Gender as a Clinically Relevant Outcome Variable
Julie C. Harper MD| |
METHODS: A post hoc analysis comparing the efficacy and cutaneous tolerability in 498 male and female patients with moderate to severe acne receiving clindamycin phosphate 1.2%/BP 3.75% gel, or vehicle for 12 weeks.
RESULTS: The efficacy of clindamycin phosphate 1.2%/BP 3.75% gel was greater than vehicle (P>.001) in both genders. Within the clindamycin phosphate 1.2%/BP 3.75% gel group, the mean percent change from baseline in inflammatory and noninflammatory lesion counts was greater among females than males, as was the percentage of subjects who achieved a 2-grade reduction in the EGSS (P=.049).
LIMITATIONS: It is not possible to determine the contributions of the individual active ingredients.
CONCLUSIONS: Clindamycin phosphate 1.2%/BP 3.75% gel provides statistically significant greater efficacy than vehicle with a favorable safety and tolerability profile. It appears to be more effective in female patients.
J Drugs Dermatol. 2015;14(4):381-384.
Linda Stein Gold MD,a William P. Werschler MD,b Jennifer Mohawk PhDc| |
BACKGROUND: Acne vulgaris affects a diverse group of people, and there is an increasingly wide variety of acne treatments. Because of the many options, clinicians have a better ability to individualize treatment; however, achieving optimal results relies on understanding how various agents perform in specific population segments. Fixed-combination adapalene plus benzoyl peroxide (A/BPO) is a first-line recommended acne therapy and is available in two adapalene concentrations (0.1% and 0.3%) combined with BPO 2.5%. This analysis investigated whether gender and age have an impact on either the efficacy or safety of topical A/BPO 0.3%.
METHODS: A post-hoc subanalysis was performed on data from a multicenter, randomized, double-blind, parallelgroup, 12-week study of A/BPO gel 0.3%/2.5% or vehicle gel in subjects ≥ 12 years old with moderate to severe acne vulgaris (Investigator global assessment [IGA] of 3 or 4). Efficacy measurements included achievement of an IGA of clear (0) or almost clear (1), and change in lesion counts from baseline to week 12. Safety measures included adverse events and cutaneous tolerability. The intent to treat (ITT) and safety populations were analyzed.
RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 217 subjects. Among the subjects, 111 were 12-17 years old and 106 were ≥ 18 years old; 104 were male and 113 were female. A/BPO 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle in success rates (IGA 0 or 1) and reduction of inflammatory/noninflammatory lesions (P≤0.05) across both age groups and genders.
CONCLUSIONS: A/BPO 0.3%/2.5% treatment achieved success and was equally effective and safe in younger vs older subjects and in males vs females. These results support the use of A/BPO 0.3%/2.5% in all subjects 12 and older.
Clinicaltrials.gov registry: (NCT01880320)
J Drugs Dermatol. 2017;16(6):582-589.
An Open Label, Phase 2 Study of MABp1 Monotherapy for the Treatment of Acne Vulgaris and Psychiatric Comorbidity
Daniel Carrasco MD,a Michael Stecher MD,b Gigi Claire Lefebvre MD,c Alan C. Logan ND,d Ronald Moy MDe| |
OBJECTIVE: To assess the efficacy of interleukin 1 alpha blockade in patients with moderate to severe acne vulgaris using the true human monoclonal antibody MABp1.
METHODS: Eleven patients were administered open-label, subcutaneous injections of MABp1 over a six-week period. Objectives were assessment of safety, change in inflammatory lesion count and change in psychosocial functioning using two validated questionnaires.
RESULTS: There were no serious adverse events, or adverse events greater than grade I. Median inflammatory lesion counts decreased 36% (IQR -44% to 1%). Anxiety scores improved (from median 6 to 1) as well as self-image assessment (2.3±0.9 to 2.1±0.1) as measured by the Hospital Anxiety and Depression Scale and the modified Body Image Disturbance Questionnaire.
CONCLUSION: Patients had rapid improvement of skin lesions, as well as psychosocial functioning and anxiety. MABp1 may provide a safe and effective means for treating inflammatory acne lesions and. Further studies using this antibody are warranted in this patient population.
J Drugs Dermatol. 2015;14(6):560-564.
Validation of a New Patient-Reported Outcome Measure for Facial Acne: The Acne Symptom and Impact Scale (ASIS)
Stacie Hudgens MA,a* Julie C. Harper MD,b Selena R. Daniels MS,c Benjamin Banderas,d Sepideh Varon,c and Andrew F. Alexis MD MPHf| |
METHODS: Psychometric evaluation was performed using both traditional psychometrics in line with proposed US Food and Drug Administration (FDA) criteria and new psychometric methods, Rasch Measurement Theory (RMT). Assessment of equivalence was also evaluated between Caucasians and Non-Caucasians on individual items.
RESULTS: One-hundred fifty subjects completed baseline and follow-up assessments (89 [59.33%] in the Caucasian group and 61 [40.67%] in the Non-Caucasian group). Psychometric analyses demonstrated that the ASIS Sign and Impact domains both performed well. Each domain fulfilled traditional psychometric criteria (Cronbach’s alpha=0.79-0.92; test-retest reliability=0.75-0.78) and mostly satisfied Rasch psychometric criteria (person-reliability=0.72-0.93; person-separation=1.61-3.69). Select individual ASIS Items also performed well across all measures and were shown to be reliable and valid as stand-alone items. A similar pattern of results were found for both Caucasian and Non-Caucasian racial subgroups.
CONCLUSIONS: These findings provide empirical evidence that the ASIS is a reliable and valid PRO measure that can accurately assess the severity of symptoms and impacts associated with acne vulgaris.
J Drugs Dermatol. 2015;14(6):552-559.
Safety and Efficacy of Two Anti-Acne/Anti-Aging Treatments in Subjects With Photodamaged Skin and Mild to Moderate Acne Vulgaris
Background: Although reliable prevalence data are not available, adult acne is thought to be somewhat common, and it is not unusual for patients
to have acne as well as early signs of skin aging. A novel anti-acne/anti-aging formulation (Treatment A) has been developed for daily use by
patients to address both signs of skin aging and facial acne vulgaris. The novel, non-prescription formulation includes several ingredients shown
to target factors underlying the pathogenesis of acne vulgaris while also addressing multiple components in the pathophysiology of skin aging.
Methods: A blinded, randomized, split-face study was conducted to evaluate and compare the tolerability and efficacy of the novel anti-acne/ anti-aging product in subjects with photodamaged skin and acne vulgaris relative to tretinoin cream 0.025% (Treatment B). All subjects also were given supportive skincare, consisting of a cleanser, moisturizer, and sunscreen. Each treatment was assessed for its effects on subjects' appearance, lesion count reductions, and tolerability.
Results: Treatment A produced statistically significantly greater improvements in skin tone evenness, skin tone clarity, and blemishes and blotchiness. There were also statistically greater reductions in total lesion count for acne patients on the side of the face treated with Treatment A compared to Treatment B; Treatment A was also associated with early (day 2) improvement in skin tone evenness and clarity, tactile skin smoothness, and blemishes and blotchiness. Both treatments demonstrated favorable tolerability.
Conclusion: The novel topical anti-aging/anti-acne therapy (Treatment A) within a comprehensive skin care regimen of cleanser, moisturizer, and sunscreen may maximize efficacy and tolerability and contribute to our armamentarium for treating both photodamage and acne at the same time.
J Drugs Dermatol. 2012;11(6):737-740
Nevien A. Sami PhD, Abeer T. Attia PhD, Ashraf M. Badawi| |
Objectives: To evaluate the effectiveness of pulsed dye laser (PDL), intense pulsed light (IPL) and light-emitting diode (LED) phototherapy for the treatment of moderate to severe acne vulgaris.
Methods: Forty-five patients with moderate to severe acne were randomly divided into 3 equal groups. Group 1 was treated with a PDL, group 2 was treated with IPL, and group 3 was treated with a blue-red combination LED. Treatment was continued until a ≥90% clearance of patient lesions was achieved. Clinical assessments were conducted before starting treatment, at 1 month as a midpoint evaluation, and after the final treatment session.
Results: Patients treated with the PDL reached a ≥90% clearance of their inflammatory lesions after a mean of 4.1±1.39 sessions, while patients treated with IPL required a mean of 6±2.05 sessions. Patients treated with the LED required a mean of 10±3.34 sessions. At the mid-point evaluation, the percent reduction in acne lesions treated with the PDL was 90% or more, in cases of IPL and the LED, the percent reductions were 41.7% and 35.3%, respectively. Laser and light phototherapy sessions were well tolerated with minimal adverse events experienced as being mild and usually self-limiting.
Conclusions: The encouraging results of the present study contributes evidence of phototherapy as useful therapeutic option for treatment of moderate to severe acne, and validates further studies to evaluate treatments with a larger number of patients and for a longer period of follow-up.
Maha Fadel PhD, Manal Salah MD, Nevien Samy PhD, Mona Soliman MD| |
Objectives: To evaluate the efficacy and tolerability of liposomes loaded methylene blue (LMB) based photodynamic therapy in patients with mild-to-moderate acne vulgaris in a randomized, controlled and investigator blinded study.
Materials and methods: Liposomes loaded methylene blue (LMB) was prepared and studied for different pharmaceutical properties and formulated in hydrogel (MB 0.1%). Permeability and selective sebaceous gland targeting in mice skin was studied. Gel containing LMB was used for treating 13 patients complaining of mild-moderate acne vulgaris once a week for two weeks. Efficacy evaluation included changes in lesions counts, clinical assessments of clinical improvement by patients and evaluating dermatologists. Pain and local adverse effects were also evaluated.
Results: The mechanism of the drug released from liposomes (both in pH=5.5 and in pH=7.2) was following zero order kinetics with significant increase in the drug released in pH=5.5. Drug released from free methylene blue (FMB) gel was significantly higher (P≤0.05) with Higuichi’s diffusion model than LMB gel, which followed zero order kinetics. Free MB gel showed superficial destruction in the mice hair shaft while LMB showed complete destruction of pilosebaceous unit. After only two sessions, there was a 83.3% reduction in the number of inflammatory acne lesions and a 63.6% reduction in the number of non-inflammatory acne lesions. At 12 weeks, 90% of patients had a moderate-to-marked improvement of their acne in the treated areas. Most patients had no pain; also no serious adverse side effects were recorded. All the patients had no edema. Slight transient hyperpigmentation was seen only in three patients.
Conclusion: Liposomal MB hydrogel selectively delivered MB to sebaceous gland and was effective in photodynamic treatment of mild-to-moderate acne vulgaris.
Steven R. Feldman MD PhD, Linda H. Stein Gold MD, Joshua A. Zeichner MD| |
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 2 AMA PRA Category 1 Credits.
Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Assessment of Efficacy and Safety in Patients Aged 9 Years and Older
Stephen K. Tyring MD PhD,a Leon H. Kircik MD,b David M. Pariser MD,c Eric Guenin PharmD PhD,d Varsha Bhatt PhD,e Radhakrishnan Pillai PhDe| |
Michael H. Gold MD, Julie Biron BS| |
Objective: The objective of this study was to evaluate the safety and efficacy of photopneumatic technology for the treatment of mild to moderate acne vulgaris.
Methods: Eleven subjects (7 women) aged 15 to 54 years with skin types 1 to 4 presented with mild to moderate facial acne (defined as 15 or more facial inflammatory or noninflammatory lesions) were recruited to the study. All subjects underwent 4 photopneumatic treatments at 3-week intervals with follow-up visits at 1 and 3 months.
Results: Inflammatory lesion counts continued to decrease for at least 3 months after the final treatment. At 3 months, reductions in lesion counts were significant for both inflammatory (P=.0137) and noninflammatory (P=.0383) lesions. Mean scores between visits consistently dropped sharply from their immediate posttreatment values for pain, erythema, and edema. Nine subjects (82%) were moderately satisfied to very satisfied with treatment.
Conclusion: Results suggest that the photopneumatic device is a safe and effective modality for the treatment of mild to moderate inflammatory and comedonal acne vulgaris.
Erin Lessner MD,a Samantha Fisher MD,b Katherina Kobraei MD,b Michael Osleber MD,b Rebecca Lessner BS,c Lauren Elliott MD,d and Stanton Wesson MDb| |
METHODS: A retrospective chart review on 41 female patients age 19-57 years old with cyclical acne was performed. Patients were examined over the course of 2 to 102 months while taking 50 to 200mg of spironolactone and topical tretinoin 0.025% or adapalene 0.1% cream. All were diagnosed with acne rated mild to severe, prior to treatment, and were started on an initial dose of 50mg po daily. If significant improvement was not seen within the first 3-6 months, the dose was either held or increased in 25mg increments every 3 months. Patients on oral and topical antibiotics, as well as patients on photodynamic therapy were excluded from the study. The response to treatment was rated on a 0-4 scale with 0 being no response and 4 corresponding to clear skin.
RESULTS: One patient (2.4%) had no response to treatment. This patient was only on 50mg po daily for only 2 months. Only 5 (12.2%) patients had minimal response to treatment and 9 (22.0%), 12 (29.3%), and 14 (34.1%) had a good, excellent, or clear response respectively. The study showed 26 (63.4%) women on treatment with spironolactone and topical retinoids had an excellent or clear outcome, and 35 (85.4%) were considered to have a good, excellent, or clear response.
CONCLUSION: The addition of spironolactone to topical retinoid treatment suggests a superior response to retinoids alone in clearance of female adult cyclical acne.
J Drugs Dermatol. 2014;13(2):126-129.
Accelerated Onset of Action and Increased Tolerability in Treating Acne With a Fixed-Dose Combination Gel
Adam Friedman MD,a Kim Waite BSc,b Staci Brandt PA-C MBA MSMR, c and Matthew H. Meckfessel PhDb| |
J Drugs Dermatol. 2016;15(2):231-236.
Ava T. Shamban MD, Mikiko Enokibori MD, Vic Narurkar MD, Donna Wilson RN| |
Methods: In a retrospective multicenter study, clinical data were collected from 56 patients with mild to severe acne. Patients had been treated 2 to 4 times with a portable photopneumatic device (Aesthera PPx, Aesthera Corporation, Pleasanton, CA) that delivers broadband light (400 to 1200 nm) to the treatment site via a hand piece. For 11 of the 56 photographs taken before and after PPx treatment.
Results: For the 56 patients, the median physician-rated clearance increased from 50% after a single treatment to 90% after the fourth treatment, whereas the median patient-rated clearance improved form 50% after a single treatment to 78% after the fourth treatment. On a 4-point scale, both physician-rated and patient-rated median overall satisfaction levels increased from a 3 after a single treatment, to 4 after the second, third, and fourth treatments. Clinically significant adverse events were not observed. For the 11 patients evaluated by photography, the median papule and pustule lesion counts decreased from 2 to 0, respectively. Median acne severity (Burton scale) decreased from 2 before treatment to 1 after the final treatment (scale 1-4). Adverse events were limited to mild erythema.
Conclusion: Photopneumatic technology provides a safe and effective treatment of mild to sever acne vulgaris.
James M. Swinehart MD| |
A 2940 nm Fractional Photothermolysis Laser in the Treatment of Acne Scarring: A Pilot Study in China
Hui Deng MD PhD, Dingfen Yuan MD, Chunlin Yan MD, Xiaoxi Lin MD PhD, Xu’an Ding MD| |
Methods: Twenty-six patients with moderate-to-severe atrophic scarring were treated with a 2940 nm-wavelength fractional photothermolysis laser.
Results: All patients had encouraging results. Both skin elasticity and moisture content increased significantly after five treatments. In post-treatment evaluations, both the patients treated, as well as an independent group of physicians each scored the atrophic scar improvement as significant.
Conclusion: The 2940 nm fractional photothermolysis laser is safe and effective in the treatment of acne scarring.
A Randomized, Phase 2, Dose-Ranging Study in the Treatment of Moderate to Severe Inflammatory Facial Acne Vulgaris With Doxycycline Calcium
James J. Leyden MD,a Suzanne Bruce MD,b Chai Sue Lee MD,c,* Mark Ling MD PhD,d Pranav B. Sheth MD,e Daniel M. Stewart DO,f William P. Werschler MD,g Richard D. Gilbert PhD,h and Leon Kircik MDi| |
METHODS: This was a randomized, double-blind, phase 2 dose-ranging study in subjects with moderate to severe inflammatory acne aged 12 years to 45 years. Subjects were randomized to receive doxycycline calcium tablets 0.6, 1.2, or 2.4 mg/kg/day or placebo, and instructed to take their tablets once daily for 12 weeks, in the evening at least 1 hour before or 2 hours after mealtime. The primary efficacy variables were the dichotomized Investigator's Global Assessment score (success or failure) at week 12 (success defined as ≥2 score decrease from baseline) and the absolute change from baseline to week 12 in inflammatory lesion count.
RESULTS: A dose-response effect was seen with doxycycline calcium formulation in subjects with moderate to severe inflammatory acne. The highest dose-group (corresponding to approximately 2.4 mg/kg/day) showed a statistically significant difference from placebo. The dose-response effect was confirmed by logistic regression analysis for both treatment success and incidence of gastrointestinal adverse events. A limitation of this study is that safety and efficacy were only studied on moderate to severe inflammatory acne. Also, the study was not prospectively powered to show efficacy differences.
CONCLUSION: Doxycycline calcium shows a dose-response effect in reducing inflammatory lesions in subjects with moderate to severe inflammatory acne.
J Drugs Dermatol. 2013;12(6):658-663.
Deganit Barak-Shinar PhDa and Zoe Diana Draelos MDb| |
OBJECTIVE: The study evaluated the tolerability and efficacy of a new presented treatment for acne. The product is an OTC topical gel consisting of 2% SA, which is also enriched in botanicals that have been shown to have anti-inflammatory properties.
DESIGN: The study was designed as a single-site, randomized, investigator-blinded, split-face 10-day study.
SETTING: Subjects enrolled with a minimum of 2 inflammatory papular acne lesions and 2 non-inflammatory open or closed comedones on both sides of the face in symmetrical locations, to the greatest degree possible. One side of each subject’s face was randomly selected to receive the study treatment product.
PARTICIPANTS: 25 subjects, 15 female and 10 males, ages 12 to 43 years, suffering from mild to moderate acne.
Measurements: Study duration was 10 days, with study visits occurring at baseline (day 0), day 1, day 2, day 3, day 7, and day 10. Subjects underwent investigator facial evaluation and lesion assessment by dermatologist at each of the visit days. For the inflammatory lesions, the assessed parameters were erythema, elevation, induration, and overall impression. The assessed non-inflammatory parameters were elevation and overall impression.
Results: The observed difference between the treatment and the control group increased between day 1 and day 2 and reached an average of 15% to 20% with small varieties between the parameters and stayed similar across the remaining visits. Statistically significance (P less than 0.005) was achieved for all inflammatory and non-inflammatory tested parameters.
Conclusion: This study was performed to determine the safety, efficacy, and ease of use of a botanical acne treatment gel in providing a reduction in inflammatory acne lesion erythema, elevation, and induration. Erythema and elevation were the most influential parameters in inflammatory lesion with improvement noted after 2 days of application.
J Drugs Dermatol. 2017;16(6):599-603.
Neil S. Sadick MD| |
Treatment of Moderate Acne Vulgaris in Fitzpatrick Skin Type V or VI: Efficacy and Tolerability of Fixed Combination Clindamycin Phosphate 1.2%/Benzoyl Peroxide 3.75% Gel
Laetitia Amar and Leon H. Kircik MD| |
Integrated Cooling-Vacuum-Assisted Non-Fractional 1540 nm Erbium:Glass Laser is Effective in Treating Acne Scars
Yael Politi MD,a Assi Levi MD,b,c and Moshe Lapidoth MDa,b,c| |
Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: Second of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-Controlled Trials
Lawrence F. Eichenfield MD,a Ted Lain MD,b Ellen H. Frankel MD,c Terry M. Jones MD,d Joan-En Chang-Lin PhD,e David R. Berk MD,e Shiling Ruan PhD,e and Alexandre Kaoukhov MDe| |
OBJECTIVE: The study objective was to assess the efficacy and safety, compared with vehicle, of acne treatment with a recently FDA-approved, once-daily formulation of dapsone gel, 7.5%, with a 50% greater concentration of dapsone.
METHODS: This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients aged 12 years and older with 20–50 facial inflammatory lesions, 30–100 facial noninflammatory lesions, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized (1:1 ratio) to topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with a GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.
RESULTS: The intent-to-treat population comprised 2238 patients (1118 in the dapsone gel, 7.5% group and 1120 in the vehicle group). The GAAS success rates were 29.8% for the dapsone gel, 7.5% group and 20.9% for the vehicle group (P<0.001) at week 12. At week 12, mean inflammatory lesions decreased from baseline by 53.8% and 47.3%, noninflammatory lesions decreased by 45.9% and 40.4%, and total lesions decreased by 48.9% and 43.2% for the dapsone gel, 7.5% group and the vehicle group, respectively (all, P<0.001). The incidence of treatment-emergent adverse events was similar for dapsone gel, 7.5% (17.6%) and vehicle (17.1%). Most adverse events were mild to moderate in severity. The most frequently reported increase in severity for all of the dermal tolerability scales was from “none” to “mild.”
CONCLUSION: Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne vulgaris. Improvements in acne severity and lesions were observed over the 12-week course of treatment.
J Drugs Dermatol. 2016;15(8):962-969.
Jeffrey M. Weinberg MD| |
Benzoyl peroxide in hydrophase base (Brevoxyl® Creamy Washes and Gels) has shown significant efficacy in the treatment of acne, with lower irritancy than other benzoyl peroxide preparations. It is felt that the low irritancy of this product is related to a unique delivery vehicle containing dimethyl isosorbide, which dissolves benzoyl peroxide crystals on the skin. Clinical studies demonstrating the efficacy and safety of benzoyl peroxide in hydrophase base will be reviewed.
Steven R. Feldman MD PhDa and Diana M. Chen MDb| |
Background: Products that may cause irritation are widely used to treat acne. Irritation has the potential to reduce treatment adherence.
How patients manage irritation and dryness is not well characterized.
Objectives: To study self-reported irritation, its impact and coping mechanisms in patients who had been treated for acne with a clindamycin-5% benzoyl peroxide (BPO) product.
Methods: An Internet-based survey of 200 subjects, aged 15-40 years who had used a clindamycin-5% BPO fixed combination product in the last six months on at least 50 percent of their face, at least five days per week.
Results: The majority of subjects (57%) had moderate acne, 28 percent had severe acne. Bothersome side effects of the clindamycin- 5% BPO combination included dry skin (55%), flaky/peeling skin (45%), irritated skin (44%), itchy skin (39%) and redness (37%). As a result, subjects used the product only as a spot treatment (33%), only when breakouts seemed worse (28%), or less often than recommended (32%); stopped using from time to time (32%); switched to a different prescription medication and/or an over-thecounter acne product (28%); or stopped using altogether (10%). 41 percent of subjects reported using moisturizers to counteract dryness and redness.
Limitations: We queried patients concerning use of combination clindamycin/BPO products and not other products.
Discussion: Irritation to clindamycin-5% BPO is a common problem that reduces patients' use of the medication. Strategies to improve treatment include communication with patients on possible side effects, providing written instruction on how to manage irritation and dryness and consideration of alternative topical treatments and treatment regimens.
J Drugs Dermatol. 2011;10(6):605-608.
Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: First of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-controlled Trials
Linda F. Stein Gold MD,a Michael T. Jarratt MD,b Alicia D. Bucko DO,c Steven K. Grekin DO,d
Joshua M. Berlin MD,e Michael Bukhalo MD,f Jonathan S. Weiss MD,g David R. Berk MD,h
Joan–En Chang–Lin PhD,h Vince Lin PhD,h and Alexandre Kaoukhov MDh
OBJECTIVE: The objective of this study was to assess the efficacy and safety of a new, once-daily formulation of dapsone gel, 7.5%, with a 50% higher dapsone concentration, versus vehicle over 12 weeks in patients with acne.
METHODS: This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients with moderate acne aged 12 years and older with 20 to 50 inflammatory lesions and 30 to 100 noninflammatory lesions on the face, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized to receive topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.
RESULTS: The intent-to-treat population comprised 2102 patients, 1044 in the dapsone gel, 7.5% group and 1058 in the vehicle group. At week 12, 29.9% of patients in the dapsone gel, 7.5% group and 21.2% in the vehicle group (P<.001) had GAAS success. Mean inflammatory lesions decreased by 55.5% and 49.0%, noninflammatory lesions decreased by 44.4% and 38.4%, and total lesions decreased by 48.7% and 42.4% in the dapsone gel, 7.5% and vehicle groups (all P<.001), respectively, at week 12. The incidence of adverse events was similar in the dapsone gel, 7.5% (19.1%) and vehicle (20.6%) groups. Most events in both groups were mild or moderate in severity. Most patients receiving dapsone gel, 7.5% and vehicle had a severity rating of “none” for stinging/burning, dryness, scaling, and erythema scales at all time points.
CONCLUSIONS: Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne.
J Drugs Dermatol. 2016;15(5):553-561.
Alan R. Shalita MD,a Ronald Falcon MD,b Alan Olansky MD,c Patricia Iannotta MD,d Arash Akhavan MD,e Doris Day MD,f, Anthony Janiga MD,g Prashant Singri MD,h and John E. Kallal PhDi| |
Objective: To assess the usefulness of a novel dietary supplement in the overall management of patients with inflammatory acne vulgaris.
Methods: 235 patients with inflammatory acne vulgaris were enrolled by dermatologists in a multicenter, open-label, 8-week, prospective study evaluating the effects of adding NicAzel, 1 to 4 tablets daily, to their current acne treatment regimen.
Results: A statistically significant (P<.0001) number of patients demonstrated improvement over their previous acne treatment regimens after both 4 and 8 weeks of NicAzel (nicotinamide, azelaic acid, zinc, pyridoxine, copper, folic acid; Elorac Inc, Vernon Hills, IL) use. At week 8, 88% of the patients experienced a visible reduction in inflammatory lesions, and 81% of the patients rated their appearance as much or moderately better compared with baseline. Three-quarters (76%) of the patients thought NicAzel was at least as effective as previous treatment with oral antibiotics.
Conclusion: Patients with inflammatory acne showed significant improvement in acne severity and overall appearance when NicAzel was added to their existing treatment regimen.
J Drugs Dermatol. 2012;11(12):1428-1433.
Clinical Evidence for the Role of a Topical Anti-Inflammatory Agent in Comedonal Acne: Findings From a Randomized Study of Dapsone Gel 5% in Combination With Tazarotene Cream 0.1% in Patients With Acne Vulgaris
Emil Tanghetti MD,a Sunil Dhawan MD,b Lawrence Green MD,c Mark Ling MD PhD,d Jeanine Downie MD,e Marguerite A. Germain MD,f J. Scott Kasteler MD,g Leon Kircik MD,h Michael G. Oefelein MD,i Zoe Draelos MDj| |
Background: Acne pathogenesis is multifactorial and includes inflammation. Combining drugs targeting multiple components of
acne pathogenesis is standard practice.
Objective: To assess the safety and efficacy of dapsone gel 5%, an anti-inflammatory agent, in combination with tazarotene cream 0.1% for treatment of acne vulgaris.
Methods: Patients were randomized to receive combination therapy (dapsone gel 5% twice-daily plus tazarotene cream 0.1% daily) or monotherapy (tazarotene cream 0.1% daily). Efficacy and safety data were collected after 1, 2, 4, 8, and 12 weeks of treatment.
Results: Patients in both arms (n=86, dapsone + tazarotene; n=85, tazarotene) showed significant reductions from baseline in inflammatory, noninflammatory and total lesion counts (P<.001 for all). At 12 weeks, patients treated with dapsone plus tazarotene showed a greater reduction from baseline in noninflammatory (comedonal) and total lesion counts than tazarotene-treated patients (noninflammatory, 59.7 percent vs. 46.5 percent, P=.01; total, 63.3% vs. 53.6%, P=.02). The percentage of patients achieving treatment success (an investigator subjective score of 0 [none] or 1 [minimal]) was greater in dapsone plus tazarotene-treated patients (42.2%) than in tazarotene-treated patients (21.8%;P=.01). Both treatments were well tolerated.
Conclusion: Combination therapy with dapsone gel 5% plus tazarotene cream 0.1% was more effective than tazarotene monotherapy for treatment of comedonal acne. The results suggest that anti-inflammatory agents such as dapsone can effectively treat early stages of acne (both comedonal and noncomedonal) when used in combination with a retinoid.
J Drugs Dermatol. 2011;10(7):783-792.
Preadolescent Moderate Acne Vulgaris: A Randomized Trial of the Efficacy and Safety of Topical Adapalene-Benzoyl Peroxides
Lawrence F. Eichenfield MD,a Zoe Draelos MD,b Anne W. Lucky MD,c Adelaide A. Hebert MD,d Jeffrey Sugarman MD,e Linda Stein Gold MD,f Diane Rudisill BS,g Hong Liu MS,g and Vasant Manna MDg| |
METHODS: Enrolled subjects were male or female, with a score of 3 (moderate) on the Investigator’s Global Assessment (IGA) scale. Subjects were randomized to receive adapalene-BPO or vehicle once daily for up to 12 weeks. Efficacy was evaluated by success rate (percentage of subjects rated "clear" or "almost clear") at each visit, median percentage changes from baseline in total, inflammatory and non-inflammatory lesion counts at each visit, the Children’s Dermatology Life Quality Index (C DLQI) at baseline and week 12, and the Parent Assessment of Acne at week 12. Safety was assessed through evaluations of adverse events (AEs) and local tolerability [erythema, scaling, dryness, and stinging/burning on scales ranging from 0 (none) to 3 (severe)].
RESULTS: A total of 142 subjects were randomized to adapalene-BPO and 143 to vehicle. At study endpoint (week 12), adapalene-BPO was significantly superior to vehicle regarding treatment success (49.3% vs 15.9%, respectively), and regarding percentage reduction in total lesion counts (68.6% vs 19.3%), inflammatory (63.2% vs 14.3%), and non-inflammatory lesion counts (70.7% vs 14.6%) (all P<.001). More subjects using adapalene-BPO reported that their acne had no effect on their quality of life, and parents noted that their child’s acne significantly improved. Adapalene-BPO was well tolerated, with mean tolerability scores less than 1 (mild).
CONCLUSIONS: In preadolescents with acne, adapalene-BPO leads to significantly superior treatment success and lesion count reduction compared to vehicle.
J Drugs Dermatol. 2013;12(6):611-618.
Dapsone Gel 5% for the Treatment of Acne Vulgaris: Safety and Efficacy of Long-Term (1 Year) Treatment
Anne W. Lucky MD, J. Michael Maloney MD, Janet Roberts MD, Susan Taylor MD, Terry Jones MD, Mark Ling MD PhD, Steven Garrett DDS, for the Dapsone Gel Long-Term Safety Study Group| |
Fixed Combination of Clindamycin Phosphate 1.2% and Benzoyl Peroxide 3.75% Aqueous Gel: Long-Term Use in Adult Females With Moderate Acne Vulgaris
Leon H. Kircik MD| |
OBJECTIVE: To evaluate long-term efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (Clindamycin-BP 3.75%) aqueous gel in adult female patients with moderate acne vulgaris.
METHODS: Total of 20 patients, 25-63 years of age (mean [SD], 38 ± 10) with moderate acne (IGA=3) were treated with Clindamycin-BP 3.75% once-daily for 12 weeks. Patients who experienced ≥50% reduction in total lesion count continued treatment for a further 12 weeks. Mean (SD) percent reduction in lesion counts from baseline were assessed at week 4, 8, 12, 18, and 24. In addition, patients who were ‘clear’ or ‘almost clear’ were reported at week 12 and 24. Cutaneous tolerability (erythema, dryness, peeling, pruritus, and burning) and oiliness was assessed at baseline and each study visit. Adverse events were assessed throughout the study.
RESULTS: Clindamycin-BP 3.75% demonstrated statistical significant improvement from baseline and between each visit. At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts was 70.6% and 58.6%, respectively. Two patients failed to experience ≥50% lesion reduction by week 12. At week 24, mean percent reductions in inflammatory and noninflammatory lesion counts were 93.8% and 90; 72% of patients were ‘clear’ or ‘almost clear’. Overall the treatment was tolerable. There was one adverse event (sinus infection) that was not treatment-related.
CONCLUSIONS: Clindamycin-BP 3.75% gel demonstrates continued improvement in symptoms of moderate acne over 24 weeks, with good tolerability, demonstrating a clinical benefit of continued clindamycin-BP 3.75% gel as a maintenance therapy for acne in adult female patients.
J Drugs Dermatol. 2017;16(6):543-546.
The Clinical Effects of Zinc as a Topical or Oral Agent on the Clinical Response and Pathophysiologic Mechanisms of Acne: A Systematic Review of the Literature
Staci Brandt PA-C MSMR MBA| |
J Drugs Dermatol. 2013;12(5):542-545.
Photodynamic Therapy With Low-Strength ALA,Repeated Applications and Short Contact Periods(40-60 Minutes) in Acne, Photoaging and Vitiligo
Gabriel Serrano MD, Matilde Lorente MD, Madga Reyes MD, Fernando Millan MD, Adrian Lloret MD, Joaquin Melendez, Maria Navarro, Miguel Navarro MD| |
Comparison of Clindamycin 1% and Benzoyl Peroxide 5% Gel to a Novel Composition Containing Salicylic Acid, Capryloyl Salicylic Acid, HEPES, Glycolic Acid, Citric Acid, and Dioic Acid in the Treatment of Acne Vulgaris
Leslie S. Baumann MD, CPI,a Kristian Figueras MS,a Amanda Dahl BS CCRA,b Margarita Yatskayer MS,b and Christian Oresajo PhDb| |
J Drugs Dermatol. 2013;12(3):266-269.
Two Randomized, Double-Blind, Split-Face Studies to Compare the Irritation Potential of Two Topical Acne Fixed Combinations Over a 21-Day Treatment Period
Neal Bhatia MD,a Varsha Bhatt PhD,b Gina Martin MOT,b Radhakrishnan Pillai PhDb| |
Here, we compare the tolerability of two such developments, clindamycin-BP 3.75% gel and adapalene 0.3%-BP 2.5% gel, in healthy volunteers with no apparent facial redness or dryness over 21-days, using a split-face methodology.
Clindamycin-BP 3.75% gel was more tolerable than adapalene 0.3%-BP 2.5% gel over the duration of the two studies, with statistically significant differences in cumulative change from baseline starting as early as day 4 (stinging), day 5 (erythema, dryness, and scaling), day 6 (burning), and day 8 (itching); and in composite irritation index (stinging, erythema, dryness, scaling, burning, and itching) from day 4. Transepidermal water loss was less with clindamycin-BP 3.75% gel (statistically significant from day 8). Adverse events were twice as common with adapalene 0.3%-BP 2.5% gel.
These data suggest that clindamycin-BP 3.75% gel is likely to be better tolerated than adapalene 0.3%-BP 2.5% gel in moderate-to-severe acne.
J Drugs Dermatol. 2016;15(6):721-726.
Grace K. Kim DO and James Q. Del Rosso DO FAOCD| |
Mohamed L. Elsaie MD MBA,a,b Mahmoud F. Abdelhamid MD PhD,b
Lotfy T. Elsaaiee MD PhD FACTM,c and Hanaa M. Emam MD PhD b
Background: Botanical extracts and preparations have been used in different pathological conditions with success. An important group of phytochemical phenolic compounds are the catechins found in green tea. Acne is a widely occurring inflammatory condition that is estimated to affect 40 to 50 million Americans. Finding an effective, safe, cost-effective and well-tolerated treatment is the challenge.
Objective: To determine the efficacy of 2% green tea lotion in mild-to-moderate acne vulgaris.
Methods: Twenty patients fulfilling enrolment criteria were included. Green tea was given and applied twice daily for a period of 6 weeks. The patients were seen every 2 weeks to evaluate the lesions and any side effects. To determine efficacy on acne severity, the authors used both total lesion count (TLC) and their devised severity index (SI). Total lesions count (TLC) was calculated as papules + pustules while SI was scaled with numbers (1, 2 or 3) correlating to TLC in order of increasing intensity. TLC < 10 was given an SI of 1, TLC 10-20 was given an SI of 2 and TLC > 20 was given an SI of 3.
Results: The mean total lesion count (TLC) decreased from 24 before the treatment to 10 after 6 weeks after treatment, a reduction of 58.33%. The difference was statistically significant (P < 0.0001, 95% confidence interval [CI] of the difference = 8.58 – 19.42). The mean severity index (SI) decreased from 2.05 before treatment to 1.25 after 6 weeks treatment, a decrease of 39.02%. The difference was statistically significant (P < 0.0001, confidence interval [CI] of the difference = 0.54-1.26).
Conclusion: Topical 2% green tea lotion is an effective, cost-effective treatment for mild-to-moderate acne vulgaris.
Fractional CO2 Laser Treatment vs Autologous Fat Transfer in the Treatment of Acne Scars: A Comparative Study
Omar A. Azzam MD a, Ahmed T. Atta MDb, Rehab M. Sobhi MD, and Pakinam I.N. Mostafa MSca| |
Objective: To compare fractional CO2 laser treatment and fat grafting in the treatment of acne scars.
Materials and methods: Twenty patients were included in this study, 10 received 3 sessions of fractional CO2 laser therapy, and 10 received fat grafting. All patients were then followed up for 3 months, and results were assessed with digital photographs taken by a committee of 3 physicians, by a single-blinded physician, and by reports of patient satisfaction.
Results: In the fractional CO2 laser treatment group, under 20% of patients were graded as having excellent scar improvement, 0 as having marked scar improvement, under 10% as having mild scar improvement, and almost 70% as having moderate scar improvement. In the fat-grafting group, the scar and overall improvement were graded as 30% excellent, 30% marked, 20% moderate, and 20% mild.
Conclusion: Fat grafting proved to be more effective in the treatment of acne scars than ablative fractional CO2 laser treatment. There were many points in its favor, the most significant being the clinical improvement in scars and texture. This supports the stem cell theory of adipose tissue in regenerative medicine.
J Drugs Dermatol. 2013;12(1):e7-e13.
Treatment of Moderate to Severe Acne Vulgaris in a Hispanic Population: A Post-Hoc Analysis of Efficacy and Tolerability of Clindamycin Phosphate 1.2%/Benzoyl Peroxide 2.5% Gel
Background: Acne in Hispanics is an increasing problem, presenting unique challenges. Although combination therapy is now a standard of care in acne, concerns exist with the increased potential irritation and dryness in this population and the potential for hyperpigmentation. There is a paucity of clinical studies that evaluate the efficacy and tolerability of acne medications in Hispanics.
Methods: A post-hoc analysis of efficacy and cutaneous tolerability in 458 Hispanic subjects receiving clindamycin phosphate 1.2%/BPO 2.5% gel, individual active ingredients and vehicle from two 12-week multicenter double-blind studies that enrolled 2813 subjects with moderate to severe acne.
Results: Median reductions in inflammatory lesions, noninflammatory, and total lesions (71.6%, 50.9% and 55.1%, respectively) were significantly greater with clindamycin phosphate 1.2%/BPO 2.5% gel versus the individual active ingredients and vehicle. Treatment success (35.6% "clear/almost clear") and patient satisfaction (83.2%) were also significantly greater than vehicle at week 12. Cutaneous tolerability was excellent with all mean scores less than or equal to 0.2 at week 12 (where 1=mild).
Conclusions: Overall efficacy and tolerability with clindamycin phosphate 1.2%/BPO 2.5% gel were better in the Hispanic population compared to the total study population. Hispanic acne subjects were not found to be more susceptible to cutaneous irritation from treatment with clindamycin phosphate 1.2%/BPO 2.5% gel and both efficacy and tolerability was excellent. J Drugs Dermatol.
J Drugs Dermatol. 2012;11(4):455-459.
Clinical Safety and Efficacy Studies of a Novel Formulation Combining 1.2% Clindamycin Phosphate and 0.025% Tretinoin and for the Treatment of Acne Vulgaris
Joel Schlessinger MD, Alan Menter MD, Michael Gold MD, Craig Leonardi MD, Lawrence F. Eichenfield MD, R. Todd Plott PhD, James J. Leyden MD (ZIANA™ Study Group)| |
Candace Thornton Spann MD| |
J Drugs Dermatol. 2011;10(6):654-657.
Neal D. Bhatia MDa and James Q. Del Rosso DO FAOCDb| |
The pathophysiology of papulopustular rosacea (PPR) is primarily characterized by inflammation associated with several factors such as abnormal innate immune response, neurovascular dysregulation, stratum corneum barrier dysfunction, and depletion of antioxidant reserve, with no definitive evidence supporting an underlying microbial etiology. Several molecular inflammatory pathways have now been identified that enable the development of therapeutic agents that target the signs and symptoms of disease by modifying specific pathophysiological mechanisms. Available evidence demonstrates that topical and oral agents commonly used to treat PPR appear to modify some of these pathophysiological mechanisms and may prove to be complimentary when used in combination potentially leading to better therapeutic outcomes.
During the past two decades, six clinical studies have been published on the benefits of combining oral and topical therapies for PPR. Four studies suggest that doxycycline, including anti-inflammatory dose doxycycline (doxycycline 40 mg modified-release capsule once daily) can be combined with topical metronidazole or azelaic acid in patients with PPR to achieve more rapid control of a flare. At present, subantimicrobial dosing of a tetracycline agent that also maintains anti-inflammatory activity has only been established with doxycycline. Although antibiotic doses of tetracycline agents (such as doxycycline, minocycline, and tetracycline) are known to be effective for PPR, the use of subantimicrobial dosing of doxycycline avoids the risk of antibiotic resistance.
J Drugs Dermatol. 2012;11(7):838-844.
Introduction: This study evaluated the efficacy and tolerability of treating mild-to-moderate facial acne using a new, hand-held,
light-emitting diode blue light device in conjunction with a foam cleanser containing 5% glycolic acid and 2% salicylic acid plus a skin
rebuilding serum containing 1.25% salicylic acid, 0.5% niacinamide, 0.08% liposomal-based azelaic acid and superoxide dismutase.
Methods: Volunteers with mild-to-moderate facial inflammatory acne used the blue light device twice daily for eight weeks, plus the cleanser before treatments and the serum after each evening treatment.
Results: Among 33 subjects aged 25–45 years old, 28 completed. In a 3 cm x 5 cm target area receiving a daily dose of ~29 J/cm2, treatment was associated with significant reductions from baseline in the inflammatory lesion count from week 1 onward (P≤.01) and in the non-inflammatory lesion count from week 4 onward (P≤.05). The number of flares was significantly reduced from baseline from week 2 onward (P≤.05), and flare severity and flare redness were significantly reduced from baseline from week 4 onward (P≤.01 and P≤.05, respectively). At week 8, more than 90 percent of subjects reported improvements in their skin’s overall appearance, clarity, radiance, tone, texture and smoothness. In addition, 82 percent were satisfied, very satisfied, or extremely satisfied with the blue light treatment system and 86 percent agreed the treatment system was much gentler than traditional acne treatments.
Conclusion: The blue light treatment system offers effective, rapid, convenient and well tolerated treatment of inflammatory and non-inflammatory acne lesions. The majority of subjects consider it much gentler than traditional acne treatments and it facilitates effective treatment without the need for antibiotic exposure. The blue light treatment system and blue light therapy alone are attractive treatment options for acne vulgaris, both as alternatives to traditional acne treatments and as adjunctive treatments to complement existing therapies.
J Drugs Dermatol. 2011;10(6):596-602.
Treatment of 2,453 Acne Vulgaris Patients Aged 12–17 Years With the Fixed-dose Adapalene-benzoyl Peroxide Combination Topical Gel: Efficacy and Safety
Lawrence F. Eichenfield MD, Joseph L. Jorizzo MD, Thomas Dirschka MD, Amy Forman Taub MD, Charles Lynde MD,e Michael Graeber MD, Nabil Kerrouche MS| |
A Subgroup Analysis to Evaluate the Efficacy and Safety of Adapalene-Benzoyl Peroxide Topical Gel in Black Subjects With Moderate Acne
Andrew F. Alexis MD MPH,a Lori A. Johnson PhD,b Nabil Kerrouche MSc,c and Valerie D. Callender MDd| |
J Drugs Dermatol. 2014;13(2):170-174.
Digital Videography Assessment of Patients' Experiences Using Adapalene-Benzoyl Peroxide Gel in the Treatment of Acne Vulgaris
Background: Acne profoundly affects patients' lives, but the effect of treatment is not fully characterized.
Objective: The purpose of this study was to explore patients' experiences and viewpoints regarding treatment for mild to moderate acne vulgaris.
Methods: This was an open-label, single-center study of 30 patients with mild to moderate acne vulgaris, treated with adapalene 0.1%/benzoyl peroxide 2.5% (adapalene-BPO gel) once daily for 12 weeks. An acne-specific quality of life questionnaire (Acne-QoL©) was conducted. Each subject's global assessment (SGA) was recorded at baseline and weeks 4, 8, and 12. Photographs were taken and video interviews were recorded. Local tolerability assessments and incidence of adverse events were documented.
Results: A statistically significant number of patients were clear/almost clear (treatment success) at week 12 (P<.001). At week 12, patients experienced a 44.1% and 57.1% mean reduction in inflammatory and noninflammatory lesions, respectively. By week 12, 67% of the patients in the video population (n=27) believed they had achieved treatment success (P<.001). Patients reported higher Acne-QoL© scores at week 12 compared to baseline, indicating better quality of life after treatment with adapalene-BPO gel (P<.001 for all domains). No unexpected adverse or serious adverse events were reported.
Limitations: This was an open-label study of 12 weeks duration.
Conclusion: Overall, patients with mild to moderate acne treated with adapalene-BPO gel showed significant improvement in disease severity and quality of life. The video recordings chronicled the patients' experiences throughout the treatment process.
J Drugs Dermatol. 2012;11(8):919-925.
Topical Treatment With an Agent Disruptive to P. acnes Biofilm Provides Positive Therapeutic Response: Results of a Randomized Clinical Trial
Michael J. Bernhardt MDa and Matthew F. Myntti PhDb| |
J Drugs Dermatol. 2016;15(6):677-683.
Christy C. Riddle MD, Shaundre N. Terrell BS, Molly B. Menser DO, Daniel J. Aires MD,Eric S. Schweiger MD| |
Objective: To review the results of clinical trials and case series with respect to light source, topical photosensitizing agent, adverse events, efficacy and skin type.
Methods: A non-critical review is presented of a PubMed search for studies examining PDT in the treatment of acne vulgaris.
Results: The authors found 21 clinical trials and case series of various designs. Eight studies employed a split-face design comparing photosensitizer to placebo, no treatment or another photosensitizer. Two trials used three test spots and one control spot per patient. Three studies utilized control subjects receiving no photosensitizer with or without light therapy. All 21 studies reported a reduction in inflammatory lesions and/or a significant improvement in acne. The light sources utilized included blue light, pulsed-dye laser (PDL), intense pulsed light (IPL) and red light. Studies comparing the use of PDT to light therapy alone demonstrated greater improvement in treatment groups pretreated with a photosensitizer.
Conclusion: All studies reported reduction in inflammatory lesions or significant improvement in acne. Several studies confirm a light source combined with photosensitizer is superior to light alone. Adverse reactions including photosensitivity, pustular eruptions, and crusting varied among photosensitizers and light sources. PDT appears to be a useful therapeutic option for acne patients who are recalcitrant to standard treatments and poor candidates for systemic retinoids. Further studies are still needed before a consensus protocol can be established. Additional investigations are needed to establish optimal incubation time, activating light source and frequency of treatment.
Thomas J. Stephens PhD,a John P. McCook BS,b and James H. Herndon Jr. MDc| |
OBJECTIVES: This single-center pilot study was conducted to assess the efficacy and safety of a liposomal dispersion of topically applied sodium copper chlorophyllin complex in subjects with mild-moderate acne and large, visible pores over a course of 3 weeks.
METHODS: Subjects were supplied with the test product, a topical gel containing a liposomal dispersion of sodium copper chlorophyllin complex (0.1%) with directions to apply a small amount to the facial area twice daily. Clinical assessments were performed at screening/baseline and at week 3. VISIA readings were taken and self-assessment questionnaires were conducted.
RESULTS: 10 subjects were enrolled and completed the 3-week study. All clinical efficacy parameters showed statistically significant improvements over baseline at week 3. The study product was well tolerated. Subject questionnaires showed the test product was highly rated.
CONCLUSIONS: In this pilot study, a topical formulation containing a liposomal dispersion of sodium copper chlorophyllin complex was shown to be clinically effective and well tolerated for the treatment of mild-moderate acne and large, visible pores when used for 3 weeks.
J Drugs Dermatol. 2015;14(6):589-592.
The Efficacy and Tolerability of Dapsone 5% Gel in Female vs Male PatientsWith Facial Acne Vulgaris: Gender as a Clinically Relevant Outcome Variable
Objective: To evaluate the effect of gender on the efficacy and tolerability of dapsone 5% gel.
Methods: This was a pooled analysis of data from 2 identical phase 3 randomized, double-blind, and vehicle-controlled trials (DAP0203 and DAP0204) of dapsone 5% gel conducted in the United States and Canada between November 2002 and September 2003. A total of 2,898 patients with acne vulgaris were included in the pooled analysis. Of these, 1,453 patients (753 female, 700 male) received dapsone 5% gel twice daily, and 1,445 patients (767 female, 678 male) received vehicle twice daily. End points included the mean percentage reduction from baseline in acne lesion counts and the proportion of patients achieving clinical success (Global Acne Assessment Scale score of 0, clear skin, or 1, almost clear skin). Assessments were performed at baseline and at weeks 2, 4, 6, 8, and 12.
Results: The mean percentage reduction in acne lesion counts at 12 weeks was significantly greater in females than males in both treatment groups. The mean reduction in total lesion counts in dapsone-treated females and males was, respectively, 46.6% vs 35.8% (P<.0001). Reductions in papulopustular and comedonal lesion counts were likewise significantly higher in female than male patients (each P<.0001). Significantly more dapsone-treated females than males achieved clinical success (48.6% vs 34.4%; P=.0003).
Conclusion: The response to dapsone 5% gel appears to be influenced by gender, with female patients experiencing a significantly greater reduction in acne lesion counts and a significantly higher clinical success rate following 12 weeks of treatment. These data suggest that gender is a novel predictor of outcome that should be considered in acne clinical trial design and analysis.
J Drugs Dermatol. 2012;11(12):1417-1421.
Improvement of Atrophic Acne Scars in Skin of Color Using Topical Synthetic Epidermal Growth Factor (EGF) Serum: A Pilot Study
Marie Alexia Stoddard BS,a Jennifer Herrmann MD,b,c,d Lauren Moy MD,e and Ronald Moy MDb,f| |
BACKGROUND: Atrophic scarring in skin of color is a common, permanent, and distressing result of uncontrolled acne vulgaris. Ablative lasers and chemical peels are frequently used to improve the appearance of atrophic scars, primarily through the stimulation of collagen and elastin; however, these treatment modalities are associated with risks, such as dyspigmentation and hypertrophic scarring, especially in patients with darker skin.
OBJECTIVE: We evaluated the efficacy of topically applied synthetic epidermal growth factor (EGF) serum in reducing the appearance of atrophic acne scars in skin of color.
METHODS: A single-center clinical trial was performed on twelve healthy men and women (average age 32.5) with Fitzpatrick Type IV-V skin and evidence of facial grade II-IV atrophic acne scars. Subjects applied topical EGF serum to the full-face twice daily for 12 weeks. Scar improvement was investigated at each visit using an Investigator Global Assessment (IGA), a Goodman grade, clinical photography, and patient self-assessment.
RESULTS: Eleven subjects completed the trial. Compared to baseline, there was an improvement in mean IGA score from 3.36 (SEM = 0.15) to 2.18 (SEM = 0.33). Mean Goodman grade was reduced from 2.73 (SEM = 0.19) to 2.55 (SEM = 0.21). Of the eleven pairs of before and after photographs, nine were correctly chosen as the post-treatment image by a blind investigator. On self-assessment, 81% reported a “good” to “excellent” improvement in their scars compared to baseline (P = 0.004).
CONCLUSION: Topical EGF may improve the appearance of atrophic acne scars in skin of color. Additional, larger studies should be conducted to better characterize improvement.
J Drugs Dermatol. 2017;16(4):322-326.
Nawaf Al-Mutairi MD FRCPC, Y. Manchanda MD DNB, Osama Nour-Eldin MSc, Amani Sultan MB BCH| |
Dapsone Gel 5% in Combination With Adapalene Gel 0.1%, Benzoyl Peroxide Gel4% or Moisturizer for the Treatment of Acne Vulgaris: A 12-Week, Randomized,Double-Blind Study
Alan B. Fleischer Jr. MD, Alan Shalita MD, Lawrence F. Eichenfield MD, William Abramovits MD,Anne Lucky MD, Steven Garrett DDS, for the Dapsone Gel in Combination Treatment Study Group| |
Methods: This was a twelve-week, randomized, double-blind study. Patients aged 12 years and older (n=301) applied dapsone gel twice daily and were randomly assigned (1:1:1) to one of three additional treatments, applied once daily.
Results: By week 12, dapsone gel combined with any of the three additional treatments reduced the mean number of inflammatory lesions. However, the authors did not detect a significant difference in the reduction of inflammatory lesions when dapsone was used in combination with adapalene gel or with benzoyl peroxide gel compared to the dapsone plus moisturizer combination group (P=0.052 for both versus moisturizer combination). Patients treated with dapsone gel combined with adapalene showed a significantly better response in reduction in non-inflammatory and total acne lesion count than those who received the moisturizer combination. Local adverse reactions in all three treatment groups were minimal and generally mild in severity.
Conclusion: Dapsone gel in combination with adapalene gel or benzoyl peroxide gel is safe and well tolerated for the treatment of acne vulgaris.
Use of Dapsone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Dapsone 5% Gel Combination Treatment
Leon H. Kircik MD| |
OBJECTIVE: To assess the safety and efficacy of combination therapy with dapsone 5% gel with oral doxycycline hyclate 100mg, followed by monotherapy with dapsone 5% gel in improving and maintaining response in patients with moderate to severe acne.
METHODS: In this open-label study, all patients applied dapsone 5% gel twice daily along with doxycycline hyclate 100mg once daily for 12 weeks. Subjects who achieved a qualifying improvement at week 12 continued to the second phase of the study in which they applied only dapsone 5% gel twice daily for maintenance therapy of 12 more weeks. Subjects were evaluated for safety and efficacy at weeks 4, 8, 12, 16, 20, and 24.
RESULTS: All subjects (n=30) in the initial phase qualified to enter the maintenance phase. 82% of participants maintained their treatment response (Investigator’s Global Assessment score) at week 24. The regimen was safe and well tolerated.
CONCLUSIONS: The combination oral doxycycline hyclate 100 mg with topical dapsone 5% gel twice daily is an effective and well-tolerated regimen to treat moderate to severe acne vulgaris. After discontinuation of doxycycline, topical dapsone 5% gel is effective at maintaining a therapeutic response. These data suggest that topical dapsone 5% gel can be used effectively for long-term acne maintenance treatment without the risk of developing antibiotic resistance.
J Drugs Dermatol. 2016;15(2):191-195.
Improvement in Atrophic Acne Scars Using Topical Synthetic Epidermal Growth Factor (EGF) Serum: A Pilot Study
Rachel Seidel BAa and Ronald L. Moy MD FAADb,c| |
OBJECTIVE: We evaluated the efficacy of a topically applied synthetic epidermal growth factor (EGF) serum in reducing the appearance of atrophic acne scars.
METHODS: A single-center clinical trial was performed on nine self-selected male and female patients with Goodman & Baron grade II-IV atrophic acne scars. Subjects followed a standardized treatment regimen, including twice-daily application of EGF serum to scarred areas over 12 weeks. Subject progress was evaluated at baseline and 4-week intervals by clinical photography, Investigator Global Assessment (IGA), Goodman grade and patient self-assessment. Final patient perceptions were shared by written self-assessment at the end of the study. Before and after photographs were also evaluated by a blind investigator.
RESULTS: Eight subjects completed the trial. Compared to baseline, there was an improvement in mean IGA score from 2.875 (SEM= .327) to 2.38 (SEM = .375). Mean Goodman grade was reduced from 3.00 (SEM = .309) to 2.75 (SEM = .25). Of the eight pairs of before and after photographs given to a blind investigator, five were correctly chosen as the post-treatment image. Two were assessed as “excellent” (76-100%) improvement and three were assessed as "good" (50-75%) improvement. A one-tailed paired student t-test (α = .05) using blind investigator ratings of scar severity for each before and after photograph yielded a P-value of .0019, confirming the difference as statistically significant. On final self-assessment, all but one patient reported “good” to “excellent” improvement in their scars compared to baseline. 75% of patients who received alternative treatments in prior years reported EGF serum to be more efficacious.
CONCLUSION: These results suggest that topical EGF may improve the appearance of atrophic acne scars, though further study and more objective evaluation measures are required for definitive conclusions to be drawn.
J Drugs Dermatol. 2015;14(9):1005-1010.
Customized Single-agent Therapy Management of Severe Inflammatory Acne: A Randomized, Double-blind, Parallel-group, Controlled Study of a New Treatment - Adapalene 0.3%-Benzoyl Peroxide 2.5% Gel
Jonathan Weiss MD,a Linda Stein Gold MD,b Matthew Leoni MD,c Maria Jose Rueda MD,d Hong Liu Msc,c and Emil Tanghetti MDe| |
OBJECTIVES: To demonstrate superior efficacy of adapalene 0.3%-benzoyl peroxide 2.5% gel (0.3% A/BPO) vs. vehicle, and to assess efficacy of 0.3% A/BPO vs. 0.1% A/BPO in subjects with severe inflammatory acne (Investigator’s Global Assessment [IGA] of 4) in the context of a larger trial in a moderate and severe population.
METHODS: This was a multicenter, randomized, double-blind, parallel-group, 12-week study. Subjects were randomized to receive 0.3% A/BPO, 0.1% A/BPO (benchmark) or vehicle (comparator) once daily for 12 weeks. Co-primary efficacy endpoints were success rate at week 12 (percentage of subjects rated “clear” or “almost clear,” ≥3-grade IGA improvement), and change in inflammatory (IN) and noninflammatory (NIN) lesion counts from baseline to week 12. Secondary efficacy endpoints were percent changes in IN and NIN lesion counts. Safety endpoints were incidence of adverse events (AEs) and local tolerability signs/symptoms.
RESULTS: In the severe inflammatory acne population, a total of 252 subjects were randomized with 106, 112 and 34 subjects in the 0.3% A/BPO, 0.1% A/BPO and vehicle groups, respectively, reaching a high rate of study completion (88.5%). At week 12, both 0.3% A/BPO and 0.1% A/BPO were superior to vehicle in terms of lesion count reduction. However for success rate, only 0.3% A/BPO achieved significantly greater efficacy over vehicle with a treatment difference of 20.1% (31.9% vs. 11.8%; 95% Confidence Interval (CI): [6.0%, 34.2%], P=.029), whereas 0.1% A/BPO did not (treatment difference vs. vehicle of 8.8%; P=.443). This translates to an 11% difference between active treatments in favor of 0.3% A/BPO. Also, 0.3% A/BPO was safe and well tolerated.
CONCLUSIONS: Availability of this new treatment option should allow clinicians to better customize severe inflammatory acne management, and the high-strength product provides a step-up treatment when needed.
J Drugs Dermatol. 2015;14(12):1427-1435.
The Clinical Impact of Vehicle Technology Using a Patented Formulation of Benzoyl Peroxide 5%/Clindamycin 1% Gel Containing Dimethicone and Glycerin in Combination with Topical Retinoids and Sunscreens
James Q. Del Rosso DO FAOCD, Emil Tanghetti MD| |
Leon H. Kircik MD| |
Amy E. Rose MD| |
Evaluation of the Performance of a Nature-Based Sensitive Skin Regimen in Subjects With Clinically Diagnosed Sensitive Skin
Zoe Diana Draelos MD,a Stanley B. Levy MD,b Celeste Lutrario,c Hemali Gunt PhDc| |
Comparison of Clindamycin/Benzoyl Peroxide, Tretinoin Plus Clindamycin, and the Combination of Clindamycin/Benzoyl Peroxide and Tretinoin Plus Clindamycin in the Treatment of Acne Vulgaris: A Randomized, Blinded Study
Steven Bowman MD, Michael Gold MD, Adnan Nasir MD PhD, George Vamvakias| |
Rajesh Balkrishnan PhD, Julia C. Sansbury MD, Rahul A. Shenolikar MS, Alan B. Fleischer Jr. MD, Steven R. Feldman MD PhD| |
Noah Scheinfeld JD MD, Sripal Bangalore MD| |
Isotretinoins most significnt side effect is the induction of birth defects if a fetus is exposed to isotretinoin, which is pregnancy category X. Isotretinoin should be used with 2 forms of birth control by fecund women. It can rarely increase serum levels of triglycerides, which can, if very elevated, be related to the development of pancratitis and xanthomas. Isotretinoins well-documented but rarer side effects include intracranial hypertnesion. It can induce bony changes. A review of the literature demonsteates that isotrtinoin is not linked to depression ans suicide.
Facial swelling has been linked to isotretinoin use in 3 previous case reports. We note herein the first case of facial swelling that occurred in an acne patient being treated with isotretinoin who at the time the selling developed has no cysts, comedones, pustules, or evidence of bacterial infection. Possible reasons for the patients facial swelling include some type of retinoid induced angioedema, exacerbation of inflammation by isotretinoin, and istretinoin induced capillary leak syndrome.
An Aqueous Gel Fixed Combination of Clindamycin Phosphate 1.2% and Benzoyl Peroxide 3.75% for the Once-Daily Treatment of Moderate to Severe Acne Vulgaris
David M. Pariser MD,a Phoebe Rich MD,b Fran E. Cook-Bolden MD,c and Andrew Korotzer PhDd| |
METHODS: A total of 498 patients, 12-40 years of age, were randomized to receive clindamycin-BP 3.75% or vehicle in a double-blind, controlled 12-week, 2-arm study evaluating safety and efficacy using inflammatory and noninflammatory lesion counts, Evaluator Global Severity Scores (EGSS) and subject self-assessment (SSA). In addition, patients completed a patient satisfaction survey (PSS), acne-specific QoL questionnaire, and assessed their facial skin for shininess/oiliness.
RESULTS: Clindamycin-BP 3.75% demonstrated statistical superiority to vehicle in reducing both inflammatory and noninflammatory lesions and acne severity. Clindamycin-BP 3.75% showed greater efficacy relative to vehicle in assessments of skin oiliness, SSA and PSS. No substantive differences were seen in cutaneous tolerability among treatment groups and no patients discontinued treatment with Clindamycin-BP 3.75% because of adverse events.
LIMITATIONS: Data from controlled studies may differ from clinical practice. It is not possible to determine the contributions from the individual active ingredients.
CONCLUSIONS: Clindamycin-BP 3.75% provides statistically significant greater efficacy than vehicle with a favorable safety and tolerability profile.
J Drugs Dermatol. 2014;13(9):1083-1089.
A Multicenter Efficacy and Tolerability Evaluation of Benzoyl Peroxide in a 10% Urea Vehicle for the Treatment of Acne Vulgaris
Michael H. Gold MD| |
Objective: To assess the efficacy and tolerability of the treatment of acne vulgaris with multiple strengths of benzoyl peroxide in a 10% urea vehicle gel or cream and cleanser.
Methods: A multicenter, non-randomized, open-label study in which 1,089 patients with acne vulgaris were enrolled at 133 participating physician office sites. Qualifying and consenting patients were prescribed either 4.5% or 8.5% benzoyl peroxide in a 10% urea vehicle cream or gel and cleanser. Additional medications were permitted during the study with the exception of those containing benzoyl peroxide. The physician assessed lesion counts, both inflammatory and non-inflammatory, at baseline and Week 4. Dryness and erythema were rated by the physician on a scale from 0 (none) to 8 (severe or deep) at baseline and Week 4.
Results: Nine hundred sixty-three patients completed the study. The following significant treatment arms were analyzed: patients treated with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle product only, patients treated with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle products along with oral doxycycline, and patients treated with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle products along with oral minocycline. A 44% (n=567) mean reduction in total lesion count was observed after 4 weeks of treatment with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle products only. Dual therapy using oral doxycycline (n=17) proved to be even more effective with a significant mean reduction in lesion count of 52% after only 4 weeks of treatment. Dual therapy using oral minocycline (n=21) yielded a significant mean reduction in lesion count of 34% after 14 weeks of treatment. The overall tolerability of the treatment illustrated the utility of urea as a moisturizing agent.
Conclusion: Benzoyl peroxide in a 10% urea vehicle gel or cream and cleanser, used once daily for 4 weeks found to be both effective and well tolerated for the treatment of symptoms related to acne vulgaris.
Molly M Warthan BA, Cynthia A Jumper MD, Jennifer L Smith MD| |
Pharmacokinetic Comparison of Once-Daily Topical Minocycline Foam 4% vs Oral Minocycline for Moderate-to-Severe Acne
Terry M Jones MD,a Herman Ellman MD,b Tina deVries PhDb| |
J Drugs Dermatol. 2017;16(10):1022-1028.
Clinical Experience Results with Clindamycin 1% Benzoyl Peroxide 5% Gel (Duac®) as Monotherapy and in Combination
Joseph B. Bikowski MD| |
Christina Shwereb, Eve J Lowenstein MD PhD| |
Leon H. Kircik MD| |
Leon H. Kircik MD| |
Julie C. Harper MD| |
Efficacy and Safety of a Ceramide Containing Moisturizer Followed by Fixed-dose Clindamycin Phosphate 1.2%/Benzoyl Peroxide 2.5% Gel in the Morning in Combination With a Ceramide Containing Moisturizer Followed by Tretinoin 0.05% Gel in the Evening for the Treatment of Facial Acne Vulgaris
Joshua A. Zeichner MD, Rita V. Patel MD, Madelaine Haddican MD, and Vicky Wong BS| |
J Drugs Dermatol. 2012;11(6):748-752
Guy Webster MD PhD| |
A Phase IV, Open-Label Study Evaluating the Use of Triple-Combination Therapy With Minocycline HCl Extended-Release Tablets, a Topical Antibiotic/Retinoid Preparation and Benzoyl Peroxide in Patients With Moderate to Severe Acne Vulgaris
Andrea L. Zaenglein MD,a Ava Shamban MD,b Guy Webster MD PhD,c James Del Rosso DO FAOCD,d Jeffrey S. Dover MD FRCPC,e Leonard Swinyer MD,f Linda Stein MD,g Xiaoming Lin MS RN,h Zoe Draelos MD,i Michael Gold MD,j and Diane Thiboutot MDa| |
METHODS: Patients were required to be aged 12–30 years with moderate to severe acne (grades 3–4 acne on the Investigator's Global Assessment [IGA]) and deemed potential candidates for treatment with isotretinoin. Enrolled patients were given triple-combination therapy, defined in this study as oral minocycline HCl extended release 1 mg/kg QD, 6% BP foaming cloths used QD, and clindamycin phosphate 1.2%/tretinoin 0.025% gel applied QD, and were evaluated at baseline and weeks 2, 4, 8, and 12.
RESULTS: A total of 97 patients were enrolled in the study. At week 12, 89% of patients had at least a one-grade improvement from baseline IGA and 96% had at least a one-grade improvement from baseline Global Aesthetic Improvement Scale score. Mean±SD in- flammatory, non-inflammatory, and total lesion counts decreased from baseline by 61.8%±38.3%, 48.8%±34.5%, and 56.5%±29.9%, respectively. The percentage of patients evaluated as candidates for isotretinoin by independent photographic review was 77% (69/90) at baseline and only 16% (14/90) at week 12. Treatment-related adverse events (AEs) occurred in eight of 97 (8%) patients. Triplecombination therapy was not associated with any serious AEs or AEs leading to discontinuation.
CONCLUSION: Triple-combination therapy was well tolerated and substantially reduced facial acne lesion counts, with 84% of patients judged to no longer be candidates for isotretinoin therapy by study end. These data support the clinical observation that a triple-combination regimen incorporating oral minocycline (dosed by patient weight), BP foaming cloths 6% QD, and clindamycin phosphate 1.2%/ tretinoin 0.025% gel QD can substantially improve moderate to severe acne vulgaris.
J Drugs Dermatol. 2013;12(6):619-625.
Gender as a Clinically Relevant Outcome Variable in Acne: Benefits of a FixedCombination Clindamycin Phosphate (1.2%) and Benzoyl Peroxide (2.5%)Aqueous Gel
Julie C. Harper MD
The Dermatology and Skin Care Center of Birmingham, Birmingham, AL
Methods: We performed a post hoc analysis of the efficacy and cutaneous tolerability in 797 subjects receiving clindamycin phosphate 1.2%/BPO 2.5% gel from two 12-week, multicenter studies that enrolled 2,813 subjects with moderate to severe acne. Efficacy and tolerability were compared with both male and female subjects, overall and stratified by age (12-18 years and ≥18 years).
Results: Absolute mean reductions in lesion counts with clindamycin phosphate 1.2%/BPO 2.5% gel were comparable and not significantly different across gender and age groups. Net reductions were greater in the adolescent groups. Treatment success in the older males was significantly greater (P=.046) compared with the adolescent males, and the difference between the male and female adolescent groups was significant in favor of the female subjects (P=.046). Cutaneous tolerability was comparable across all groups and between clindamycin phosphate 1.2%/BPO 2.5% gel and vehicle.
Conclusions: Clindamycin phosphate 1.2%/BPO 2.5% gel provided comparable reductions in lesion counts across all 4 groups; however, the impact was greater in those subjects with more severe acne (the older males and adolescent females), and net benefit was greater in the adolescent subjects.
J Drugs Dermatol. 2012;11(12):1440-1445.
Why Are Dermatologists Still Talking About Acne? Because So Many People Have It... and We Are Always Seeking Better Ways to Manage It
James Q. Del Rosso, DO| |
James Q. Del Rosso DO FAOCD| |
Jonathan S. Weiss MD| |
Hilary E. Baldwin MD,a Marge Nighland BS,b Clare Kendall MA,c David A. Mays PharmD MBA,c Rachel Grossman MD,b,c and Joan Newburger PhDc| |
J Drugs Dermatol. 2013;12(6):638-642, e94-e105.
Moderate to Severe Acne in Adolescents With Skin of Color: Benefits of a Fixed Combination Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5% Aqueous Gel
Objective: Acne is common in adolescents and especially difficult to manage in people with color. A fixed combination of clindamycin
phosphate and benzoyl peroxide (BPO) (clindamycin phosphate 1.2%/BPO 2.5% gel) was evaluated to determine its utility in treating
moderate to severe acne in adolescents with skin of color.
Methods: Three hundred thirty-seven adolescent acne subjects (aged 12 to <18 years) with skin of color were evaluated from 2 multicenter, double-blind studies. Subjects were randomized to receive clindamycin phosphate 1.2%/BPO 2.5% gel or vehicle, once daily for 12 weeks. Efficacy and tolerability were evaluated. Data were compared with an adolescent (A) and skin of color (B) cohort from the same pivotal study enrolling 2,813 subjects.
Results: Superior mean percent reductions in inflammatory, noninflammatory, and total lesion counts were observed in subjects receiving clindamycin phosphate 1.2%/BPO 2.5% gel compared to vehicle. At week 12, clindamycin phosphate 1.2%/BPO 2.5% gel showed similar lesion reduction compared to groups A and B (P<0.001). Treatment success with clindamycin phosphate 1.2%/BPO 2.5% gel, assessed by investigator and subject, was superior to vehicle and comparable to that seen in groups A and B (P<0.001). Clindamycin phosphate 1.2%/ BPO 2.5% gel was associated with a low incidence of treatment-related AEs and a favorable cutaneous tolerability profile.
Conclusions: Clindamycin phosphate 1.2%/BPO 2.5% gel has been shown to be effective, safe, and well tolerated in moderate to severe acne in adolescents with skin of color.
J Drugs Dermatol. 2012;11(7):818-824.
Isotretinoin Does Not Prolong QT Intervals and QT Dispersion in Patients With Severe Acne: A Surprising Finding for a Drug With Numerous Side Effects
Background: Isotretinoin is a widely prescribed drug for the treatment of severe acne. Several adverse cardiac effects due to isotretinoin
have been previously reported. However, no data exist on the effects of isotretinoin therapy on QT intervals.
Objective: To investigate the effects of isotretinoin therapy on QT intervals and QT dispersion, and also to see if it is related to serum lipids, homocysteine and lipoprotein (a) or not.
Methods: Forty-five patients with severe acne (mean age 21±6 years, range 14-38 years; 26 female) were included in the study. Twelve-lead surface electrocardiograms (ECGs) were acquired at three stages: before therapy and at the ends of the first and sixth months of 0.8 mg/kg/day of isotretinoin therapy. Serum levels of triglycerides, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, very low density lipoprotein cholesterol, homocysteine and lipoprotein (a) were also measured at the day of ECG recordings. Minimum and maximum QT intervals were measured and QT dispersion was calculated.
Results: Mean heart rates were similar throughout the isotretinoin therapy. Serum levels of lipids, homocysteine and lipoprotein (a) all increased significantly at the end of the first month and remained significantly elevated at the end of sixth month (P<0.05 for both stages). QT intervals and QT dispersion did not differ significantly throughout the six months of isotretinoin therapy (P>0.05).
Conclusions: In patients with severe acne, six months of 0.8 mg/kg/day of isotretinoin therapy neither prolongs QT interval, nor increases QT dispersion. This effect is not related to blood lipids, homocysteine or lipoprotein (a) levels. Our findings indicate that from the point of polymorphic ventricular tachycardia risk, 0.8 mg/kg/day of isotretinoin therapy is a safe choice in acne treatment.
J Drugs Dermatol. 2011;10(7):710-714.
A Randomized Controlled Trial of a Low-Dose Combined Oral ContraceptiveContaining 3 mg Drospirenone Plus 20 μg Ethinylestradiol in the Treatment of AcneVulgaris: Lesion Counts, Investigator Ratings and Subject Self-Assessment
J. Michael Maloney MD, Peter Dietze Jr. MD, David Watson MD, Minoo Niknian PhD,Sooji Lee-Rugh MD, Carole Sampson-Landers MD, Paul Korner MD MBA| |
Methods: Healthy females (14–45 years old) with moderate facial acne were randomized to 3 mg drsp/20 μg EE 24/4 (n=270) or placebo (n=268) for six cycles. The secondary efficacy variables measured included change from baseline to endpoint (cycle 6) in individual lesion count for nodules, papules, pustules, open and closed comedones.
Results: There were significantly greater reductions in individual lesion counts from baseline to endpoint in the 3 mg drsp/20 μg EE group than in the placebo group (P<0.05 from parametric model).
Conclusion: The 3 mg drsp/20 μg EE COC administered in a 24/4 regimen significantly reduced acne lesions.
Results of a Phase 2, Randomized,Vehicle-Controlled Study Evaluating the Efficacy,Tolerability, and Safety of Daily or Twice Daily SB204 for the Treatment of Acne Vulgaris
Lawrence F. Eichenfield MD,a Linda Stein Gold MD,b Walter K. Nahm MD PhD,c Fran E. Cook-Bolden MD,d and David M. Pariser MDe| |
Tazarotene Cream versus Adapalene Cream in the Treatment of Facial Acne Vulgaris: A Multicenter, Double-Blind, Randomized, Parallel-Group Study
Alan Shalita MD, B. Miller MD, A Menter MD, W. Abramovits MD, K. Loven MD, L. Kakita MD| |
The Efficacy and Tolerability of Tazarotene Foam, 0.1%, in the Treatment of Acne Vulgaris in 2 Multicenter, Randomized, Vehicle-Controlled, Double-Blind Studies
Steven R. Feldman MD PhD,a Cary P. Werner MS,b and Alessandra B. Alió Saenz MDb| |
OBJECTIVE: To evaluate efficacy and tolerability of tazarotene foam, 0.1% in adults and adolescents with acne vulgaris.
METHODS: Two randomized, double-blind, vehicle-controlled, parallel-group studies were conducted at 39 centers in the United States and Canada. The first study involved 744 participants and the second 742, aged 12 to 45 years, who were randomized to receive treatment with either tazarotene foam, 0.1% or vehicle foam once daily for 12 weeks. Lesion counts, Investigator's Static Global Assessments (ISGA), and Subject's Global Assessments (SGA) were evaluated at baseline and weeks 2, 4, 8, and 12. Tolerability was monitored throughout the study.
RESULTS: At week 12 in both studies, treatment with tazarotene foam led to greater decreases from baseline in mean absolute and percentage change in lesion counts (noninflammatory, inflammatory, and total), greater proportion of participants with ≥2-grade improvement in ISGA score, and greater proportion of participants with ISGA score of 0 or 1 than vehicle treatment (P<.001 for all). Only application-site skin irritation and dryness were reported by >5% of participants in active treatment groups in both studies.
LIMITATIONS: The efficacy and tolerability of tazarotene foam were not compared directly with those of other formulations.
CONCLUSION: Tazarotene foam, 0.1% significantly reduced the number and severity of acne lesions after 12 weeks and had a safe and acceptable tolerability profile.
J Drugs Dermatol. 2013;12(4):438-446.
Fitzpatrick Skin Types and Clindamycin Phosphate 1.2%/Benzoyl Peroxide Gel: Efficacy and Tolerability of Treatment in Moderate to Severe Acne
Background: Acne in skin of color is an increasing problem, presenting unique challenges. Although combination therapy is now standard of care in acne, concerns exist with the increased potential irritation and dryness in skin of color. Although individual medications
can be titrated or applied at different times of the day to minimize irritation, this is not always practical or desirable. There is a paucity of
clinical studies that evaluate the safety and efficacy of acne medications in skin of color.
Methods: A post-hoc analysis of efficacy and cutaneous tolerability in 797 subjects receiving clindamycin phosphate 1.2% benzoyl peroxide (BPO) 2.5% gel from two 12-week, multi-center, double-blind studies that enrolled 2,813 subjects with moderate to severe acne. Efficacy, tolerability, and subject satisfaction in Fitzpatrick skin types I-III subjects were compared to subjects with Fitzpatrick skin types IV-VI.
Results: Median reductions in inflammatory lesions were comparable between the two groups. There was a small difference in non - inflammatory and total lesions in favor of those patients with Fitzpatrick skin types I-III (P=0.013 and P=0.024, respectively). Median reductions in inflammatory, noninflammatory, and total lesions at week 12 were 63%, 50%, and 52.4%, respectively for Fitzpatrick skin types I-III and 65%, 47%, and 51.4%, respectively for Fitzpatrick skin types IV-VI. Treatment success was comparable between the two groups and both groups had a high level of subject satisfaction at week 12. Cutaneous tolerability was excellent, with all mean scores less than or equal to 0.2 at week 12 (where 1=mild). Results in the two groups were comparable, although there was slightly more erythema reported in the Fitzpatrick skin types I-III subjects (0.2 versus 0.1). This could be due to the difficulty in vis ualizing erythema in subjects with darker skin.
Conclusions: Acne subjects with Fitzpatrick skin types IV-VI were not found to be more susceptible to cutaneous irritation from treatment with clindamycin phosphate 1.2%/BPO 2.5% gel and both efficacy and tolerability was comparable across the two treatment groups.
J Drugs Dermatol. 2012;11(5):643-648.
Tretinoin Microsphere Gel Pump 0.04% Versus Tazarotene Cream 0.05% in the Treatment of Mildto-Moderate Facial Acne Vulgaris
Leon H. Kircik MD FAAD| |
Efficacy and Safety of Sarecycline, a Novel, Once-Daily, Narrow Spectrum Antibiotic for the Treatment of Moderate to Severe Facial Acne Vulgaris: Results of a Phase 2, Dose-Ranging Study
James J. Leyden MD,a Vilma Sniukiene MD,b David R. Berk MD,b and Alexandre Kaoukhov MDb| |
J Drugs Dermatol. 2018;17(3):333-338.
Alan R. Shalita MD, Guy F. Webster MD PhD, Mitchell S. Wortzman PhD, Diane Nelson BSN MPH| |
Introduction: We Are Making Progress With Both Acne and Rosacea—But, Let’s Face It! We Still Have a Long Way to Go
James Q. Del Rosso DO FAOCD| |
Helen M Torok MDa and Radhakrishan Pillai PhDb| |
Tretinoin is widely used in the treatment of acne. Despite significant advances in formulation development, irritation and dryness can
be particularly bothersome, especially during the first 3-4 weeks, impacting adherence. Dose titration and adjunct use of moisturizers
have been commonly employed. Co-prescribing with benzoyl peroxide (BPO) or a BPO/antibiotic combination is also common
practice. The tretinoin molecule is unstable and can be degraded by BPO, further complicating treatment regimens.
Lately, formulation technology has focused on providing more efficient penetration of the tretinoin into the skin layers so that lower concentrations of tretinoin might afford better tolerability, but maintain good efficacy; incorporating moisturizing excipients to minimize irritation; and providing greater stability to the tretinoin molecule. This approach would be particularly relevant in a pediatric acne population where efficacy/tolerability balance is important and treatment regimens must take into account lifestyles, but little data exist on the use of tretinoin in this patient population.
A micronized formulation of tretinoin (0.05%) gel has been developed that provides a more efficient delivery of tretinoin, because of its optimal particle size, no degradation by BPO and better cutaneous tolerability than tretinoin microsphere (0.1%) gel without compromising efficacy in a pediatric population.
J Drugs Dermatol. 2011;10(6):647-652.
Whitney P. Bowe, MD| |
Joseph B. Bikowsky MD| |
A Comparative Review of the Efficacy and Tolerability of Retinoid-Containing Combination Regimens for the Treatment of Acne Vulgaris
James L. Campbell Jr. MD MS| |
Scott A. Davis MA,a Hsien-Chang Lin PhD,b Cheng-Han Yu MA,c
Rajesh Balkrishnan PhD,d and Steven R. Feldman MD PhDa,e,f
PURPOSE: To characterize the timing of first follow-up visits in US dermatologic practice.
Methods: Patients with a diagnosis of psoriasis, acne, or atopic dermatitis were identified in the 2003-2007 MarketScan Medicaid database. Factors affecting the length of time before first follow-up were assessed using a Cox proportional hazards model.
RESULTS: Mean length of time to the first follow-up visit was 153 days for adults and 142 days for children with psoriasis; 151 days for adults and 218 days for children with acne; and 161 days for adults and 209 days for children with atopic dermatitis. Black and those other than white patients were less likely than whites to receive early follow-up in psoriasis and acne, but more likely in atopic dermatitis. Dermatologists were more likely to schedule early follow-up visits than nondermatologists.
LIMITATIONS: The database includes only Medicaid patients. The rate of non-attendance at scheduled visits could not be determined.
CONCLUSIONS: Most physicians are missing the opportunity to maximize patient adherence by scheduling early follow-up visits. Contact by email or phone may be beneficial for physicians who cannot schedule early follow-up.
J Drugs Dermatol. 2014;13(7):833-836.
James Q. Del Rosso DO FAOCDa and Emil Tanghetti MDb| |
J Drugs Dermatol.2013;12(3 suppl 2):s53-s58.
Do We Really Need Topical Antibiotics in Our New Treatment Paradigm of Acne Vulgaris? A Novel Question to Consider Based on an Updated Model of Pathogenesis
Leon H. Kircik MD| |
Antimicrobial Activity of Pomegranate and Green Tea Extract on Propionibacterium Acnes, Propionibacterium Granulosum, Staphylococcus Aureus and Staphylococcus Epidermidis
Zhaoping Li MD PhD,a,c,d,e Paula H. Summanen MS,a Julia Downes BS,a Karen Corbett BS,a Tomoe
Komoriya PhD,a,e Susanne M. Henning PhD,c,d Jenny Kim MD PhD,a,c,d and Sydney M. Finegold MDa,b,c
J Drugs Dermatol. 2015;14(6):574-578.
Is Topical Dapsone Safe in Glucose-6-phosphate Dehydrogenase-deficient andSulfonamide-allergic Patients?
Guy F. Webster MD PhD| |
Guy F. Webster MD PhD| |
This was a phase 4, 12-week, prospective, nonrandomized, open-label, multicenter study. Approximately 500 patients with mild to moderate acne were treated with TGM 0.04% or 0.1% and assessed for cutaneous irritation at baseline and weeks 3, 6, and 12.
In this post hoc analysis of patients with Fitzpatrick skin type I-III vs Fitzpatrick skin type IV-VI, there was a general trend toward initial worsening of cutaneous adverse events (AEs) by week 3 across all variables and groups. This was followed by a trend toward improvement and resolution of skin-related AEs from week 3 to week 12 regardless of Fitzpatrick skin type, with a few exceptions. Erythema was the only cutaneous AE that consistently decreased among patients with darker skin. Results from a subsequent 3-group analysis (Fitzpatrick I-II vs Fitzpatrick III-IV vs Fitzpatrick V-VI) generally mirrored those from the 2-group study.
Study limitations include patient nonadherence, lack of a placebo arm, and lack of data regarding the impact of concurrent medications on outcomes. There was no correlation between irritation and Fitzpatrick skin type.
ABBREVIATIONS USED: adverse event (AE), analysis of variance (ANOVA), benzoyl peroxide (BP), case report form (CRF), modified Global Acne Grading Score (mGAGS), tretinoin gel microsphere (TGM)
J Drugs Dermatol. 2014;13(6):706-711.
Tazarotene versus Tazarotene plus Clindamycin/Benzoyl Peroxide in the Treatment of Acne Vulgaris: A Multicenter, Double-Blind, Randomized, Parallel-Group Trial
Emil Tanghetti MD, William Abramovits MD, Barry Solomon MD, Keith Loven MD, Alan Shalita MD| |
Benzoyl Peroxide Development, Pharmacology, Formulation and Clinical Uses in Topical Fixed-combinations
Julie C. Harper MD| |
Bilateral Comparison Study of Pimecrolimus Cream 1% and a Ceramide-Hyaluronic Acid Emollient Foam in the Treatment of Patients With Atopic Dermatitis
Topical corticosteroids have been the mainstay of treatment for atopic dermatitis (AD) over the last decade, especially in the setting of acute flares. However, heavy and prolonged use of topical corticosteroid is undesirable as it is associated with side effects such as, skin atrophy, telangiectasia, striae, steroid-induced dermatoses, rosacea, acne exacerbation, and in some severe and rare cases, systemic effects such as hypothalamic-pituitary-adrenal axis suppression, growth retardation and ocular problems. Non-steroidal antinflammatory agents specific for the treatment of AD (topical calcineurin inhibitors, or TCIs) are now available and they are a viable alternative to topical corticosteroids in treating dermatitis of the face, neck, eyelids, and intertriginous areas where there is a greater risk of the steroid-induced side effects. More recently, medical device emollients have entered the marketplace. These medical devices provide, but are not limited to, anti-oxidant, anti-protease, anti-inflammatory activity, and aid in restoring the natural balance of lipids, which is one of the causes of the epidermal abnormalities seen with AD. The present study evaluated the short-term effectiveness and appeal of a non-steroidal medicated device foam as compared to pimecrolimus cream 1% in the treatment of AD within a wide age group of subjects with active disease at baseline. In this study, both pimecrolimus and the medical device foam exhibited efficacy in mild-to-moderate AD. Primary efficacy was measured by IGA. After four weeks of treatment with the medical device foam, 82% of target lesions were scored "clear" (0) or "almost clear" (1) compared to 71% of target lesions under the pimecrolimus arm. This study confirmed that pimecrolimus cream 1% and the medical device foam work well in the treatment of AD in both adults and children with no associated adverse effects.
J Drugs Dermatol. 2011;10(6):666-672.
News, Views, and Reviews. Cutaneous Hyperandrogenism: Role of AntiandrogenTherapy in Acne, Hirsutism, and Androgenetic Alopecia
Aimee Krausz BA and Adam J. Friedman MD| |
Adapalene 0.1% Lotion in the Treatment of Acne Vulgaris: Results From Two Placebo-controlled, Multicenter, Randomized Double-blind, Clinical Studies
Lawrence F. Eichenfield MD,a Michael Jarratt MD,b Joel Schlessinger MD,c Steven Kempers MDd, Vasant Manna MDe, Joyce Hwa RN BSNe, Yin Liu PhDe, Michael Graeber MDe, on Behalf of the Adapalene Lotion Study Group| |
Objectives: To evaluate the efficacy and assess safety of a new adapalene formulation, adapalene 0.1% lotion, versus the lotion vehicle in subjects with acne vulgaris.
Methods: Subjects were randomized to receive either adapalene 0.1% lotion or its vehicle once daily for 12 weeks in two multicenter, randomized, vehicle-controlled, double-blind, parallel group studies. Efficacy was evaluated using two co-primary endpoints: Investigator Global Assessment (IGA) of success rate (defined as the proportion of subjects who achieved at least a two point reduction, on a 5-point scale, from baseline to week 12 in IGA score); and the absolute change from baseline to week 12 in total, inflammatory and non-inflammatory lesions. Signs of local skin irritation and routine clinical safety parameters were evaluated throughout both studies.
Results: In total, 2,141 subjects were included in the two studies: 1,068 patients received adapalene 0.1 percent lotion and 1073 received the vehicle. In both studies, adapalene 0.1% lotion was shown to be significantly more effective than its vehicle in improvement in the IGA success rate. Adapalene 0.1% lotion was also significantly superior to its vehicle in all three lesion reduction measures: total, inflammatory and non-inflammatory. Reports of application site skin irritation in the adapalene 0.1% lotion treatment group were transient and mild or moderate in severity, with only a few being severe. Additionally, according to patient surveys, the lotion formulation was found to be easily spreadable, easily absorbed and pleasant to use.
Conclusion: Adapalene 0.1% lotion used once a day for 12 weeks is effective and well tolerated in the treatment of acne vulgaris.
Background: Some dermatologic disorders are known to be much more common in patients of color, but the leading dermatologic
disorders in patients of color have not yet been described on the basis of nationally representative data.
Purpose: To determine the leading dermatologic disorders for each major racial and ethnic group in the United States.
Methods: We queried the National Ambulatory Medical Care Survey (NAMCS) for the leading diagnoses in patient visits to U.S. dermatologists from 1993 to 2009. The leading diagnoses were tabulated for each racial and ethnic group, and the top conditions were compared between groups. In a separate analysis, visits for skin conditions regardless of physician specialty were analyzed for leading diagnoses in each racial and ethnic group.
Results: The top five diagnoses for African-American patients in dermatology clinics were acne, unspecified dermatitis or eczema, seborrheic dermatitis, atopic dermatitis, and dyschromia. For Asian or Pacific Islander patients, the top five were acne, unspecified dermatitis or eczema, benign neoplasm of skin, psoriasis, and seborrheic keratosis. By contrast, in Caucasian patients, the top five were actinic keratosis, acne, benign neoplasm of skin, unspecified dermatitis or eczema, and nonmelanoma skin cancer. In Hispanic patients of any race, the leading diagnoses were acne, unspecified dermatitis or eczema, psoriasis, benign neoplasm of skin, and viral warts. When the leading dermatologic diagnoses across all physician specialties were assessed, the top diagnoses for African-Americans were unspecified dermatitis or eczema, acne, dermatophytosis of scalp and beard, sebaceous cyst, and cellulitis or abscess; for Asians or Pacific Islanders were unspecified dermatitis or eczema, acne, atopic dermatitis, urticaria, and psoriasis; and for Caucasians were acne, unspecified dermatitis or eczema, actinic keratosis, viral warts, and sebaceous cyst. For Hispanics of any race, they were unspecified dermatitis or eczema, acne, sebaceous cyst, viral warts, and cellulitis or abscess. For a sole diagnosis of a dermatologic condition, only 28.5% of African-Americans' visits and 23.9% of Hispanics' visits were to dermatologists, as compared to 36.7% for Asians and Pacific Islanders and 43.2% for Caucasians.
Limitations: The data are based on numbers of ambulatory care visits rather than numbers of patients. Data on race or ethnicity were not collected for some patients.
Conclusions: Several dermatologic disorders are much more commonly seen in patients of color. Acne and unspecified dermatitis or eczema are in the top five for all major U.S. racial and ethnic groups. There may be an opportunity to improve the care of patients of color by ensuring they have equal access to dermatologists.
J Drugs Dermatol. 2012;11(4):466-473.
Varun Kalhana and Neil Sadick MDb| |
Biologic drugs, a novel class of agents engineered to target specifc mediators of infammation, and small-molecule inhibitors that pen-etrate the cell membrane to interact with targets inside a cell represent the cutting-edge of pharmacological biomedical therapeutics. Clinical studies have already demonstrated the effectiveness of this new generation of drugs in treating a variety of medical illnesses and conditions that were refractory to traditional treatments. This review aims to describe the latest available or currently in-develop-ment drugs, biologic agents, and small molecule inhibitors for treatment of psoriasis, rosacea, alopecia areata, and atopic dermatitis.
J Drugs Dermatol. 2017;16(12):1224-1228
The Sequence of Inflammation, Relevant Biomarkers, and the Pathogenesis of Acne Vulgaris: What Does Recent Research Show and What Does it Mean to the Clinician?
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2013;12(suppl 8):s109-s115.
Lauren Meshkov Bonati MD,a Gorana Kuka Epstein MD,b and Tamara Lazic Strugar MDa| |
INTRODUCTION: Microneedling procedures are growing in popularity for a wide variety of skin conditions. This paper comprehensively reviews the medical literature regarding skin needling efficacy and safety in all skin types and in multiple dermatologic conditions.
METHODS: A PubMed literature search was conducted in all languages without restriction and bibliographies of relevant articles reviewed. Search terms included: “microneedling,” “percutaneous collagen induction,” “needling,” “skin needling,” and “dermaroller.”
RESULTS: Microneedling is most commonly used for acne scars and cosmetic rejuvenation, however, treatment benefit has also been seen in varicella scars, burn scars, keloids, acne, alopecia, and periorbital melanosis, and has improved flap and graft survival, and enhanced transdermal delivery of topical products. Side effects were mild and self-limited, with few reports of post-inflammatory hyperpigmentation, and isolated reports of tram tracking, facial allergic granuloma, and systemic hypersensitivity.
DISCUSS: Microneedling represents a safe, cost-effective, and efficacious treatment option for a variety of dermatologic conditions in all skin types. More double-blinded, randomized, controlled trials are required to make more definitive conclusions.
J Drugs Dermatol. 2017;16(4):308-314.
Raymond L. Garcia MD,a Jerry L. McCullough PhD,b Barry Reece MS MBA,c Frank J. Massino BS LESd| |
Fractionated Delivery Systems for Difficult to Treat Clinical Applications: Acne Scarring, Melasma, Atrophic Scarring, Striae Distensae, and Deep Rhytides
Amy F. Taub MD| |
A Multicenter Study of Topical Azelaic Acid 15% Gelin Combination With Oral Doxycycline as Initial Therapy and Azelaic Acid 15% as Maintenance Monotherapy
Diane M. Thiboutot MD, Alan B. FleischerMD, James Q. Del Rosso DO,Phoebe Rich MD| |
Randomized, Double-Blind, Split-Face Study Evaluating Fractional Ablative Erbium:YAG Laser-Mediated Trans-Epidermal Delivery of Cosmetic Actives and a Novel Acoustic Pressure Wave Ultrasound Technology for the Treatment of Skin Aging, Melasma, and Acne Scars
Macrene Alexiades MD PhDa,b| |
AIM: Evaluate the safety and efficacy of a novel acoustic pressure wave ultrasound device following fractional ablative Er:YAG 2940-nm laser (FELR) and topical agents for rhytids, melasma, and acne scars.
STUDY DESIGN: Randomized, blinded, parallel group split-face side-by-side, controlled study evaluating FELR and topical anti-aging and anti-pigment agents to entire face succeeded by ultrasound to randomized side. Fifteen subjects were enrolled to three treatment arms:rhytids, melasma, and acne scars. Two monthly treatments were administered with 1, 3, and 6 month follow-up. Efficacy was assessed by Comprehensive Grading Scale of Rhytids, Laxity, and Photoaging by Investigator and two blinded physician evaluators. Subject assessments, digital photographs, and reflectance spectroscopic analyses were obtained.
RESULTS: Rhytid severity was reduced from a mean of 3.25 to 2.60 on the 4-point grading scale. Spectrophotometric analysis demonstrated increases in lightness (L*) and reductions in redness (a*) and pigment (b*), with greater improvements on the ultrasound side as compared to FELR and topicals alone. Moderate erythema post-treatment resolved in 7 days and no serious adverse events were observed.
CONCLUSION: In this randomized, paired split-face clinical study, FELR-facilitated TED of topical anti-aging actives with ultrasound treatment is safe and effective with improvement in rhytids, melasma, and acne scars. Statistically significant greater improvement in pigment levels was observed on the ultrasound side as compared to FELR-TED and topical agents alone.
J Drugs Dermatol. 2015;14(11):1191-1198.
Andrew F. Alexis MD MPH,a Fran E. Cook-Bolden MD,b and J.P. York PhDc| |
BACKGROUND: Acne affects individuals of all races and ethnicities; however, lighter and darker skin phototypes face different treatment challenges that may affect treatment response and tolerability. This analysis investigated possible differences in the efficacy and safety of the fixed dose combination of 0.3% adapalene with 2.5% benzoyl peroxide (A/BPO gel 0.3%/2.5%) in subjects with Fitzpatrick Skin Types (FST) I–VI.
METHODS: This was a post-hoc analysis of a Phase 3, multicenter, randomized, double-blind, parallel-group study of moderate to severe acne in subjects with FST I-VI. Subjects received A/BPO gel 0.3%/2.5%, A/BPO gel 0.1%/2.5% (benchmark), or vehicle, once daily for 12 weeks. Efficacy measurements included success rate (IGA of Clear or Almost Clear), change in inflammatory and noninflammatory lesions from baseline to week 12, safety, and tolerability. The intent to treat (ITT) and safety populations were analyzed. Demographics and disposition were analyzed with descriptive statistics; categorical variables by frequency and percentage; and continuous variables with means, medians, minimum, maximum, and standard deviations.
RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 128 subjects with FST I-III, and 89 subjects with FST IV-VI. At week 12, A/BPO gel 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle for all FST and severity groups in inflammatory and noninflammatory lesion reduction (P less than equal to .05). Compared to baseline, 32% of subjects with FST I-III were clear or almost clear, compared to 7% in the vehicle group (P=.001). In FST IV–VI, 28% of subjects were clear or almost clear, compared to 15% for vehicle (P=NS). In all treatment groups and skin phototypes, week 12 tolerability scores were similar to baseline scores, and tolerability scores for most subjects of all skin phototypes were “none” or “mild” for all measures.
SUMMARY: We report that the fixed dose combination of A/BPO gel 0.3%/2.5% is efficacious and safe in patients with FST I-VI with moderate and severe inflammatory acne.
Clinicaltrials.gov registry: NCT01880320
J Drugs Dermatol. 2017;16(6):574-581.
J Drugs Dermatol. 2012;11(3):313-317.
Gary Grove PhD,a Charles Zerweck PhD,a and Jennifer Gwazdauskas MBAb| |
J Drugs Dermatol. 2013;12(6):644-649.
Long-Pulsed Dye Laser-Mediated Photodynamic Therapy Combined with Topical Therapy for Mild to Severe Comedonal, Inflammatory, or Cystic Acne
Alexiades-Armenakas MD PhD| |
Safety and Efficacy of Clindamycin Phosphate 1.2%-Benzoyl Peroxide 3% Fixed-Dose Combination Gel for the Treatment of Acne Vulgaris: A Phase 3, Multicenter, Randomized, Double-Blind, Active- and Vehicle-Controlled Study
Background: Topical fixed-combination therapy containing 1% clindamycin as 1.2% clindamycin phosphate (CLNP) and 3% benzoyl peroxide (BPO) is an effective treatment for acne vulgaris (acne).
Objectives: To demonstrate that the combination of 1.2% CLNP with lower strength BPO (CLNP 1.2%-BPO 3%) in a gel formulation is superior to each individual ingredient, CLNP 1.2% and BPO 3%, and vehicle gel.
Methods: A total of 1,319 patients with acne, aged 12 years or older, were enrolled and randomized (1:1:1:1) to receive CLNP 1.2%-BPO 3%, CLNP 1.2% gel, BPO 3% gel, or vehicle gel once-daily in a 12-week, multicenter, double-blind, parallel-group, vehicle-controlled study. Subjects were evaluated at baseline, weeks 2, 4, 8, and 12 or early termination. Assessment of efficacy was evaluated using a six-point Investigator's Static Global Assessment (ISGA) and Subject's Global Assessment (SGA) of acne severity and lesion counts (inflammatory, non-inflammatory, and total). Safety assessments included skin tolerability and adverse events (AEs).
Results: A greater proportion of subjects who used CLNP 1.2%-BPO 3% gel (39%) had a two grade improvement in ISGA from baseline to week 12 compared with CLNP 1.2% (25%; P<0.001), BPO 3% (30%; P=0.016), and vehicle (18%; P<0.001). CLNP 1.2%- BPO 3% was superior to CLNP 1.2% and vehicle alone in the absolute reduction from baseline to week 12 in all three lesion types (P<0.001 all pair-wise comparisons). CLNP 1.2%-BPO 3% was superior to BPO 3% alone in the absolute reduction from baseline to week 12 in inflammatory (P=0.015) and total (P=0.032) lesion counts. The incidence of product-related AEs was low and similar in all study groups (1% with CLNP 1.2%-BPO 3%, 2% with CLNP 1.2%, 2% with BPO 3%, and 2% with vehicle). Local tolerability assessments showed similar minimal changes from baseline to week 12 in all study groups.
Conclusion: CLNP 1.2%-BPO 3% gel provides superior efficacy to improve ISGA score and reduce inflammatory and total lesion counts compared with the individual active ingredients (CLNP 1.2% and BPO 3%) and vehicle, while maintaining a highly favorable safety and tolerability profile similar to BPO 3% alone.
J Drugs Dermatol. 2011;10(12):1382-1396.
Anne Chapas MD FAAD and Kendra Gail Bergstrom MD FAAD| |
Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials
Angela Moore MD,a Lawrence J. Green MD,b Suzanne Bruce MD,c Neil Sadick MD,d Eduardo Tschen MD MBA,e Philip Werschler MD FAAD FAACS,f Fran E. Cook-Bolden, MD,g Sunil S. Dhawan MD,h Douglass Forsha MD,i Michael H. Gold MD FAAD,j Scott Guenthner MD,k Steven E. Kempers MD,l Leon H. Kircik MD,m Jennifer L. Parish MD,n Marta I. Rendon MD,o Phoebe Rich MD,p Linda Stein-Gold MD,q Stephen K. Tyring MD PhD,r Robert A. Weiss MD FAAD,s Adnan Nasir MD,t Carsten Schmitz MD PhD,u* Terry I. Boodhoo MS,u Alexandre Kaoukhov MD,u,* and David R. Berk MDu| |
A Double-Blind, Randomized, Bilateral Comparison of Skin Irritancy Following Application of the Combination Acne Products Clindamycin/Tretinoin and Benzoyl Peroxide/Adapalene
Renato Goreshi MD, Aman Samrao MD, and Benjamin D. Ehst MD PhD| |
Background: The use of topical medications for acne vulgaris is often limited by their irritant properties. Newer combination preparations are available and offer convenience, but irritant potential may still be a hindrance, perhaps more so with the combination of 2
agents. Few studies have compared these formulations directly for tolerability.
Objective: We sought to compare the tolerability of 2 combination topical acne products, clindamycin 1.2%-tretinoin 0.025% (CLIN/RA) gel and benzoyl peroxide 2.5%-adapalene 0.1% (BPO/ADA) gel.
Methods: CLIN/RA and BPO/ADA were applied daily to opposite sides of a subject's face for 21 days in a double-blinded fashion. Investigators' Global Assessments and study subject self-assessments of burning/stinging, itching, erythema, and dryness/scaling were collected. Transepidermal water loss (TEWL) was also measured as an objective measure of skin irritation. A mixed model analysis and repeated-measures analysis of variance were used to compare outcomes for both acne formulations.
Results: CLIN/RA produced significantly less burning/stinging than BPO/ADA (P<.001) as well as significantly less pruritus than BPO/ADA (P<.001). BPO/ADA caused significantly more TEWL than CLIN/RA (P=.005). There was no significant difference in the amount of erythema or the amount of dryness/scaling caused by either formulation.
Conclusion: CLIN/RA produced significantly less skin irritancy and TEWL than BPO/ADA.
J Drugs Dermatol. 2012;11(12):1422-1426.
A Preliminary Study on the Safety and Efficacy of a Novel Fractional CO2 Laser With Synchronous Radiofrequency Delivery
Robert H. Gotkin MD FACSa,c and Deborah S. Sarnoff MD FAAD FACPb,c| |
J Drugs Dermatol. 2014;13(3):299-304.
Resident Rounds. Part III A. Serendipitous Improvement in Moderate to Severe Acne in Psoriasis Patients Treated With Ustekinumab: A Two-Case Series
J. Daniel Jensen MD,a Thy Huynh BS,a Jennifer Cafardi MD,b and Naveed Sami MDa| |
Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Oral Doxycycline in Subjects With Severe Inflammatory Acne Who Are Candidates for Oral Isotretinoin
James Q. Del Rosso DO,a Linda Stein Gold MD,b Sandra Marchese Johnson MD FAAD,c Maria Jose Rueda MD,d Hilary Baldwin MD,e Edward L. Lain MD,f Megan Landis MD,g Marta Rendon MD,8 Emil Tanghetti MD,9 and Jonathan Weiss MD10| |
J Drugs Dermatol. 2018;17(3):264-273.
Single-Center, Open-Label Study of a Proprietary Topical 0.5% Salicylic Acid-Based Treatment Regimen Containing Sandalwood Oil in Adolescents and Adults With Mild to Moderate Acne
Methods: The investigational regimen consisted of a foaming cleanser, an acne serum, a spot treatment, and a mask. Patients applied the treatment regimen as directed for 8 weeks. The primary ef!cacy measure was the percentage of patients assessed as improved, much improved, or very much improved according to the Global Aesthetic Improvement Scale (GAIS) ratings at week 8. Severity was rated using the Evaluato's Global Severity Scores (EGSS) at baseline and weeks 2, 4, and 8. Tolerability was assessed at baseline and weeks 2, 4, and 8 by asking patients to rate the severity of itching, scaling, erythema, burning, dryness, and stinging. Patients were also asked to complete an acne questionnaire.
Results: 89.4% (42/47) met the primary end point determined by the GAIS of improved (66%), much improved (19%), or very much improved (4%). Notable reductions in lesion counts were observed in patients with more severe or in"amed lesions. Tolerability was queried at all visits. No itching, scaling, or erythema was reported after initial application. Symptoms of intolerability peaked at week 2; however, most events were mild to moderate and were typically reported with use of the mask component. Intolerance decreased by week 4 and by week 8. The treatment regimen was well tolerated by patients.
Conclusions: Results from this study support the use of a proprietary investigational regimen in patients with mild to moderate acne and warrant further investigation to determine whether longer-term therapy (ie, beyond 8 weeks) results in enhanced efficacy with minimal side effects, leading to continued patient compliance and skin improvement.
J Drugs Dermatol. 2012;11(12):1403-1408.
Safety and Efficacy Comparison of Minocycline Microgranules vs Lymecycline in the Treatment of Mild to Moderate Acne: Randomized, Evaluator-blinded, Parallel, and Prospective Clinical Trial for 8 Weeks
Jorge Ocampo-Candiani MD,a Luis Leobardo Velázquez-Arenas MD,a Alberto de la Fuente-García MD,a
Carlos Treviño-Gómezharper MD,b and Arturo Berber MD PhDc
METHODS: 170 participants from 14 to 34 years old with mild to moderate facial acne vulgaris were recruited. 84 had 100 mg of minocycline in a single daily dose for 8 weeks and 86 had 300 mg of lymecycline in a single daily dose for 8 weeks. Participants were evaluated at baseline, week 4 and week 8.
RESULTS: 65 minocycline and 60 lymecycline patients were evaluable. The last observation carried forward for the count of non-inflammatory lesions changed from 37.5 ± 17.8 to 37.7 ± 17.8 in the minocycline group and from 36.9 ± 15.5 to 33.4 ± 19.3 in the lymecycline group (no significant changes); corresponding changes in inflammatory lesions were from 19.4 ± 12.4 to 12.2 ± 10.0 in the minocycline group and from 20.1 ± 11.3 to 12.6 ± 8.4 in lymecycline group (P< 0.05 comparing baseline vs. final in both groups). Porphyrin counts varied from 899.5 ± 613.9 to 233.5 ± 219.5 in the minocycline group and from 956.9 ± 661.8 to 411.8 ± 411.5 in the lymecycline group (P<0.05 between the groups at study end). 36 (42.9%) patients receiving minocycline suffered 55 adverse events (22 of them gastrointestinal), while 28 (33.3%) lymecycline patients had 37 adverse events (15 of them gastrointestinal). One patient in the lymecycline group withdrew the study due to gastritis, and one more patient in the same group experienced eosinophilia.
CONCLUSIONS: There were no differences between the groups in non-inflammatory and inflammatory lesion counts, and in the safety profile. Treatment with minocycline induced statistically significant decrease in facial porphyrin counts compared to the group treated with lymecycline (ClinicalTrials.gov number, NCT00988026).
J Drugs Dermatol. 2014;13(6):671-676.
Emil Tanghetti MD, Leon Kircik MD, David Wilson MD, Sunil Dhawan MD| |
Methods: Patients with acne vulgaris were randomly assigned to receive solubilized BPO 5% gel on one side of the face and a BPO 5%/clindamycin 1% combination product on the contralateral side, twice daily for 4 weeks.
Results: Of 23 patients enrolled, 100% completed the study. Reductions in lesion count with the solubilized BPO gel were at least as great as with BPO/clindamycin—and significantly greater (P≤.05) for noninflammatory lesions at week 1 and inflammatory lesions at week 4. Both regimens were generally well tolerated and patient satisfaction was comparable.
Conclusions: Solubilized BPO 5% gel monotherapy offers significantly greater efficacy, and comparable patient satisfaction, compared with BPO/clindamycin. The early reduction in lesion counts observed with the solubilized BPO gel in the absence of an antibiotic is clinically relevant.
Methods: This study was conducted to assess the effect of systemic isotretinoin on the serum level of folic acid. Sixty-one patients, including 38 women and 23 men (mean age 23.6 ± 6 years) with severe or moderate acne that was resistant to conventional treatments, were supplemented with 0.5 mg/kg/d of oral isotretinoin for 30 days. They were instructed not to use any other drugs having an effect on the folic acid level nor change their diet. The serum levels of folic acid were measured at the baseline and at the end of the treatment period. Statistical analyses were carried out using the paired t test.
Results: Mean levels of folic acid were 26.75 ± 9.42 nmol/L at baseline, and and 23.6 ± 8.42 nmol/L after 30 days of isotretinoin supplementation. This showed a significant decrease in the serum level of folic acid (P=.008).
Conclusion: Given the significant decrease in the serum level of folic acid following a 30-day use of oral isotretinoin in acne patients, and considering the important role of folic acid in metabolic functions, we recommend further studies to assess the effect of longer periods of isotretinoin treatment, in addition to studies including other relevant factors in folic acid metabolism (e.g., serum homocysteine levels). Moreover, folic acid supplementation in acne patients using isotretinoin is recommended.
J Drugs Dermatol. 2012;11(9):e23-e24.
Effects Of Benzoyl Peroxide 5% Clindamycin Combination Gel Versus Adapalene 0.1% on Quality of Life In Patients With Mild to Moderate Acne Vulgaris: A Randomized Single-blind Study
Background: Patients with acne vulgaris often have impaired quality of life (QOL). The fixed-dose combination of benzoyl peroxide 5%/clindamycin
1% gel (BPO/C) topical gel provides an earlier onset of action and is more effective against inflammatory and total facial lesions than adapalene
(AP) 0.1% gel.
Objective: To compare BPO/C and AP with regard to the early effect on QOL, efficacy, and tolerability in patients with mild to moderate acne vulgaris.
Methods: Patients were randomized to BPO/C or AP once nightly for 12 weeks in a multicentre, single-blind trial. The primary efficacy endpoint was QOL at week 2, assessed using the Skindex-29 questionnaire. Secondary endpoints included grading and counting of acne lesions; investigator assessments of peeling, erythema, and dryness, and patient-reported burning or itching. Adverse events were monitored during the study and during the 14-day minimum follow-up period.
Results: A total of 168 patients were enrolled, and 114 patients completed the study. In the intent-to-treat population, after 2 weeks of treatment, BPO/C was associated with a small but noticeably better improvement in global QOL compared with AP (-4.9 versus -1.1; P<0.001). A greater reduction in both total and inflammatory lesions was noted from week 1 onward (P<0.05) with BPO/C versus AP. At all time points, BPO/C was better tolerated than AP for all investigator-rated (dryness, peeling, erythema) and patient-rated (burning, itching) events (P<0.036).
Conclusions: BPO/C is associated with early improvements in QOL compared with AP. These QOL improvements are likely to be the result of better efficacy and tolerability outcomes observed with BPO/C.
J Drugs Dermatol. 2012;11(6):714-722
Short-Term Combination Therapy and Long-Term Relapse Prevention in the Treatment of Severe Acne Vulgaris
J Drugs Dermatol. 2012;11(2):174-180.
A Split-Faced, Observer-Blinded Comparison Study of Topical Adapalene/Benzoyl Peroxide and Adapalene in the Treatment of Asian Acne Patients
Won-Jeong Kim MD, aJung-Min Park MD,a Hyun-Chang Ko MD,a,b Byung-Soo Kim MD PhD,a,c Moon-Bum Kim MD PhD, a,c and Margaret Song MDa| |
Skin Through the Ages: State-of-the-Art Options for the Topical Treatment of Acne, Photodamage, and Aging
Treatment Response With Once-Daily Topical Dapsone Gel, 7.5% for Acne Vulgaris: Subgroup Analysis of Pooled Data from Two Randomized, Double-Blind Stu
Zoe Diana Draelos MD,a David A. Rodriguez MD,b Steven E. Kempers MD,c Suzanne Bruce MD,d Marina I. Peredo MD PC,e Jeanine Downie MD,f Joan-En Chang-Lin PhD,g David R. Berk MD,g Shiling Ruan PhD,g and Alexandre Kaoukhov MDg| |
BACKGROUND: Acne vulgaris has varying physical and psychological effects in men and women of different ages, races, and ethnicities.
OBJECTIVE: This analysis assessed the relationship of age, sex, and race to treatment response with once-daily topical dapsone gel, 7.5%.
METHODS: We conducted a pooled subgroup analysis of 2 randomized, double-blind, vehicle-controlled clinical trials conducted in the US and Canada. The studies included patients with 20 to 50 inflammatory and 30 to 100 noninflammatory facial lesions, and a Global Acne Assessment Score (GAAS) of 3 (moderate). Pooled data (N=4340) were analyzed by age (12–17 and ≥18 years), sex, and race (Caucasian and non-Caucasian) for GAAS success (score of 0 [none] or 1 [minimal]) and mean percent change from baseline in inflammatory, noninflammatory, and total lesion counts. The impact of age and sex on treatment response was examined using multivariate analysis. Adverse events were analyzed by subgroups.
RESULTS: Treatment responses with dapsone gel, 7.5% were greater overall and for all subgroups versus vehicle. GAAS success rates and mean decrease in all lesion counts with dapsone gel, 7.5% were greater in older (aged ≥18 years) versus younger patients, and for females versus males. Treatment response with dapsone gel, 7.5% in racial subgroups was similar. Multivariate analysis showed statistical significance for age group and sex as predictors of GAAS success (P less than equal to .005) and reduction in lesion counts (P less than equal to .025). Adverse events were similar across subgroups.
CONCLUSIONS: Older age (≥18 years) and female sex were predictors of treatment response. These subgroups tended to have greater acne improvement in subgroup comparisons. Caucasian and non-Caucasian patients had similar responses. The safety profile of dapsone gel, 7.5% was similar across subgroups.
J Drugs Dermatol. 2017;16(6):591-598.
Beneficial Effect of a Moisturizing Cream as Adjunctive Treatment to Oral Isotretinoin or Topical Tretinoin in the Management of Acne
Sabine Laquieze MD, Janusz Czernielewski MD, Marie-José Rueda MD| |
Comparing a Novel Solubilized Benzoyl Peroxide Gel With Benzoyl Peroxide/Clindamycin: Final Data From a Multicenter, Investigator-Blind, Randomized Study
Leon Kircik MD, Lawrence Green MD, Diane Thiboutot MD, Emil Tanghetti MD, David Wilson MD,Sunil Dhawan MD, Lisa Parr PharmD| |
Introduction: A solubilized 5% BPO gel has been developed to enhance the bioavailability, follicular penetration, and efficacy of BPO.
Methods: Sixty-five patients with moderate facial acne vulgaris were randomly assigned to apply solubilized 5% BPO gel to one facial side and 5% BPO/1% clindamycin to the contralateral side, twice daily for four or 12 weeks.
Results: The solubilized BPO gel resulted in significantly greater reductions in non-inflammatory lesion count than BPO/clindamycin at weeks 1, 2, 3, 4 and 12 and comparable reductions in inflammatory lesion count at all time points. Mean values for patient satisfaction with acne improvement were comparable and mean levels of erythema, dryness, peeling, stinging/burning and itching were consistently less than mild.
Conclusion: Compared with BPO/clindamycin, the solubilized BPO gel offers significantly greater reductions in non-inflammatory lesion count and comparable reductions in inflammatory lesion count in the absence of an antibiotic.
Treatment of CO2 Laser Induced Hypopigmentation With Ablative Fractionated Laser Resurfacing: Case Report and Review of the Literature
Emily P. Tierney MD and C. William Hanke MD MPH| |
A Randomized, Investigator-Blinded Trial to Assess the Antimicrobial Efficacy of aBenzoyl Peroxide 5%/Clindamycin Phosphate 1% Gel Compared With a Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel in the Topical Treatment of Acne Vulgaris
J. Mark Jackson MD, Juian-Juian Jan Fu MD PhD, Jennifer Almekinder BS| |
Methods: This 16-week, two-center, investigator-blinded, randomized, parallel-group study evaluated the antimicrobial efficacy of clindamycin phosphate 1%/benzoyl peroxide 5% gel (BPO/C) as compared to a clindamycin phosphate 1.2%/tretinoin 0.025% gel (T/C) over 16 weeks in the treatment of moderate to moderately severe acne.
Results: While subjects in both arms experienced reductions in total Propionibacterium acnes (P. acnes) counts, the BPO/C arm produced greater reductions throughout the study. Furthermore, overall reductions in the number of clindamycin-resistant and erythromycin- resistant P. acnes occurred only in BPO/C treated subjects.
Conclusion: These data suggest that clindamycin phosphate 1%/benzoyl peroxide 5% gel reduces P. acnes counts and mitigates the emergence of antimicrobial resistance.
Michael T. Jarratt MD,a Terry M. Jones MD,b Joan-En Chang-Lin PhD,c Warren Tong PharmD MS,c David R. Berk MD,c Vince Lin PhD,c and Alexandre Kaoukhov MDc| |
J Drugs Dermatol. 2016;15(10):1250-1259.
Cumulative Irritation Potential of Metronidazole Gel Compared to Azelaic Acid Gel after Repeated Applications to Healthy Skin
Kristin Ziel MS IV, Christopher B. Yelverton MD MBA, Rajesh Balkrishnan PhD, Steven R. Feldman MD PhD| |
Objective: To assess the cumulative irritation potential of metronidazole 0.75% gel and azelaic acid 15% gel.
Methods: Metronidazole 0.75% gel, azelaic acid 15% gel, and a white petrolatum negative control were applied under occlusive conditions to the upper back of a total of 33 healthy subjects. There were twelve 24-hour applications (4 times a week) and three 72-hour applications on weekends during a 3-week period. Skin reactions (erythema score ± other local reaction) were assessed within 15 to 30 minutes of removal of the products.
Results: The mean cumulative irritancy index of metronidazole 0.75% gel was significantly lower than that of azelaic acid 15% gel and not significantly higher than the negative control product. There was increasing cumulative irritancy with azelaic acid; no cumulative irritancy was seen for either metronidazole or white petrolatum.
Conclusion: Metronidazole 0.75% gel is less irritating in sustained use than azelaic acid 15% gel.
Efficacy of Benzoyl Peroxide (5.3%) Emollient Foam and Benzoyl Peroxide (8%) Wash in Reducing Propionibacterium acnes on the Back
James J. Leyden MD| |
Objectives: To evaluate the effectiveness of BP (5.3%) emollient foam and BP (8%) wash in reducing P. acnes levels on the back.
Methods: Five-week open-label single-center study of 20 healthy subjects (>18 years old), colonized with P. acnes on their backs (>10,000 colonies per cm2). Subjects were treated once daily with BP (5.3%) foam for two weeks; no treatment in week 3, and BP (8%) wash once daily for two further weeks. Quantitative bacteriologic cultures obtained at baseline and weeks 1, 2, 3, 5 and 6. Results: Nineteen evaluable patients. Total P. acnes counts were reduced by 1.9 log (one week) and 2.1 log (two weeks) with BP (5.3%) emollient foam. BP (8%) wash did not reduce P. acnes counts after two weeks.
Discussion: BP (5.3%) emollient foam was superior to BP (8%) wash in reducing P. acnes on the back. The lack of effect of BP (8%) wash is surprising in view of the demonstrated results on the face and warrants further study.
The Development and Optimization of a Fixed Combination of Clindamycin and Benzoyl Peroxide Aqueous Gel
Daniel Bucks PhD, Pramod Sarpotdar PhD,Karen Yu PhD, Arturo Angel BS,James Del Rosso DO| |
Yaxian Zhen MD PhD, Marianne Stoudemayer RN, George Vamvakias, Albert M. Kligman MD PhD| |
Holly Bartell, Brian L. Ransdell MD, Asra Ali MD| |
Sewon Kang MD,a Vicente Torres Lozada MD,b Vincenzo Bettoli MD,c Jerry Tan MD,d Maria Jose Rueda MD,e Alison Layton MB ChB,f Lauren Petit BS,g and Brigitte Dréno MD PhDh| |
OBJECTIVES: Evaluate classification for atrophic acne scars by shape, size, and facial location and establish reliability in assessments.
METHODS: We conducted a non-interventional study with dermatologists performing live clinical assessments of atrophic acne scars. To objectively compare identification of lesions, individual lesions were marked on a high-resolution photo of the patient that was displayed on a computer during the clinical evaluation. The Jacob clinical classification system was used to define three primary shapes of scars 1) icepick, 2) boxcar, and 3) rolling. To determine agreement for classification by size, independent technicians assessed the investigators’ markings on digital images. Identical localization of scars was denoted if the maximal distance between their centers was ≤ 60 pixels (approximately 3 mm). Raters assessed scars on the same patients twice (morning/afternoon). Aggregate models of rater assessments were created and analyzed for agreement.
RESULTS: Raters counted a mean scar count per subject ranging from 15.75 to 40.25 scars. Approximately 50% of scars were identified by all raters and ~75% of scars were identified by at least 2 of 3 raters (weak agreement, Kappa pairwise agreement 0.30). Agreement between consecutive counts was moderate, with Kappa index ranging from 0.26 to 0.47 (after exclusion of one outlier investigator who had significantly higher counts than all others). Shape classifications of icepick, boxcar, and rolling differed significantly between raters and even for same raters at consecutive sessions (P<.001 and P=0.4, respectively). Analysis showed only 65% of scars were identical in both sessions. We also found that there is a threshold of detection in terms of size, with poor agreement among investigators for very small scars (<2 mm). The repeatability of identification of scars ≥ 2.0 mm was acceptable, and we found that increasing scar size was positively correlated with agreement. Reliability was improved when only scars >2 mm were included. For smaller scars (<2 mm), inter-rater reliability was poor.
CONCLUSIONS: While intuitively it makes sense that describing scar morphology could guide treatment, we have shown that shape-based evaluations are subjective and do not readily yield strong agreement. Until there is a more objective way to evaluate morphology that is readily available to practicing clinicians, we propose that size should be considered a primary characteristic for scar classification systems. We further suggest classification of <2 mm, 2-4 mm, and >4 mm based on how the size would likely affect diagnostic and therapeutic choices. Finally, we recommend that scars <2 mm not be included in a clinical classification but should be evaluated by an objective method that may be refined in the future.
J Drugs Dermatol. 2016;15(6):693-702.
Lisa A. Carroll, MD and Anne E. Laumann, MD| |
Amanda A. Cyrulnik MD,a,b,* Aron J. Gewirtzman MD,a,c,* Karin Blecher Paz MD,a Jaimie B. Glick MD,b
Anika K. Anam MD,b Daniel A. Carrasco MD,c Alan R. Shalita MD,b and Steven R. Cohen MD MPHa
OBJECTIVE: To evaluate the information acquired and stored within iPLEDGE as it compares to medical charts with a goal of assessing the efficacy of iPLEDGE as a database.
METHODS: This is a multicenter retrospective chart review analyzing congruence and discrepancies between medical chart documentation and iPLEDGE data for all patients who received at least a single dose of isotretinoin from the primary investigators between January 2006 and November 2010.
RESULTS: A total of 357 charts were analyzed. Overall congruence between medical chart documentation and iPLEDGE data was observed in only 73.1% of cases. The discrepancy (N=96) was due to a missed dose (prescription recorded in chart but not in iPLEDGE) in 81.4% of cases, or an addition (medication dispensed per iPLEDGE without corresponding chart documentation) in the remainder of cases. Of note, several charts had multiple discrepancies (N=249 total discrepancies).
LIMITATIONS: Retrospective chart review study.
CONCLUSION: Given the large percentage of discordant data, our findings question the efficacy of the iPLEDGE system, which is designed to monitor every dispensed isotretinoin dose.
J Drugs Dermatol. 2016;15(1):97-102.
Aikaterini I. Liakou MD,a Michael J. Theodorakis MD,b Bodo C. Melnik MD PhD,c
Apostolos Pappas PhD,d and Christos C. Zouboulis MD PhDa
METHODS: Nutritional clinical studies in dermatology have been reviewed using the MedLine literature source and the terms "diet" or "nutrition" and "skin".
RESULTS & CONCLUSIONS: The data on the relationship between nutrition and skin are until now controversial and much more work is needed to be done to clarify possible etiological correlations.
J Drugs Dermatol. 2013;12(10):1104-1109.
The Effect of Benzoyl Peroxide 9.8% Emollient Foam on Reduction of Propionibacterium acnes on the Back Using a Short Contact Therapy Approach
Benzoyl peroxide (BP) exerts its therapeutic effect for acne vulgaris through reduction of Propionibacterium acnes. A 1.0 to 2.0 log reduction in P acnes has been demonstrated primarily on the face with use of “leave-on” BP formulations, but also with some BP cleansers. In addition to use for facial acne vulgaris, cleanser formulations of BP are commonly used for truncal acne vulgaris due to ease of use on a large body-surface area and to avoid bleaching of fabric. To date, evaluation of P acnes reduction on the trunk has not been well studied with BP formulations, especially with the use of recognized and standardized methods to accurately determine P acnes colony counts. A previous study demonstrated that a BP 8% cleanser did not reduce counts of P acnes on the back when subjects were instructed to apply the cleanser in the shower, allow it to dry for 20 seconds on the skin, and then rinse off the cleanser. Evaluation of specified time intervals between application on the back and rinsing with BP formulations would help to better define the necessary skin contact time associated with high reductions of P acnes (>90%), recognizing also the potential roles of BP concentration and vehicle. This 2 week study using quantitative bacteriologic cultures evaluates the effectiveness of BP 9.8% emollient foam in reducing P acnes levels on the back with 2 minutes of skin contact time and compares results with a BP 5.3% “leave-on” emollient foam formulation. Short contact therapy utilizing a 2 minute skin contact time with BP 9.8% emollient foam used once daily over a 2 week duration was highly effective in reducing the quantity of P acnes organisms on the back and provided comparable colony count reduction to “leave on” therapy using BP 5.3% emollient foam.
J Drugs Dermatol. 2012;11(7):830-833.
C. Ryan Kirkland MD, Christopher B. Yelverton MD MBA, Alan B. Fleischer Jr. MD, Fabian T. Camacho MS, Steven R. Feldman MD PhD| |
Purpose: To determine whether a metronidazole gel formulation is more or less irritating to the skin compared to metronidazole creams.
Methods: A total of 32 normal, healthy volunteers were tested using irritancy patches with 0.75% metronidazole gel and cream, 1% metronidazole cream, and petrolatum (used as the “negative control”). Blinded observers evaluated the application sites for signs of irritancy. A numerical score was assigned to these irritancy patch sites each day for 21 days, or until significant irritation developed, and cumulative irritancy scores were calculated for the study period. A mixed model of variance analysis was performed.
Results: After 21 days of evaluation, analysis of the mean cumulative irritancy scores for each of the agents used showed there to be no statistical difference in irritancy potential between the metronidazole gel and the metronidazole creams.
However, the 1% metronidazole cream was significantly more irritating than petrolatum. Conclusion: There was no significant difference in the cumulative irritancy potential of cream and gel preparations of metronidazole. The irritancy of topical formulations for treating rosacea should be considered on a case by case basis.
Biophysical Evaluation of Fractional Laser Skin Resurfacing With an Er:YSGG Laser Device in Japanese Skin
Background: Ablative fractional laser skin resurfacing (FLSR) has recently been used for the amelioration of acne scars, and previous
studies have shown clinical effectiveness. Despite its extensive use, few studies have focused on the associated changes in biophysical
properties of the epidermis. Herein, we evaluate transepidermal water loss, sebum levels, skin hydration, and skin elasticity, following
FLSR treatments with an Er:YSGG laser device (Pearl FractionalTM , Cutera Inc., Brisbane, CA), employing non-invasive measurements.
Methods: Five Japanese patients with facial acne scars underwent one FLSR session. Some acne scars appeared to become less obvious as a consequence of the treatment. All patients were aware of a feeling of skin tightness in treated areas.
Results: Objective measurements on the lower lateral angle of the eye and on the inner cheeks were evaluated at baseline and at 3 days, 1 week, and 4 weeks after FLSR. Transepidermal water loss showed a significant two-fold (100%) increase at day 3, but had returned to almost the baseline level at week 4 in both areas. Sebum secretion showed a 50% increase at day 3, but had returned to the baseline level after day 7. Skin hydration showed a significant decrease at day 3, but had returned to the baseline level by day 7, and showed significant improvement at the end of the study. Skin elasticity (R2) was still at baseline on day 3, but showed some improvement—an increase of at least 30%—at the end of the study.
Conclusions: Based on our findings, we believe that FLSR should be performed no more than once a month to allow sufficient time for the damaged skin to recover its barrier function in most areas of the face.
J Drugs Dermatol. 2012;11(5):637-642.
Successful Treatment of Rhinophyma With Fractionated Carbon Dioxide (CO2) Laser in an African-American Man: Case Report and Review of Literature of Fractionated CO2 Laser Treatment of Rhinophyma
Ekaterina Kraeva BSN,a,b Derek Ho BS,a,b and Jared Jagdeo MD MSa,b,c| |
Efficacy and Safety of Clindamycin-Tretinoin Gel Versus Clindamycin or Tretinoin Alone in Acne Vulgaris: A Randomized, Double-Blind,Vehicle-Controlled Study
Background: Topical combination therapy containing a retinoid and an antimicrobial is an effective treatment for acne vulgaris.
Objective: To evaluate the efficacy and safety of a new topical formulation containing clindamycin phosphate 1.2% and tretinoin 0.025% solubilized in an aqueous-based gel (CT gel).
Methods: 1,649 participants were randomized 2:2:2:1 to 12 weeks of double-blind treatment with CT gel, clindamycin, tretinoin, or vehicle gel administered once daily.
Results: Significantly more participants achieved 2-grade or greater improvement on the Investigator's Static Global Assessment score with CT gel versus clindamycin, tretinoin, or vehicle gel. CT gel produced a significantly greater reduction in absolute number of total lesions versus all other treatment groups, in total and noninflammatory lesions versus clindamycin, and in total and inflammatory lesions versus tretinoin. Local tolerability was similar to that of tretinoin alone; signs and symptoms of irritation were most notable at week 2. There were no more adverse events with CT gel than with tretinoin gel.
Conclusion: CT gel is more effective than clindamycin or tretinoin monotherapy, with a safety and tolerability profile similar to that of tretinoin.
J Drugs Dermatol. 2012;11(3):318-326.
Only Skin Deep: Optimism and Public Self-Consciousness Did Not Associate With the Placebo Response in a Dermatology Clinical Trial
Marisa Kardos Garshick MD,a Anne Lynn S. Chang MD,b and Alexandra Boer Kimball MD MPHa| |
METHODS: A questionnaire was mailed to subjects previously enrolled in a two-center rosacea study who had been randomized to either a treatment or placebo gel. The questionnaire included the Revised Life Orientation Test (LOT-R), the Public Self-Consciousness Scale, and questions to assess personality traits.
RESULTS: Forty-seven subjects out of 83 (57%) returned the questionnaire. There was no statistically significant difference in the LOT-R score in those who responded to placebo versus those who did not (18.08 vs 17.92, P= 0.92) nor in those who responded to active treatment versus those who did not (16.27 vs 15.86, P= 0.79). There was no statistically significant difference in public-self consciousness among placebo or active treatment responders versus non-responders (11.75 vs 10.67, P=0.66; 13.55 vs 14.45, P= 0.68). The placebo responders were more likely to report that they were not unusually sensitive to most drugs/medications (X2= 8.33, P= 0.004).
CONCLUSION: Although this pilot study is small, there was no meaningful difference in levels of optimism or public self-consciousness among those who responded to placebo. Placebo responders were more likely to report that they were not sensitive to most drugs/medications, raising the possibility that they are actually less likely to detect when they are on medications.
J Drugs Dermatol. 2014;13(6):719-722.
Jennifer Soung MD, Justine Cohen BA, Robert Phelps MD, Steven R. Cohen MD MPH| |
Martin Ray MDa and Michael Gold MDb| |
J Drugs Dermatol. 2015;14(11):1268-1271.
Effect of Systemic Isotretinoin Therapy on Mucociliary Clearance and Nasal Surface Mucosa in Acne Patients
Zennure Takci MD,a Gulcin Guler Simsek MD,b Hayriye Karabulut MD,c
Yunus Buran MD,c and Ayse Serap Karadag MDd
METHODS: A total of 30 patients with severe or moderate acne were enrolled in this study. The median prescribed dose of isotretinoin was 0.75 mg per kg per day. Clinical and biochemical examinations were carried out periodically. The ST and nasal cytology were performed before treatment and during the third month of therapy.
RESULTS: Of the 30 patients who initially agreed to participate in the research, 21 completed the study (18 female and 3 male, mean ± standard deviation (SD) aged 20.9 ± 4.7 years, range 15-32 years). There was a significant difference between the mucociliary clearance time for subjects in the pre- and post-treatment periods (173.8 ± 89.2 seconds vs 245.2 ± 191.6 seconds, respectively; P=.009). Cytological examination revealed that the squamous cell ratio was significantly lower and the reactive changes of the respiratory epithelium were significantly higher 3 months after isotretinoin therapy than before therapy (P=.010, P=.002, respectively). There were mild signs of inflammation according to the number of neutrophilic leukocytes (8.3% vs 26.6%, P=.06) after 3 months of isotretinoin therapy.
CONCLUSION: Systemic isotretinoin alters the mucociliary transport, decreases the squamous cell ratio, increases the reactive changes in the respiratory epithelium significantly, and increases neutrophils in the nasal surface mucosa in the third month of treatment.
J Drugs Dermatol. 2013;12(8):e124-e128.
Background: South Asians represent a rapidly growing part of the U.S. population, increasing 188 percent from 1990 to 2000 (0.27% to 0.78%). Studies investigating the epidemiology of skin disorders in South Asian Americans are lacking.
Objective: We sought to determine common skin conditions and concerns among this population.
Methods: This was a community-based survey study. The IRB-approved survey tool was distributed to South Asians adults in the New York City area. All data was self-reported.
Results: 190 surveys were completed. 54 percent of responders were female and 46 percent were male. The age of participants ranged from 18-74 years. The respondents were predominantly foreign born (76%), but a large minority (32%) reported living in the U.S. for over 20 years. Nearly half (49%) of the study population reported having visited a dermatologist in the past. The five most common dermatologic diagnoses included: acne (37%), eczema (22%), fungal infection (11%), warts (8%) and moles (8%). The five most common concerns included: dry skin (25%), hair loss (22%), uneven tone (21%), dark spots (18%) and acne (17%).
Conclusions: Our results suggest that the leading skin conditions and concerns in South Asian Americans are similar to those reported in other populations with skin of color.
J Drugs Dermatol. 2011;10(5):524-528.
Grace Sun MD, Carina A. Wasko MD, Sylvia Hsu MD| |
J Drugs Dermatol. 2013;12(10):1177-1179.
Kelly K. Park MD, Rebecca C. Tung MD, Arlene Ruiz de Luzuriaga MD MPH| |
The Phototoxic and Photoallergy Potential of Clindamycin Phosphate 1.2%/ Tretinoin 0.025% Gel for Facial Acne: Results of Two Single-Center, Evaluator-Blinded, Randomized, Vehicle-Controlled Phase 1 Studies in Healthy Volunteers
John Murray MDa and Aaron Potts BScb| |
OBJECTIVES: Two-phase I studies were conducted to evaluate the phototoxic and photoallergic potential of clindamycin/tretinoin gel.
METHODS: Study 1 (phototoxic) (n=37) and Study 2 (photoallergic) (n=58) were single-center, evaluator-blinded, randomized, vehicle-controlled, phase 1 studies conducted in healthy volunteers. In Study 1, clindamycin/tretinoin gel patches, vehicle gel patches and blank patches (no gel) were applied concurrently for 24 hours to naïve sites. After patch removal, sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) then 0.75 minimal erythema dose (MED) of UVA/ultraviolet B light (UVB), the same irradiation protocol followed by 15 joules/cm2 of visible light (VIS), or served as non-irradiated controls. Study 2 examined the effect of repeated drug exposure and involved an induction period (6 repeat phases at the same body sites during which clindamycin/tretinoin gel and vehicle gel patches were applied for 24 hours, removed and sites irradiated with UVB +/- VIS), followed by a rest period (10 to 17 days), then a challenge period that used the protocol described for Study 1. In both studies, inflammatory responses and other cutaneous effects were evaluated at 1, 24, 48, and 72 hours after patch removal.
RESULTS: No subject experienced any adverse events in Study 1 (phototoxic). One subject in Study 2 (photoallergic) experienced AEs (diffuse erythema; mild application site irritation at one each of UV/VIS-irradiated clindamycin/tretinoin gel and vehicle gel patch sites) considered definitely related to study product that resulted in discontinuation from the study. Data from Study 1 and the challenge phase from Study 2 showed most subjects had no visible inflammatory reaction to clindamycin/tretinoin gel after irradiation.
CONCLUSIONS: Clindamycin/tretinoin gel has a favorable safety profile following UV/visible irradiation and a low potential for phototoxicity and photoallergenicity.
J Drugs Dermatol. 2014;13(1):16-22.
Stacy Smith MD, Vera Morhenn MD, Guy Webster MD| |
Elaine Shnitkind MD, Yaping E PhD, Susan Geen, Alan R. Shalita MD, Wei-Li Lee PhD| |
Inhibition of Propionibacterium acnes by Bacteriocin-Like Inhibitory Substances (BLIS) Produced by Streptococcus salivarius
Jennifer C. Filip BA, Whitney P. Bowe BS, Joseph M. DiRienzo PhD, Alla Volgina MSc, David J. Margolis MD PhD| |
Kenneth Beer MD, Hillary Oakley PAC, Jill Waibel MD| |
Efficacy of Microdermabrasion Preceding ALA Application in Reducing the Incubation Time of ALA in Laser PDT
Bruce E. Katz MD, Sarah Truong MD, Diane C. Maiwald MD, Kathryn E. Frew MD, Dean George MD| |
Ablative Fractionated CO2 Resurfacing Yields Excellent Result for Severely Atrophic Traumatic Scar on the Face
J. Daniel Jensen MD, Cooper Keane MD, Conway C. Huang MD, and Marian E. Northington MD| |
J Drugs Dermatol. 2014;13(7):861-862.
Aanand N. Geria MD, Christina N. Lawson MD, Rebat M. Halder MD| |
J Drugs Dermatol. 2011;10(5):483-489.
Kimberly K. Schulz MD and Hobart W. Walling MD PhD| |
David A. Kasper DO MBA, Joel L. Cohen MD, Aradhna Saxena MD, Greg S. Morganroth MD| |
Soloman Shockman MD, Kapila V. Paghdal MD PharmD, George Cohen MDb| |
Effect of GT-Peptide 10 and Triethyl Citrate on P. acnes Biofilm Formation, Viability, and Dispersion
Hinnerk Eilers PhD and Oleg A. Alexeyev MD PhD| |
OBJECTIVE: To investigate the efficacy of GT peptide 10 either alone or in combination with triethyl citrate (TEC) in in vitro model of P. acnes biofilm.
METHODS: Six-day-old P. acnes biofilms were treated with various concentrations of these substances and biofilm dispersion and cell viability were monitored.
RESULTS: A 24-hour exposure of preformed biofilms to a combination of GT peptide 10/TEC led to killing of up to 92% of bacterial cells inside the biofilm. Neither the single substance nor the combination of both substances affected the biofilm integrity or resulted in biofilm dispersal.
CONCLUSIONS: A combination of GT peptide 10/TEC shows antibacterial effects in in vitro model of P. acnes biofilm.
J Drugs Dermatol. 2016;15(6):778-781.
Stephen F. D'Addario, MD; Matthew E. Bryan, MD; Warren A. Stringer, MD and Sandra Marchese Johnson, MD| |
aPeter K. Lee MD PhD and bAndrew Kloser PhD| |
J Drugs Dermatol. 2013;12(8):925-930.
Clinical Relevance of Skin Barrier Changes Associated With the Use of Oral Isotretinoin: The Importance of Barrier Repair Therapy in Patient Management
James Q. Del Rosso DO FAOCD| |
J Drugs Dermatol. 2013;12(6):626-631.
Mary L. Stevenson MD,a Julie K. Karen MD,a,b and Elizabeth K. Hale MDa,b| |
Photodynamic therapy (PDT) uses a topical photosensitizing agent which is activated by a light source to cause destruction of specific cells. Commonly used for the treatment of actinic keratoses and photodamage, PDT can also be used for other conditions including acne and sebaceous hyperplasia. Here we report our experience with two treatment protocols. The first protocol utilizes laser assisted delivery of topical 5-aminolevulinic acid for enhanced efficacy of blue light photodynamic therapy in the treatment of actinic keratoses and photodamage. The second protocol utilizes red light photodynamic therapy followed by pulsed dye laser to effectively target sebaceous glands in patients with extensive sebaceous hyperplasia.
J Drugs Dermatol. 2017;16(4):329-331.
Whitney P. Bowe MD, Magdalene A. Dohil MD, Alan C. Logan ND, Andrew F. Alexis MD MPH| |
Neal Bhatia MD| |
J Drugs Dermatol. 2013;12(7):796-798.
Gina R. Chacon MD, David J. Wolfson MD, Carlos Palacio MD, Animesh A. Sinha MD PhD| |
Spotlight on the Use of Nitric Oxide in Dermatology: What Is It? What Does It Do? Can It Become an Important Addition to the Therapeutic Armamentarium for Skin Disease?
James Q. Del Rosso DO FAOCD FAADa,b,c and Leon Kircik MDd,e,f,g| |
The Treatment of Inflammatory Facial Dermatoses With Topical Corticosteroids:Focus on Clocortolone Pivalate 0.1% Cream
Methods: Clocortolone pivalate 0.01% cream was applied to affected facial skin in subjects presenting with seborrheic dermatitis, contact dermatitis, atopic dermatitis, or psoriasis. Application was completed three times daily for 21 days. Assessments of erythema, edema, transudation, lichenification, scaling, pruritus and/or pain were completed at baseline and Days 4, 7, 14, and 21. Overall therapeutic response was assessed at all follow-up visits. Forty-nine subjects were entered, ranging in age from 1 month to 88 years of age. Thirty-eight subjects completed the studies, with 11 subjects lost to follow-up after the first visit. Individuals between the ages of 13 and 19 years were pre-emptively excluded to avoid potential application of a corticosteroid to acne-affected or acne-prone skin.
Results: Treatment with clocortolone pivalate 0.1% cream resulted in decreases in erythema, edema, transudation, lichenification, scaling, and pruritus/pain in 76% of treated study subjects. The overall therapeutic response in approximately two-thirds of the subjects (68%) was rated as good to excellent. There were 7 adverse events noted over the course of the study that were judged to be related to treatment, all of which were cutaneous and localized to the site of application (acneiform eruptions, burning, and folliculitis).
Conclusion: Clocortolone pivalate 0.1% cream was effective in relieving the signs and symptoms of corticosteroid-responsive inflammatory dermatoses involving facial skin, including seborrheic dermatitis, contact dermatitis, atopic dermatitis, and psoriasis. Overall, the safety profile was favorable and devoid of any treatment-related serious adverse events.
J Drugs Dermatol. 2012;11(10):1194-1198.
Faris Azzouni MD,a Nathalie Zeitouni MD PhD,b and James Mohler MDa| |
J Drugs Dermatol. 2013;12(2):e30-e35.
James Leyden MDa, Mitchell Wortzman PhDb, Edward K. Baldwin PhDc| |
Background: Newer agents and formulations seek to improve the tolerability of topical retinoid therapy. Recently, a gel containing crystalline clindamycin 1.2% and tretinoin 0.025% (CLIN/RA) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of treating mild-to-moderate acne.
Objective: This single-center, randomized, evaluator-blind phase 1 study compared the tolerability of CLIN/RA to 0.1% tretinoin gel or 0.1% adapalene gel.
Results: Forty-five patients applied CLIN/RA once daily to one side of their face every day for 21 days. Patients were randomized to either tretinoin 0.1% (n=23) or adapalene 0.1% (n=22) on the contralateral side. A clinical evaluator assessed degree of erythema and scaling; patients provided subjective evaluations of burning, stinging, and itching.
Conclusion: CLIN/RA was significantly better tolerated than was 0.1% tretinoin gel, as evidenced by significantly reduced erythema (P<0.04), scaling (P<0.03), itching (P<0.02), burning (P<0.03) and stinging (P<0.04). A trend for greater erythema, scaling, and subjective discomfort for 0.1% adapalene gel compared to CLIN/RA was also evident.
Julia G. Hobson MD, Michael J. Cunningham MD, Kendra Lesiak MD MEd, Elizabeth B. Lester MD, Andrew R. Tegeder MD MS, Elizabeth Zeeck MD, Jeremy M. Hugh MD, and Julie H. Lin MD| |
BACKGROUND: Isotretinoin is an effective treatment for nodulocystic acne. Outside of required pregnancy testing, laboratory monitoring suggested by the manufacturers is vague. Dermatologists, therefore, monitor a variety of tests with variable frequency. Despite intense monitoring, the majority of patients do not have gross laboratory abnormalities that warrant changes in management.
OBJECTIVE: To survey US dermatologists regarding laboratory monitoring practices while prescribing isotretinoin.
METHODS: An online survey sent via e-mail to members of the American Academy of Dermatology.
RESULTS: 12,396 surveys were sent with a response rate of ~19%. At baseline >60% of responders check a CBC, LFTs, and a lipid panel. 74% check a monthly lipid panel and LFTs, while 57% check a monthly CBC. 75% report stopping isotretinoin when AST or ALT values reach 3 times normal; 89% report stopping at 4 times normal. When triglycerides reach 4 times normal, 72% stop the medication.
CONCLUSIONS: There is no consensus on isotretinoin monitoring tests and frequency, though the majority of dermatologists surveyed monitor a lipid panel and LFTs.
J Drugs Dermatol. 2017;16(6):557-564.
Tolerability Comparison of Adapalene Gel, 0.3% versus Tazarotene Cream, 0.05% in Subjects with Healthy Skin
Jonathan S. Dosik MD, Lori A. Johnson PhD| |
Result: Tolerability results for adapalene 0.3% gel and tazarotene 0.05% cream were statistically similar throughout the study. Investigator-assessed overall tolerability was in favor of adapalene at days 19 and 22 (P=.043). A cosmetic acceptability survey also showed results were better for adapalene 0.3% gel.
Conclusion: Adapalene gel 0.3% is very well-tolerated with good cosmetic acceptability.
Diane S. Berson MD FAAD, Joel L. Cohen MD FAAD, Marta I. Rendon MD, Wendy E. Roberts MD,Isaac Starker MD FACS, Beatrice Wang MD FRCPC FAAD| |
Simon Nigen, MD, FRCPC; Sandra R. Knowles, BScPhm; and Neil H. Shear, MD, FRCPC| |
Dermatologists’ Attitudes, Prescription, and Counseling Patterns for Isotretinoin: A Questionnaire-based Study
Arielle R. Nagler MD1 and Seth J. Orlow MD PhD1| |
J Drugs Dermatol. 2015;14(2):184-189.
Comparison of the Cutaneous Thermal Signatures Over Twenty-Four Hours With a Picosecond Alexandrite Laser Using a Flat or Fractional Optic
Emil A.Tanghetti MDa and Danielle M.Tartar MD PhDb| |
Safe and Efficacious Use of Intralesional Steroids for the Treatment of Focally Resistant Mycosis Fungoides
Deede Y. Liu MD,a* Tarek Shaath BA,b* Anand N. Rajpara MD,a Cody Hanson BS,c
Garth Fraga MD,d Ryan Fischer MD,a and Daniel J. Aires MDa
J Drugs Dermatol. 2015;14(5):466-470.
Pilot Evaluation of a Novel Topical Formulation Containing High Level, Cholesterol-Dominant, Physiological Lipids for Specific Targeting of Skin Barrier Deficits in Aging Skin
Hema Sundaram MD,a Ana Du BS,b Margarita Yatskayer MS,b Stephen Lynch PhD,b Yevgeniy Krol,c and Christian Oresajo PhDb| |
Macrene R. Alexiades-Armenakas MD PhD,a,b Jeffrey S. Dover MD,a-c and Kenneth A. Arndt MDc-e| |
J Drugs Dermatol. 2012;11(11):1274-1287.
Treatment of Facial Atrophic Scars With Esthélis,a Hyaluronic Acid Filler With PolydenseCohesive Matrix (CPM)
Ariel Hasson MD and William A. Romero MD| |
Treatment of Hidradenitis Suppurativa by Photodynamic Therapy With Aminolevulinic Acid: Preliminary Results
Eric S. Schweiger MD,a Christy C. Riddle MD,b Daniel J. Aires MDb| |
Background: The current standard of care for hidradenitis suppurativa (HS) includes antibiotics (oral/topical), retinoids (oral/topical)
and intralesional steroids and is unsatisfactory. Photodynamic therapy (PDT) with 20% 5-aminolevulinic acid (ALA) has been used
"off label" to treat acne vulgaris and may hold promise as a therapy for HS. This open-label, non-blinded study investigated the efficacy
and safety of ALA PDT for the treatment of HS using two blue light sources and intense pulsed light (IPL) for photoactivation.
Methods: Twelve subjects with active HS enrolled to undergo ALA PDT once weekly for four weeks with follow-up visits 4, 8, and 12 or more weeks later. Nine subjects completed the study through the week 8 follow-up visit. Lesions were counted at each treatment visit at week 4, week 8 and at the final week.
Results: Mean lesion counts were 11.25 at baseline, 6.5 at 4 weeks (50.8% reduction), and 7.5 at 8 weeks (29.9% reduction). Mean Global Severity Scores were 2.2 at baseline, 1.5 at 4 weeks, and 1.8 at 8 weeks. Mean DLQI scores were 17.3 at baseline, 13.1 at 4 weeks (27.2% improvement), 14.00 at 8 weeks (19.3% improvement) and 14.0 (19.3% improvement) at the final week (16-62 weeks). Three subjects (25%) had complete clearance and no active lesions 4 weeks after the final treatment. Treatments were more tolerable for subjects treated with blue light than with IPL.
Conclusion: ALA PDT may be a safe and effective treatment of hidradenitis suppurativa.
J Drugs Dermatol. 2011;10(4):381-386.
Robert H. Gotkin MD, Deborah S. Sarnoff MD, Giovanni Cannarozzo MD, Neil S. Sadick MD, Macrene Alexiades-Armenakas MD PhD| |
A series of 32 consecutive patients underwent a single laser resurfacing procedure with the a new microablative CO 2 laser. All patients were followed for a minimum of 6 months and were asked to complete patient satisfaction questionnaires; a 6 month post- operative photographic evaluation by an independent physician, not involved in the treatment, was also performed. Both sets of data were graded and reported on a quartile scale. Results demonstrated greater than 50% improvement in almost all patients with those undergoing treatment for wrinkles, epidermal pigment or solar elastosis deriving the greatest change for the better (>75%).
The Effect of Combined Calcipotriol and Betamethasone Dipropionate Ointment in the Treatment of Vitiligo: An Open, Uncontrolled Trial
Objective: To evaluate the efficacy and safety of calcipotriol 0.005%/betamethasone dipropionate 0.05% ointment in the treatment of vitiligo.
Methods: Thirty-one patients with vitiligo were enrolled in our study. The mean age of the patients was 32.6±11 years (range 18-56 years) and the mean duration of vitiligo was 3.7±5.8 years (range 0.07-30 years). Patients were treated with topical calcipotriol 0.005%/betamethasone dipropionate 0.05% ointment twice a day for at least 12 weeks, and the degree of repigmentation was analyzed using digital photography at baseline and at weeks 4, 8, and 12. The response was evaluated as excellent (76%-100%), moderate (51%-75%), mild (26%-50%), minimal (1%-25%), or no response. Possible adverse effects during the treatment period were also noted.
Results: Three patients (9.7%) had an excellent response, six patients (19.4%) had a moderate response, eight patients (25.8%) had a mild response, seven patients (22.6%) had a minimal response, and seven patients (22.6%) had no response. Patients at a progressive phase responded better to this ointment than patients at a stable phase (P=.005). The correlations between response rate and the duration of the disease were not significant (P=.791). Four adverse events related to the ointment were reported (pruritus, n=2; acne, n=2).
Conclusion: Calcipotriene 0.005%/betamethasone dipropionate 0.05% ointment is effective and well tolerated in the treatment of patients with vitiligo.
J Drugs Dermatol. 2012;11(10):e52-e54.
Vitamin A and Its Derivatives in Experimental Photocarcinogenesis: Preventive Effects and Relevance to Humans
Stanley S. Shapiro PhD,a Miri Seiberg PhD,b and Curtis A. Cole PhDc| |
J Drugs Dermatol. 2013;12(4):458-463.
Results of a Phase III, Double-Blind, Randomized, Parallel-Group, Non-Inferiority Study Evaluating the Safety and Efficacy of Isotretinoin-Lidose in Patients With Severe Recalcitrant Nodular Acne
Guy F. Webster MD PhD,a James J. Leyden MD,b and Jason A. Gross PharmDc| |
OBJECTIVE: Evaluate the safety profiles of isotretinoin-Lidose and food-dependent generic isotretinoin in the largest clinical study with isotretinoin—925 randomized patients from 49 study sites. Determine if the efficacy of this new formulation is noninferior to an existing isotretinoin.
METHODS: Multicenter, double-blind, randomized, parallel-group, noninferiority trial. Study medication was taken with meals twice daily for 20 weeks. Patients were followed for 4 weeks after the last dose. Safety evaluations included recordings of adverse events, assessments for depression, anxiety, emergent psychotic symptoms, and suicidal ideation/behavior, as well as DEXA and X-ray evaluations and changes in bone age. Two co-primary efficacy outcomes were measured to assess noninferiority: a) change in total nodular facial and truncal lesion count at from baseline to week 20 and b) percentage of patients who experienced at least 90% reduction in nodular facial and truncal lesion count from baseline to week 20.
LIMITATIONS: Although isotretinoin-Lidose can be taken without meals, it was given with food because the absorption of both formulations in the study had to be similar to detect noninferiority.
RESULTS: The safety profile of the 2 formulations was comparable. Criteria for noninferiority for both co-primary efficacy outcomes were met based on predetermined margins.
CONCLUSION: Safety and efficacy of isotretinoin-Lidose is similar and noninferior to food-dependent generic isotretinoin, respectively.
J Drugs Dermatol. 2014;13(6):665-670.
Richard A. Krathen MD, Cindy N. Berthelot MD, Sylvia Hsu MD| |
Mira Stotland MD, Anne M. Chapas MD, Lori Brightman MD, Sean Sukal MD, Elizabeth Hale MD, Julie Karen MD, Leonard Bernstein MD, Roy G. Geronemus MD| |
Objective: To determine the safety and efficacy of fractional photothermolysis treatment on striae alba and striae rubra.
Methods: Twenty female patients with striae rubra or striae alba on their abdomen, thighs, or buttocks were enrolled in the study. Lesions were randomized to receive treatment, with site-matched normal control areas. Patients received a total of 6 treatments using a 1550-nm, erbium-doped fiber laser with 2 to 3 weeks of elapsed time between treatments. Clinical response to treatment was assessed at each visit, and at 1-month, 2-month, and 3-month follow-up intervals by the patient and investigator. A comparison evaluation of 8 patients examining photographs of striae at baseline and at the 3-month follow-up evaluation which was assessed by 4 independent dermatologists using the quartile grading scale.
Results: The independent evaluators’ assessments of improvement from photographs of 8 randomly selected patients showed an overall improvement of 26% to 50% in 63% (5/8) of patients. A less than 25% improvement in dyschromia was noted in 50% (4/8) of patients. An improvement in texture of 26% to 50% was observed in 50% (4/8) of patients. The clinical responses were indepen- dent of age, gender, and skin phototype. The treatments were tolerated well by all patients with a majority of patients experiencing transient posttreatment erythema and edema.
Conclusion: Fractional photothermolysis can be effectively and safely used in the treatment of striae rubra and striae alba.
The Optimal Filler: Immediate and Long-Term Results With Emulsified Silicone(1,000 centistokes) With Cross-Linked Hyaluronic Acid
Methods and Materials: A simple, permanent method of tissue augmentation is described. U.S. Food and Drug Administration- approved liquid silicone (Silikon®) is emulsified with cross-linked hyaluronic acid through a Luer-Lok to Luer-Lok connector between two 3-cc syringes. This stable emulsion is injected through a 27G needle or through a 25G or 27G microcannula into the middermis, subcutaneous tissue, or periosteum.
Results: The results of 95 cases are described. The emulsion is most beneficial for distensible acne valleys, nasolabial folds, glabellar frown lines, augmentation of the vermilion border of the lips, and projection of the nose, cheekbones, and chin. Exterior nasal deviations and soft tissue defects are also improved. Complications are minimal and include temporary bruising, erythema, and mild edema. Any temporary small nodules are easily leveled with massage. Occasionally, it takes a repeat session at 1 month to completely elevate depressions. The resulting elevations remain stable during the 2-year follow-up period. No silicone granulomas have developed.
Conclusions: This methodology has replaced many indications for temporary, semipermanent, or permanent fillers.
J Drugs Dermatol. 2012;11(11):1336-1341.
A Prospective Split-Face Study of the Picosecond Alexandrite Laser With Specialized Lens Array for Facial Photoaging in Chinese
Yiping Ge MD, Lifang Guo MD, Qiuju Wu MD, Mengli Zhang MD, Rong Zeng MD, and Tong Lin MD PhD| |
Modulation of Cytokine and Nitric Oxide Production by Keratinocytes, Epithelial Cells, and Mononuclear Phagocytes in a Co-Culture Model of Inflammatory Acne
Objective: This study was conducted to quantitatively assess the products secreted by human epithelial keratinocytes in the presence and absence of macrophages/monocytes.
Methods: Cells were exposed to UVB radiation (50 mJ to 200 mJ per cm2) or treated with bacterial lipopolysaccharide (LPS) as stimulator of inflammatory response. Nitric oxide (NO) was measured by modified Griess assay and TNF-α was measured by quantitative ELISA. For the co-culture system, SC monocytes were seeded in a 24-well Transwell tissue culture plate whereas irradiated keratinocytes were seeded in the individual baskets subsequently placed on top of the monocyte cultures, and samples of culture supernatants were collected at 1 to 6 days.
Results: When primary human epidermal keratinocytes (NHEK) were irradiated with UVB, a dose-dependent stimulation of TNF-α production was observed (33% to 200% increase). TNF-α production was not changed significantly in SC monocytes/NHEK co-culture. In contrast, when macrophages were irradiated with UVB, significant inhibition of NO production (40% suppression, P<0.001) was seen.
Conclusion: This improved model of cutaneous inflammation could use multiple cells to study their interactions and to offer convenience, reproducibility, and a closer approximation of in vivo conditions.
J Drugs Dermatol. 2012;11(7):834-836.
Adalimumab Treatment in Women With Moderate-to-Severe Hidradenitis Suppurativa from the Placebo-Controlled Portion of a Phase 2, Randomized, Double-Blind Study
Alice Gottlieb MD PhD,a Alan Menter MD,b April Armstrong MD,c Christopher Ocampo MD,d Yihua Gu MS,d and Henrique D. Teixeira PhDd| |
J Drugs Dermatol. 2016;15(10):1192-1196.