Search Results for "Infections ( Viral / Bacterial / Fungal )"
Joshua A. Zeichner MD| |
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2015;14(suppl 10):s35-s41.
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2015;14(suppl 10):s32-s34.
Kenneth Beer MD PA,a Michael S. Beer,a and Danielle Applebaum MS IVb| |
J Drugs Dermatol. 2013;12(6):694-697.
Vicky Kwan Wong, BA; Christine Della Croce, MA; Sara Schonfeld; Anthony M. Mastrangelo, PhD and Mark Lebwohl, MD| |
Jashin J. Wu MD,a Kathleen E. Gilbert MD,b Michael Batech DrPH,c Iviensan F. Manalo MD,d William J. Towner MD,c,e Rui André Saraiva Raposo PhD,f,g Douglas F. Nixon MD,f,g and Wilson Liao MDh| |
BACKGROUND: HIV-associated psoriasis is well-documented. Genetic, cellular, and cytokine profiles have been used as evidence to suggest psoriasis activates antiviral pathways. There has been a lack of epidemiologic evidence investigating whether psoriasis patients have lower HIV viral counts compared to non-psoriasis patients.
OBJECTIVE: Compare the viral load set point of HIV positive patients with and without psoriasis.
METHODS: A retrospective matched cohort study of HIV positive patients with and without psoriasis using the Kaiser Permanente Southern California Health Plan database.
RESULTS: We identified 101 HIV-positive psoriasis cases; 19 met inclusion criteria and were matched with 3-5 control patients; 94 total patients were analyzed. The mean age was 41.4 (12.07) years and 83% were male. Overall, the median log of the viral load of cases was slightly higher than controls (4.3 vs 4.2; P less than 0.01).
CONCLUSIONS: The serum viral load set point of patients with HIV and psoriasis was slightly higher than the viral load set point of HIV patients without psoriasis.
J Drugs Dermatol. 2017;16(4):372-377.
Benjamin Bashline DO,a Megan Morrison DO,a James Ramirez MD,b and Ann LaFond MDc,d| |
J Drugs Dermatol. 2014;13(8):976-978.
Ethan T. Routt MD,a Shelbi C. Jim On MD,a Joshua A. Zeichner MD,a and Leon H. Kircik MDb,c,d| |
J Drugs Dermatol. 2014;13(4):391-395.
X-linked Chronic Granulomatous Disease With Voriconazole-inducedPhotosensitivity/Photoaging Reaction
Stephanie Frisch MSIV, Sharone K. Askari MD, Stacy Russel Beaty MD, Nicole Burkemper MD| |
Trichophyton Tonsurans Associated Tinea Corporis Infection with the Development of Majocchi’s Granuloma in a Renal Transplant Patient
Vidya Rajpara MD, Stacy Frankel MD, Cindy Rogers MD, Keyvan Nouri MD| |
Optimizing Topical Antifungal Therapy for Superficial Cutaneous Fungal Infections: Focus on Topical Naftifine for Cutaneous Dermatophytosis
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
A variety of topical antifungal agents are available for the treatment of SCFIs, and they encompass a few major chemical classes: the polyenes (ie, nystatin), imidazoles (ie, ketoconazole, econazole, oxiconazole, etc), allylamines (ie, naftifine, terbinafine), benzylamines (ie, butenafine), and hydroxypyridones (ie, ciclopirox). The 2 major classes that represent the majority of available topical antifungal agents are the azoles and the allylamines. Overall, the allylamines are superior to the azoles in activity against dermatophytes, although both are clinically effective. The reverse is true against yeasts such as Candida spp and Malassezia spp, although topical allylamines have proven to be efficacious in some cases of tinea versicolor and cutaneous candidiasis.
Naftifine, a topical allylamine, is fungicidal in vitro against a wide spectrum of dermatophyte fungi and has been shown to be highly effective against a variety of cutaneous dermatophyte infections. Rapid onset of clinical activity and favorable data on sustained clearance of infection have been documented with naftifine. The more recent addition of naftifine 2% cream has expanded the armamentarium, with data supporting a clinically relevant therapeutic reservoir effect after completion of therapy.
J Drugs Dermatol. 2013;12(suppl 11):s165-s171.
Retapamulin: An Antibacterial With a Novel Mode of Action in an Age of Emerging Resistance to Staphylococcus aureus
Jeffrey M. Weinberg MD and Stephen K. Tyring MD PhD| |
Treatment of Biopsy and Culture Negative Mycobacterium Marinum: Diagnostic and Therapeutic Considerations
Patrick Tenbrick,a Michael Beer,b and Kenneth Beer MD PAa| |
J Drugs Dermatol. 2014;13(2):204-206.
Leon H. Kircik MD| |
Leflunomide: An Immune Modulating Drug That May Have a Role in Controlling Secondary Infections With Review of Its Mechanisms of Action
Kathleen J. Smith MDa and Marguerite Germain MDb| |
OBSERVATIONS: We present three patients with atopic dermatitis on azathioprine therapy who had multiple verrucae and in two molluscum contagiosum (MC) that were resistant to repeated conventional therapies. These patients were switched to LEF, and all the patients showed complete resolution of their verrucae and MC within 2 months of starting therapy. In addition, all three patients showed equivalent to better control of their atopic dermatitis with LEF.
CONCLUSIONS: LEF has previously been reported to be a useful immune modulator for the treatment of severe atopic dermatitis. The spectrum of anti-viral effects previously seen with leflunomide did appear beneficial in these patients in clearing verrucae and MC, which had been resistant to conventional therapies while the patients were on azathioprine.
J Drugs Dermatol. 2015;14(3):230-234.
Diagnostic and Therapeutic Considerations for Onychomycosis and Cutaneous Superficial Fungal Infections
New antifungal medicines on the market include topical drugs such as luliconazole, naftifine, efinaconazole, and tavaborole. This CME supplement translates a plethora of recent data on efficacy, ease of use, and safety data for each drug into dermatologists’ real world practices to help them optimize clinical outcomes in the treatment of onychomycosis, tinea corporis, tinea cruris, and tinea pedis.
However, proper drug selection is only one part of achieving a successful clinical outcome. This supplement also explains the patient education needed to avoid primary treatment failure, recurrence, or spread to other body parts or close contacts.
Cutaneous Non-Tuberculous Mycobacterial Infections in the Outpatient Setting: Presentation of a Case, Review of the Literature, and Therapeutic Considerations
Tara Spicer and Kenneth Beer MD| |
J Drugs Dermatol. 2014;13(12):1495-1497.
Martha P. Arroyo, MD, PhD; Patricia Heller, MD and Miriam Keltz Pomeranz, MD| |
Drug reactions are an uncommon and unpredictable complication of medical therapy. Cutaneous drug reaction rates occur with a frequency of 1% to 8% and can be higher for certain classes of drugs1. They can range from mild morbilliform eruptions to more severe forms such as drug-hypersensitivity syndrome, toxic epidermal necrolysis or anaphylaxis. Acute generalized exanthematous pustulosis (AGEP) is a rare presentation of a drug reaction and can be difficult to distinguish from other pustular dermatoses. Herein we review a case of AGEP and include a discussion of salient clinical and histological features of AGEP.
Leon H. Kircik MD| |
J Drugs Dermatol. 2016;15(Suppl 2):s44-48.
Ted Rosen MD| |
J Drugs Dermatol. 2016;15(Suppl 2):s49-55.
Prevalence of Community-acquiredMethicillin-resistant Staphylococcus Aureus in aPrivate Dermatology Office
Aaron M. Bruce DO, James M. Spencer MD MS| |
Objective: Investigators sought to examine the period prevalence of CA-MRSA infections involving skin and soft tissue in a suburban private practice dermatology setting.
Methods: Chart reviews of 170 patients who had bacterial cultures taken from January 2007 to November 2007 were performed, with an analysis of sex, age, immune status, species of growth, type of lesion, and culture site.
Results: The mean age of the study population was 54.0 years (SD 21.8) and 51.1% were male. Of the 170 cultures taken, 135 (79%) grew 1 or more bacteria and MRSA positive cultures were found in 28 (21%) of 135 cultures.
Limitations: Only 1 geographic location was represented.
Conclusion: The rising rates of CA-MRSA skin and soft tissue infections should be evaluated with consideration of the unique populations that the majority of reports represent. There is little doubt that the prevalence of skin infections caused by CA-MRSA have increased dramatically and will likely continue to do so in the future. However, the authors caution the empiric prescribing of antibiotics presently known to be effective against CA-MRSA and advocate the culturing of all infectious lesions upon presentation and reserve these antibiotics (tetracyclines, trimethoprim-sulfamethoxazole [TMP-SMX], clindamycin, rifampin) for the treatment of high-risk patients and patients with culture proven CA-MRSA infections.
Angelo Landriscina BA,a Tagai Musaev BA,a Bijal Amin MD,b and Adam J. Friedman MDa,c| |
J Drugs Dermatol. 2014;13(12):1491-1493.
Kenneth Beer MD and Jill Waibel MD| |
F. Emily Bell, MD and Melissa P. Daniles, MCS| |
Novel Antibacterial Activity of Monolaurin Compared with Conventional Antibiotics against Organisms from Skin Infections: An in Vitro Study
Beatriz G. Carpo MD, Vermén M. Verallo-Rowell MD, Jon Kabara MS PhD| |
Bengu Nisa Akay MD, Ahu Arslan MD, Saban Cekirge BS, Gul Erkin MD, Rana Anadolu-Brasie MD| |
Eric S. Schweiger, MD; Noah S. Scheinfeld, MD; Hillarie R. Tishler, BA and Jeffrey M. Wienberg, MD| |
Ted Rosen MD| |
J Drugs Dermatol. 2016;15(6):775-777.
David O. Schairer MD,a Jason S. Chouake MD,a Allison J. Kutner,a Joy Makdisi,a
Josh D. NosanchukMD,b,c and Adam J. Friedman MDd,e
J Drugs Dermatol. 2013;12(11):1272-1277.
Ralph Fiore II DO, Sarah M. Coffman DO MSc, and Richard Miller DO| |
J Drugs Dermatol. 2013;12(3):353-357.
Heat-Shock Proteins as Drugs: Potential Applications in Cancer, Infections, and Autoimmune and Atopic Diseases
Aton M. Holzer MD, Frank Martiniuk PhD, William R. Levis MD| |
Theodore Rosen MD| |
J Drugs Dermatol. 2015;14(suppl 10):s48-s54.
Antifungal Activity, Experimental Infections and Nail Permeation of an InnovativeCiclopirox Nail Lacquer Based on a Water-soluble Biopolymer
Giuseppe Togni PhD and Federico Mailland MD| |
Jesper F. Nygart MD,a Victoria A. Nygart MSoc,a Marie Borggren PhD,b Michael Tvede MDc| |
METHOD: This retrospective study of outcomes following polyacrylamide hydrogel injections includes 657 subjects from one centre, which had facial injections from 2001 and 2011. Until 2007 prophylactic antibiotics were not given prior to treatment, but in September 2007 a single oral dose of azithromycin (Zitromax) and moxifloxacin (Avelox) was introduced as prophylactic antibiotics. A total of 496 subjects were injected before 2007 without antibiotic prophylactic treatment, and 161 subjects received these two antibiotics prior to treatment from September 2007.
RESULTS: The prophylactic antibiotics (azithromycin and moxifloxacin) significantly reduced the incidence of clinical signs of inflammation/infections from 7 to 2% (P=0.03).
CONCLUSION: Even though the incidence of inflammation/infections following injection of polyacrylamide hydrogel is relatively low, it may be reduced further by using prophylactic antibiotic treatment. Based on our experience, we recommend prophylactic antibiotics to patients who have facial augmentation with polyacrylamide hydrogel in order to avoid infection and risk of biofilm formation due to contamination during injection with naturally occurring micro flora from skin and lips.
J Drugs Dermatol. 2014;13(5):571-573.
Simon Nigen, MD, FRCPC; Sandra R. Knowles, BScPhm; and Neil H. Shear, MD, FRCPC| |
Background: Scalp hyperkeratosis and/or alopecia are common pediatric dermatologic findings. In Caucasian children, scalp hyperkeratosis
of childhood is most often associated with atopic and seborrheic dermatides. Recent data is lacking on the clinical meaning of scalp hyperkeratosis and alopecia in children of color.
Objective: To determine diagnosis associated with scalp hyperkeratosis and/or alopecia in a predominately Black and Hispanic pediatric patient population.
Methods: A retrospective chart review was conducted for all children (0-17 years of age) seen at our institution who had a scalp fungal culture for the evaluation of scalp hyperkeratosis and/or alopecia from January 2007 to September 2009. Fungal culture was performed using cotton swab technique, plating onto Sabouraud's and Mycosel media. Demographic features, fungal culture results, clinical symptoms, physical findings and final diagnosis were reviewed.
Results: 164 children were identified who were eligible for inclusion in the study, 75 of whom were Black and 56 Hispanic/Latino. Scalp hyperkeratosis was noted in 106 patients and alopecia was noted in 71 subjects. Tinea capitis was the final diagnosis in 50 out of 80 children who had hyperkeratosis without alopecia (60%), 16 of 43 children with alopecia alone (37.2%) and 23 of 28 children with both hyperkeratosis and alopecia (82.1%, P=0.0007). The odds ratio of tinea capitis in the presence of hyperkeratosis with alopecia was 7.49 with a 95 percent confidence limit of 2.19-25.70.
Conclusion: Scalp hyperkeratosis, especially when accompanied by alopecia, is usually associated with tinea capitis in Black and Hispanic children. Fungal culture and empirical anti-fungal therapy are warranted in children of color with scalp hyperkeratosis.
J Drugs Dermatol. 2011;10(5):511-516.
Wendy Cantrell DNP, Theresa Canavan MD, and Boni Elewski MD| |
J Drugs Dermatol. 2015;14(5):524-526.
Efficacy and Safety of Naftifine HCl Cream 2% in the Treatment of Pediatric Subjects With Tinea Corporis
Michael Gold MD,a Sunil Dhawan MD,b Amit Verma DrPH MPH,c Michael Kuligowski MD PhD MBA,c and David Dobrowskic| |
OBJECTIVE: To evaluate the efficacy and safety of two-weeks once daily application of naftifine cream 2% in the treatment of tinea corporis among pediatric subjects.
METHODS: At baseline, 231 subjects were randomly assigned 1:1 to naftifine cream 2% (n=116) and vehicle (n=115). Treatment effect consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline, week 2 (end of treatment) and week 3. Efficacy was analyzed in 181 subjects (n=88, naftifine; n=93, vehicle) with a positive baseline dermatophyte culture and KOH for whom week 3 assessments were available. Safety was evaluated by adverse events (AE) and laboratory values in 231 subjects (n=116, naftifine; n=115, vehicle).
RESULTS: Children with tinea corporis treated with naftifine cream 2% demonstrated significantly greater improvements from baseline over vehicle for mycological cure (P<0.0001) and treatment effectiveness (P=0.003) as early as 2 weeks (end of treatment). Response rates continued to increase post-treatment and were the highest 1-week after completion of the therapy (P=0.003 for complete cure; and P<0.001 for mycological cure and treatment effectiveness). Treatment related adverse events were minimal.
CONCLUSIONS: Treatment with naftifine cream 2% applied once daily for two weeks was well-tolerated and was effective in treating tinea corporis in children. Further improvement was observed 1-week after treatment completion for all key outcome measures (complete cure, mycological cure, treatment effectiveness, clinical cure, and clinical success) and clinical signs and symptoms (erythema, induration, and pruritus).
J Drugs Dermatol. 2016;15(6):743-748.
Boni E. Elewski MD,a Phoebe Rich MD,b Antonella Tosti MD,c David M. Pariser MD,d Richard Scher MD,e Ralph C. Daniel MD,f and Aditya K. Gupta MDg| |
J Drugs Dermatol. 2013;12(7 suppl 2):s96-s103
Tatiana S. Sousa MD, Ryan J. Matherne MD, Michael G. Wilkerson MD| |
Non-Tuberculous Mycobacterial Infections Following Cosmetic Laser Procedures: A Case Report and Review of the Literature
Jacqueline Goulart Berliner MD,a Bishr Aldabagh MD,a Thaddeus Mully MD,b
Siegrid S. Yu MD,a Brian S. Schwartz MD,c Timothy G. Berger MDa
J Drugs Dermatol. 2015;14(1):80-83.
Skin Microbiome in Patients With Psoriasis Before and After Balneotherapy at the Thermal Care Center of La Roche-Posay
Richard Martin MSc,a Jessica B. Henley PhD,b Patrick Sarrazin MD,c and Sophie Seité PhDd| |
METHODS: This open label study was conducted between July and September 2012. Microbial communities of patients with psoriasis vulgaris were characterized prior and post a 3-week selenium-rich water balneotherapy treatment at the thermal care center La Roche-Posay (La Roche-Posay, France). Balneotherapy consisted of high-pressure filiform showers, baths, facial, and body spray treatments as well as La Roche-Posay thermal spring water (LRP-TSW) consumption. Swabs were taken from affected and proximal unaffected skin and the 16S rRNA bacterial gene was used to analyze the composition of bacterial communities. Using the same 16S rRNA gene tool, we tried to describe the LRP-TSW bacterial landscape.
RESULTS: This study included 54 patients diagnosed with moderate to severe forms of psoriasis vulgaris. After eliminating individuals lacking paired samples from both visits, 29 individuals were analyzed for their microbiome profile. Shannon Diversity Index and global bacterial landscape indicate similar microbial communities on both unaffected and adjacent affected skin. PASI values decreased post-balneotherapy implying improvement of disease severity. No significant change in the Shannon Diversity Index was noticed at the end of the third week. The average taxonomic composition of skin microbial communities associated with unaffected and affected skin of psoriatic patients post-balneotherapy shows that treatment with LRP-TSW significantly increased the level of Xanthomonas genus and, to a lesser extent, Corynebacterium genus. The Xanthomonas genus belongs to the main Xanthomonadaceae family found in LRP-TSW and also on healthy skin.
CONCLUSIONS: In psoriatic patients, a poor bacterial biodiversity was noticed and the bacterial communities were similar on unaffected and affected adjacent skin. Family analysis identified, for the first time, Xanthomonadaceae belonging to Proteobacteria phylum and known to be keratolytic, associated with the clinical improvement observed after a 3-week balneotherapy treatment. This data supports the interest of selenium-rich thermal spring water in the treatment of psoriasis vulgaris.
J Drugs Dermatol. 2015;14(12):1400-1405.
Noah Scheinfeld MD| |
Lilla Landeck MD, Sonja Sabath,a Swen Malte John MD, Guenther Gediga PhD, Nanna Y. Schurer MD| |
Daniel Opel MA,a Afrodite Economidi MD,b Daphne Chan PhD,c Yasmine Wasfi MD PhD,cSameer Mistry BSc MB ChB MRCS,d Theognosia Vergou MD,b Christina Antoniou MD PhD,band Howard Sofen MDe
aLoyola University Chicago Stritch School of Medicine, Chicago, IL bPsoriasis Clinic, Department of Dermatology, University of Athens, A. Sygros Hospital, Athens, Greece cDepartment of Immunology, Janssen Research & Development, LLC, Spring House, PA dDepartment of Medical A7airs, Janssen-Cilag Ltd, Buckinghamshire, UK eDermatology Research Associates, Los Angeles, CA
Objective: To report the first known cases of acute HBV infection in 2 ustekinumab-treated patients with psoriasis from a phase 3 (PHOENIX 1) and a phase 4 (TRANSIT) study.
Results: Both ustekinumab-treated patients generated an immune response toward HBV and experienced typical courses of infection, without progression to chronic HBV infection.
Conclusion: Continued monitoring of liver-related adverse events in clinical trials, registries, and spontaneous reporting from the postmarketing setting will further contribute to understanding the role of ustekinumab in viral hepatitis.
J Drugs Dermatol. 2012;11(12):1498-1501.
Clinical Trial Safety and Mortality Analyses in Patients Receiving EtanerceptAcross Approved Indications
Alice B. Gottlieb MD PhD,a Kenneth Gordon MD,b Edward H. Giannini MSc DrPH,c Philip Mease MD,d Juan Li PhD,e Yun Chon PhD,e Judy Maddox DO,e Haoling H. Weng MD MHS,e Joseph Wajdula PhD,f Shao-Lee Lin MD PhD,e Scott W. Baumgartner MDe| |
Patients and Methods: Forty-nine U.S. and non-U.S. trials of etanercept, involving up to 13,977 patients for approved indications, with final trial reports as of May 2006, were selected from the Amgen Inc. clinical trials database. Exposure-adjusted rates of serious infections, opportunistic infections, malignancies and deaths were reported by trial, indication and dosage.
Results: Rates of serious infections were generally similar between etanercept and controls. Overall rates of opportunistic infections and tuberculosis were low. The standardized incidence ratio (SIR) (95% CI) for malignancy was 1.00 (0.83–1.19) for all etanercept patients across all indications. The SIR for lymphoma for patients with rheumatoid arthritis was 3.45 (1.83-5.89); all other indications reported SIRs similar to those observed in the general population. The SIRs for cutaneous squamous cell carcinoma in patients with psoriasis relative to the general population with high or low sun exposure were 2.09 (1.27-3.22) and 4.96 (3.03-7.66), respectively. SIRs were less than 1.0 for all other indications regardless of sun exposure. Rates of melanoma and basal cell carcinoma were not significantly different from those in the general population. There was no increase in mortality associated with etanercept use relative to control populations.
Conclusion: These data support the overall tolerability of etanercept across approved indications.
J Drugs Dermatol. 2011;10(3):289-300.
Ralph C. Daniel MD| |
J Drugs Dermatol. 2013;12(11):1263-1266.
News, Views, and Reviews. Less May Be More for MRSA: The Latest on Antibiotics, the Utility of Packing an Abscess, and Decolonization Strategies
Kendra Gail Bergstrom MD FAAD| |
J Drugs Dermatol. 2014;13(1):89-92.
Jeffrey M. Weinberg MDa and Evelyn K. Koestenblatt MS MTa| |
The treatment of cutaneous fungal infections has been shown to be directly affected by the extent of patients' adherence to therapy regimens that are often cumbersome and last for several weeks. One useful alternative approach is once-daily dosing of topical antifungal agents rather than the traditional twice-daily regimen, an example of what has been called a “forgiving” regimen, designed to promote patient adherence. Sertaconazole, an imidazole antifungal agent, is known to be safe and effective when used twice daily in the treatment of tinea pedis. This report discusses a small (n=32) clinical trial designed to determine whether sertaconazole nitrate 2% cream, used once daily, is as effective as the traditional regimen. Results demonstrated that sertaconazole is as effective when used once daily for four weeks. Patients showed rapid improvement in pruritus as early as week 2, and at six weeks' follow up, all patients were free of erythema while 93.8 percent were free of pruritus; no relapses had occurred. These encouraging findings suggest that sertaconazole nitrate may be useful in a once-daily regimen and also may result in better patient adherence to therapy.
J Drugs Dermatol. 2011;10(10):1135-1140.
Emily M. Berger BA, Hassan I. Galadari MD, Alice B. Gottlieb MD PhD| |
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| |
Lindsey A. Brodell MD and Milan Anadkat MD| |
Prospective Efficacy and Safety Evaluation of Laser Treatments With Real-Time Temperature Feedback for Fungal Onychomycosis
Jill Waibel MD, Adam Jared Wulkan MD, and Ashley Rudnick| |
METHODS: Twenty-one patients with PAS or culture proven fungal onychomycosis were prospectively treated with laser until target temperature of 46 - 48 degrees Celsius was achieved using real-time infrared temperature feedback. The laser and light therapies used were 1319nm, 1064nm and BroadBand Light. Exclusion criteria included mixed infection and no other prior therapeutic interventions. Subjects received four treatment sessions one week apart. Assessments included PAS & cultures at one, three and six months post treatment. Patients also were asked a pain score from 1-10 during treatment.
RESULTS: Patients tolerated the procedures well with high satisfaction. Average treatment time was 10 minutes. No adverse events were noted. Patients reported mild-moderate transient discomfort during treatment. Six-month culture results revealed 20/21 negative for fungal organisms.
CONCLUSION: Laser therapy offers a safe and effective new option for onychomycosis. This may be the optimal therapy for a large market that needs alternative or adjunct to current therapies. Laser is quick, painless therapy that does not require any oral medications or blood test for monitoring. Additional larger scientific studies are needed to confirm our pilot study results.
J Drugs Dermatol. 2013;12(11):1237-1242.
Progressive Macular Hypomelanosis Arising in a Young African American Woman inAssociation With Pregnancy and a Toxic Nodular Goiter
Emily P. Tierney MD and Iltefat Hamzavi MD| |
Emily P. Tierney MD,a David J. Kouba MD PhD,b C. William Hanke MD MPHc| |
Objective: To review the literature on the safety of tumescent liposuction, liposuction under general anesthesia and laser-assisted liposuction.
Results: Aggregate safety data on liposuction under tumescent anesthesia reveals over 100,000 body areas treated with liposuction. There were no serious complications of death, emboli, hypovolemic shock, perforation of thorax or peritoneum, thrombophlebitis, seizures, or toxic reactions to drugs. In contrast, in the plastic surgery literature, liposuction under general anesthesia was associated with complications of deep venous thrombosis or pulmonary embolus, abdominal or other organ perforation, infection, and bleeding. Most recently, survey data in the European literature analyzed data showed 72 cases of severe complications from liposuction, including 23 deaths in a 5-year period from 1998 to 2002. The most frequent complications were bacterial infections such as necrotizing fasciitis, gas gangrene, and different forms of sepsis. Further causes of lethal outcome were hemorrhages, perforation of abdominal viscera, and pulmonary embolism.
Conclusion: Tumescent local anesthesia utilizing lidocaine with epinephrine allows the removal of large volumes of fat with minimal associated blood loss and postoperative morbidity.
J Drugs Dermatol. 2011;10(12):1363-1369.
Hilary Baldwin MD| |
Viral M. Patel BS, Robert A. Schwartz MD MPH DSc (Hon), and W. Clark Lambert MD PhD| |
J Drugs Dermatol. 2016;15(7):830-834.
An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftifine HCl Gel 2% in Pediatric Subjects With Tinea Pedis
Amit Verma DrPH MPH, Babajide Olayinka MSc, Alan B. Fleischer Jr. MD| |
OBJECTIVE: To assess trends in efficacy, tolerability, safety, and to quantify the pharmacokinetics (PK) of topical naftifine hydrochloride gel 2% in pediatric subjects with tinea pedis.
METHODS: Twenty-eight subjects (22 pediatric and 6 adult controls) were enrolled and treated in the study. Approximately 2 grams of naftifine hydrochloride gel 2% was applied to each foot (4 grams total) for subjects with tinea pedis. Pharmacokinetic blood and urine samples were collected at various time points throughout the study. Efficacy was assessed based on potassium hydroxide, dermatophyte culture, and signs and symptom results at days 7, 14, and 28. Adverse event information was collected routinely.
RESULTS: The rate and extent of systemic exposure among the pediatric and adult control subjects was low. Adverse events were minimal and were not related to treatment. Positive results were observed as early as day 7; however the proportion of subjects achieving success generally increased over time through day 28 in both treatment groups.
CONCLUSIONS: Naftifine hydrochloride gel 2% was found to be well tolerated and safe. Trends in clinical benefit were observed throughout the treatment period; however, continued improvement in efficacy rates were observed during the post-treatment period.
J Drugs Dermatol. 2015;14(7):686-691.
Boni E. Elewski MD,a Aditya K. Gupta MD PhD FRCPC,b Ted Rosen MD,c Bryan D. Caldwell DPM,d David M. Pariser MD,e Leon H. Kircik MD,f Neal Bhatia MD,g and Antonella Tosti MDh| |
METHODS: We reviewed definitions of onychomycosis cure to develop a less stringent and more practical approach to assess improvement and treatment success.
RESULTS: Complete cure (totally clear nail and mycologic cure) remains an important regulatory standard. Mycologic cure (negative fungal culture and negative potassium hydroxide) is the only consistently reported outcome in clinical trials, however the potential for discrepancies between microscopy and culture can be problematic. We propose a more practical approach to assessing improvement in infected nails that relies on both physician and patient input in a similar fashion to other skin diseases.
CONCLUSIONS: Treatment success should be based on both physician and patient assessment of improvement in the affected toenails and negative fungal culture.
J Drugs Dermatol. 2016;15(5):626-632.
Maj. J. Scott Henning DO and Bahar F. Firoz MD MPH| |
Methods: A cross-sectional study was performed for all dermatology visits presenting to the Combat Dermatology Clinic, Ibn Sina, Iraq, between January 15, 2008 and July 15, 2008.
Results: In the six-month period reviewed, 2,696 total patients were evaluated. The most prevalent diagnoses included eczematous dermatitis [17%, n=462] and benign neoplasms [14%, n=375]. Eight percent (n=205) of the total visits were for skin cancer. This included: basal cell carcinoma, squamous cell carcinoma both in-situ and invasive, mycosis fungoides and melanoma. Actinic keratosis comprised 5% of the total visits (n=129). Bacterial infections comprised 6% (n=158) of the total visits and 31 of these cases were community acquired methicillin resistant Staphylococcus aureus (MRSA).
Limitations: Cross-sectional study with referral bias.
Conclusion: This is the largest publication of the prevalence of skin disease in an exclusively dermatologic clinic in a combat setting. For the first time the presence of skin cancer is noted in a combat setting. The prevalence of MRSA is noted and was exclusively seen in U.S. soldiers. There was a statistically significant rise in the prevalence of eczematous dermatitides when compared with previous conflicts. Dermatologists can have a significant and strategic impact on deployed military medicine.
Atypical Presentation of Histoplasmosis in a Patient With Psoriasisand Psoriatic Arthritis on Infliximab Therapy
Qurat ul Ain Kamili MD and Alan Menter MD| |
Diagnosis of Herpes Simplex Virus-Induced Erythema Multiforme Confounded by Previous Infection With Mycoplasma Pneumonia
Barry Ladizinski MD,a Joi B Carter MD,b Kachiu C. Lee MD MPH,c Denise M. Aaron MDd| |
J Drugs Dermatol. 2013;12(6):707-709.
Stephen B. Tucker, MD; Asra Ali, MD and Brian L. Ransdell, BA| |
The Incidence of Recurrent Herpes Simplex and Herpes Zoster Infection during Treatment with Arsenic Trioxide
Keyvan Nouri MD, Carlos A. Ricotti Jr. MD, Navid Bouzari MD, Halland Chen BS, Eugene Ahn MD, Bach Ardalan MD| |
Review of Cyclosporine Immunosuppressive Safety Data in Dermatology Patients after two Decades of Use
Shahrad M. Behnam BS, Shahdad E. Behnam MD, John Y. Koo MD| |
Emerging Oral Immunomodulators for the Treatment of Psoriasis: A Review of Phase III Clinical Trials for Apremilast and Tofacitinib
Rachel McAndrew MD,a,b Ethan Levin MD,b and John Koo MDb| |
METHODS: We reviewed phase III randomized, placebo-controlled clinical trial results for apremilast and tofacitinib for efficacy and safety in psoriasis.
RESULTS: Psoriasis Area and Severity Index (PASI) 75 after 16 weeks for apremilast was between 28.8% and 33.1%. PASI 75 was 39.5% after 12 weeks on tofacitinib 5 mg, and 63.6% after 12 weeks on tofacitinib 10 mg. Common side effects for both drugs included nasopharyngitis and upper respiratory tract infections. Gastrointestinal disturbance was common for apremilast. Dyslipidemia and infections were more common with tofacitinib than placebo.
CONCLUSION: Both new oral medications, apremilast and tofacitinib, appear to be effective in treating psoriasis.
J Drugs Dermatol. 2015;14(8):786-792.
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.
Rhoda S. Narins, MD| |
Alice B. Gottlieb MD PhD, Wolf-Henning Boehncke MD, Mohamed Darif PhD| |
Georgia Schuller-Levis MD,a William Levis MD,b and Israel Dvoretzkyc| |
J Drugs Dermatol. 2014;13(10):1194-1196.
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.
Luliconazole Retention in Stratum Corneum and Prevention of Fungal Infection in a Guinea Pig Tinea Pedis Model
Hiroyasu Koga PhD,a Yasuko Nanjoh,a Tetsuo Toga PhD,a Radhakrishnan Pillai PhD,b William Jo PhD,b and Ryoji Tsuboi PhDc| |
METHODS: Luliconazole 1% cream or terbinafine 1% cream were topically applied once daily to hind limbs of guinea pigs for 14 days. Drug concentration in stratum corneum of plantar skin was measured by HPLC-UV on days 1, 3, 7, 10, and 14. Separately, creams were applied daily for 5 days to the hind limbs of guinea pigs and skin drug release determined. In addition, drug retention in the stratum corneum was assessed by infecting guinea pigs with Trichophyton mentagrophytes, 14 and 21 days after a single application of luliconazole or terbinafine creams.
RESULTS: Luliconazole stratum corneum concentrations were higher than those of terbinafine throughout the study. Concentrations of luliconazole and terbinafine were 71.6μg/g and 36.6μg/g, respectively, after a single application (P<.05), reaching steady state after 10 days. Cumulative release of luliconazole from the stratum corneum was 4.5 times greater than with terbinafine. Unlike terbinafine, no fungal invasion of the stratum corneum was seen 14 days post-treatment with luliconazole.
CONCLUSIONS: Drug concentrations of luliconazole in the stratum corneum and subsequent release are greater than those achieved with terbinafine and may contribute to clinical efficacy. Luliconazole may also provide greater protection against disease recurrence.
J Drugs Dermatol. 2016;15(1):104-108.
Microbiome of Affected and Unaffected Skin of Patients With Atopic Dermatitis Before and After Emollient Treatment
Gilberto E. Flores PhD,a Sophie Seité PhD,b Jessica B. Henley MS,c Richard Martin MS Ing,d
Hana Zelenkova MD,e Luc Aguilar PhD,f Noah Fierer PhDa,c
J Drugs Dermatol. 2014;13(11):1365-1372.
A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Luliconazole Cream 1% Once Daily for 7 Days in Patients Aged ≥ 12 Years With Tinea Cruris
Terry M. Jones MD,a Michael T. Jarratt MD,b Ines Mendez-Moguel MD,c Nelly Paz MD,d Steven K. Grekin DO,e
Christina Cognata Smith PharmD MBA,f and Mandeep Kaur MD MSf
OBJECTIVE: This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1% in patients with tinea cruris.
METHODS: 483 patients were enrolled and 256 male and female patients aged ≥12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1% (n=165) or vehicle (n=91) once daily for 7 days. Efficacy was evaluated at baseline and at days 7, 14, 21, and 28 based on mycology (potassium hydroxide, fungal culture) and clinical signs (erythema, scaling, pruritus). The primary outcome was complete clearance at day 28 (21 days posttreatment). Safety evaluations included adverse events and laboratory assessments.
RESULTS: Complete clearance was obtained in 21.2% (35/165) of patients treated with luliconazole cream 1% compared with 4.4% (4/91) treated with vehicle (P<0.001). The safety profile of luliconazole cream 1% was similar to vehicle.
LIMITATIONS: The study was conducted under controlled conditions in a relatively small population.
CONCLUSION: Luliconazole cream 1% applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris.
J Drugs Dermatol. 2014;13(1):32-38.
Efficacy and Safety of Naftifine HCl Gel 2% in the Treatment of Interdigital and Moccasin Type Tinea Pedis: Pooled Results from Two Multicenter, Randomized, Double-Blind, Vehicle-Controlled Trials
Linda F. Stein Gold MD,a Lawrence Charles Parish, MD,b,c Tracey Vlahovic DPM,d Leon Kircik MD,e Stefan
Plaum MD,f Alan B. Fleischer Jr MD,f Amit Verma DrPH,f Babajide Olayinka MSc,f
and Bhushan Hardas MDf on behalf of the NAFT-600 Study Group*
OBJECTIVE: To evaluate the efficacy and safety of two-weeks once daily application of naftifine gel 2% in the treatment of tinea pedis.
METHODS: At baseline, 1715 subjects were randomly assigned 2:1 to naftifine gel 2% (n=1144) and vehicle (n=571). Efficacy consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline and weeks 2, 4, and 6. Efficacy was analyzed in 1174 subjects (n=782, naftifine; n=392, vehicle) with a positive baseline dermatophyte culture and KOH for whom week 6 assessments were available. Safety was evaluated by adverse events (AE) and laboratory values in 1714 subjects (n=1143, naftifine; n=571, vehicle).
RESULTS: Subjects treated with naftifine gel 2% for interdigital-type tinea pedis demonstrated greater improvement from baseline for complete cure (P=0.001), mycological cure (P<0.0001), and treatment effectiveness (P<0.0001) as early as 2 weeks when compared to vehicle; however the highest response rates were seen 4-weeks post treatment (P<0.0001, for all endpoints). Statistically significant results for complete cure, mycological cure, and treatment effectiveness (P<0.0001, for all endpoints) were also seen at week 6 among subjects with moccasin-type tinea pedis. Treatment related adverse events were minimal.
CONCLUSIONS: Treatment with naftifine gel 2% applied once daily for two weeks is well-tolerated and is effective in treating both interdigital-type and moccasin-type tinea pedis. Continuous improvement is observed from the end of treatment to four-weeks after treatment cessation among key outcome measures (complete cure, mycological cure, and treatment effectiveness) as well as clinical signs and symptoms (erythema, scaling, and pruritus).
J Drugs Dermatol. 2013;12(8):911-918.
Photodynamic Therapy for Molluscum Contagiosum Infection in HIV-Coinfected Patients: Review of 6 Patients
Ali Moiin, MD| |
Use of Naftifine Hydrochloride 2% Cream and 39% Urea Cream in the Treatment of Tinea Pedis Complicated by Hyperkeratosis
Leon Kircik MDa,b,c and Neh Onumah MDd| |
J Drugs Dermatol. 2014;13(2):162-165.
Frank Martiniuk PhD, David S. Lee MD, Anthony Gaspari MD, Herman Yee MD PhD, Luis Chiriboga PhD, Maryann Huie PhD, Kam-Meng Tchou-Wong PhD, and William R. Levis MD| |
Perry Robins MD, Sherry Hsiung MD| |
William L. Fangman, MD; Caroline H. Rao, Md and Sarah A. Myers, MD| |
Dhaval Bhanusali MD, Marcelyn Coley MD, Jonathan I. Silverberg MD MPH PhD, Andrew Alexis MD MPH and Nanette B. Silverberg MD| |
Objective: To determine prevalent fungal species and response to standard antifungal therapy in inner-city children of color.
Methods: An IRB-approved chart review of demographic, clinical, diagnostic, and therapeutic data was conducted for children and young adults (0 to 18 years of age) who had scalp fungal culture performed for scalp hyperkeratosis and/or alopecia over a 2.5 year time-period. Supplemental parental phone interview was performed for missing data points.
Results: A total of 84 patients with final diagnosis of tinea capitis were identified—52% male, 60.6% African-American, 28.2% Hispanic, and 9.9% Caucasian. Complete resolution at 4 weeks was uncommon in all demographic groups (Hispanic: 11.7%, African-American: 41.3%). The Hispanic group and the youngest patients (aged less than 4 years) were less likely to respond to initial therapy, but the results were not significant. Of the 80 tinea capitis patients initially treated with griseofulvin, 41 out of 54 children (76%) had complete response to micronized suspension +/- crushed tablet (33% required shift to tablets from suspension) and 20 out of 26 (76.9%) cleared on crushed tablets alone. Of the 19 griseofulvin failures, 5 cleared on fluconazole suspension, 7 on terbinafine sprinkles, 3 on itraconazole therapy, and 4 were lost to follow-up. Of the 47 patients who could be evaluated long-term after a single course of oral griseofulvin at 6 weeks or greater, 38 had documented long-term mycological cure (80.8%) and 42 had long-term clinical cure (89%). Trichophyton tonsurans (n=40) was the most prevalent causative species identified on culture, followed by Alternaria species (n=10) and Microsporum canis (n=1).
Limitations: Retrospective chart review: patient population has a high rate of usage of over-the-counter antifungal creams and shampoos, affecting culture results.
Conclusions: Tinea capitis is still the most common cause of Trichophyton tonsurans in New York City. Response rates to griseofulvin are similar to rates seen in the 1970s, but require higher dosing and conversion to crushed tablets in partial responders. Usage of crushed ultramicronized griseofulvin, terbinafine sprinkles, itraconazole, and fluconazole are alternative regimens for those children whose tinea capitis does not clear on griseofulvin suspension.
J Drugs Dermatol. 2012;11(7):852-856.
Jessica El-Kehdy MD,a Eckart Haneke MD,b and Paula G. Karam MDc| |
J Drugs Dermatol. 2013;12(2):228-230.
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.
Efinaconazole 10% and Tavaborole 5% Penetrate Across Poly-ureaurethane 16%: Results of In Vitro Release Testing and Clinical Implications of Onychodystrophy in Onychomycosis
Chris G. Adigun MD,a Tracey C. Vlahovic DPM,b Michael B. McClellan MS,c Kailas D. Thakker PhD,c Ryan R. Klein PhD,c Tuan A. Elstrom BS,d and Daniel B. Ward Jr. MD FAADd| |
OBJECTIVE: The purpose of this work was to determine through in vitro release testing (IVRT) whether poly-ureaurethane 16% allows for penetration of efinaconazole 10% or tavaborole 5%. Results could spur subsequent clinical studies which would have implications for the addition of an antifungal based on fungal confirmation, after addresssing the underlying nail dystrophy primarily.
METHODS: A vertical diffusion cell system was used to evaluate the ability of efinaconazole 10% and tavaborole 5% to penetrate across poly-ureaurethane 16%. The diffusion cells had a 1.0 cm2 surface area and approximately 8 mL receptor volume. Poly-ureaurethane 16% was applied to a 0.45 μm nylon membrane and allowed to dry before use. Efinaconazole 10% or tavaborole 5% was then applied to the poly-ureaurethane 16% coated membrane, and samples were pulled from the receptor chamber at various times. Reverse phase chromatography was then used to assess the penetration of each active ingredient across the membrane.
RESULTS: The flux and permeability of efinaconazole or tavaborole across poly-ureaurethane 16% were determined from efinaconazole 10% or tavaborole 5%, respectively. The flux and permeability of efinaconazole were determined to be 503.9 +/- 31.9 μg/cm2/hr and 14.0 +/- 0.9 nm/sec. The flux and permeability of tavaborole were determined to be 755.5 +/- 290.4 μg/cm2/hr and 42.0 +/- 16.1 nm/sec.
CONCLUSION: In addition to the treatment of onychoschizia, onychorrhexis, and other signs of severe dessication of the nail plate, a barrier that regulates TOWL should be considered in the management onychomycosis to address barrier dysfunction and to promote stabilization of the damaged nail. Previously published flux values across the nail are reported to be 1.4 μg/cm2/day for efinaconazole and 204 μg/cm2/day for tavaborole. These values are substantially lower than the herein determined flux for both molecules across poly-ureaurethane 16%. A comparison of the data suggests that poly-ureaurethane 16%, if used prior to efinaconazole or tavaborole, would not limit the ability of either active ingredient to access the nail, and therefore, would be unlikely to reduce their antifungal effect. Onychodystrophy is inherent in, and often precedes onychomycosis, and consideration should be given for initiation of treatment in the same sequence: stabilizing and protecting the nail plate barrier primarily, and subsequently adding oral or topical antifungals after laboratory confirmation. Future clinical studies will be needed to determine combination efficacy for in vivo use.
J Drugs Dermatol. 2016;15(9):1116-1120.
Econazole Nitrate Foam 1% for the Treatment of Tinea Pedis: Results from Two Double-Blind, Vehicle-Controlled, Phase 3 Clinical Trials
Boni E. Elewski MDa and Tracey C. Vlahovic DPMb| |
OBJECTIVE: To evaluate econazole nitrate foam 1% versus foam vehicle for treatment of interdigital tinea pedis.
METHODS: Two randomized, double-blind, parallel-group, vehicle-controlled, multicenter studies enrolled males and females ≥12 years old with a clinical diagnosis of interdigital tinea pedis and baseline fungal culture positive for a dermatophyte. Subjects applied econazole nitrate foam 1% (n=246) or foam vehicle (n=249) once daily for 4 weeks. The primary endpoint was proportion of subjects achieving a complete cure (negative KOH, negative fungal culture, complete resolution of all signs and symptoms) at 2 weeks post-treatment (Day 43). Secondary endpoints included mycologic cure (negative KOH and negative culture) and effective treatment (mycologic cure + no or mild erythema and/or scaling and all other signs and symptoms absent).
RESULTS: The complete cure rate at Day 43 was 24.3% for econazole nitrate foam 1% vs 3.6% for foam vehicle. In addition, higher rates of mycologic cure (67.6% vs 16.9%) and effective treatment (48.6% vs 10.8%) were observed with econazole nitrate foam 1% versus the foam vehicle. There were few adverse events and only nasopharyngitis and headache were experienced by >1% of subjects. No serious adverse events were reported for econazole nitrate foam 1%.
CONCLUSIONS: Econazole nitrate foam 1% exhibited superiority over foam vehicle for the primary and secondary endpoints with a high mycologic cure rate for all pathogens evaluated. Econazole nitrate foam 1% was safe and well tolerated with a safety profile comparable with the foam vehicle. Econazole nitrate foam 1% presents a novel alternative for the management of tinea pedis.
J Drugs Dermatol. 2014;13(7):803-808.
An Update on the Long-Term Safety Experience of Ustekinumab: Results From the Psoriasis Clinical Development Program With up to Four Years of Follow-Up
Objective: To evaluate the safety of ustekinumab in patients with moderate to severe psoriasis treated for up to four years.
Methods: Safety data were pooled across four Phase II/III randomized controlled trials. Rates over time and cumulative rates of adverse events (AEs), AEs leading to treatment discontinuation, serious adverse events (SAEs), serious infections, malignancies, and major adverse cardiovascular events (MACE) (i.e., cardiovascular death, myocardial infarction [MI], or stroke as adjudicated by an independent panel of academic cardiologists) were evaluated. Observed rates of AEs of interest were compared with those expected in the general (malignancies, MI, and stroke) and psoriasis (serious infections, MI, and stroke) populations.
Results: Overall, 3,117 patients were followed for up to four years (6,791 patient-years). Rates of AEs, AEs leading to treatment discontinuation, and SAEs remained stable over time, whereas cumulative rates were generally comparable between patients who received 45 mg and 90 mg of ustekinumab. The rates of AEs of interest also remained stable over time, and cumulative rates per 100 patient-years were 0.80 and 1.32 (serious infections), 0.70 and 0.53 (nonmelanoma skin cancer), 0.63 and 0.61 (other malignancies), and 0.56 and 0.46 (MACE) in patients treated with 45 mg and 90 mg, respectively. Rates of AEs of interest were consistent with those in the general and psoriasis populations.
Conclusion: The safety profile of long-term ustekinumab treatment with up to four years of continuous use remains consistent with previous reports, with no evidence of cumulative toxicity.
J Drugs Dermatol. 2012;11(3):300-312
Onychomycosis is a fungal infection of the nail unit that is caused by a variety of fungi including dermatophytes, nondermatophyte molds, and Candida. Efinaconazole 10% solution is a new topical treatment for onychomycosis that has a broad spectrum of activity against dermatophyte, nondermatophyte, and numerous yeast species. In clinical trials of mild to moderate onychomycosis, mycologic and complete cure rates for efinaconazole are comparable to those seen with oral itraconazole. Efinaconazole may be an important primary medication for those patients for whom effective topical treatment would be ideal, and could also be used in combination with an oral agent, or with adjunct therapies such as lasers and debridement.
Michael Jude Welsch, MD| |
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| |
J Drugs Dermatol. 2011;10(12):1469-1471.
Caren Garber BA,a,b Malcolm Creighton-Smith BA,a,b Eric P Sorensen BS,a Nicole Dumont,a
Alice B. Gottlieb MD PhDa,b
METHODS: In this case series, data were collected on patients ≤ 18 years old with moderate-to-severe psoriasis treated with systemic medications (traditional systemic drugs or biologics) from 2008 through 2014. Efficacy was measured using the validated simple measure for assessing psoriasis activity (S-MAPA), and the product of the body surface area and Physician Global Assessment.
RESULTS: Twenty-seven patients aged 5 to 18 years were eligible, and 56 treatment courses were analyzed. Methotrexate (MTX) was the most frequently prescribed systemic (70%), followed by etanercept (59%). Clearance rates were highest on biologic medications (67% for etanercept and adalimumab, 33% for ustekinumab). Phototherapy, cyclosporine, and MTX were less effective in clearing psoriasis, although they were successful in improving S-MAPA ≥ 50% from baseline 100%, 67%, and 36% of the time, respectively. The most common adverse events were sunburn for patients on narrowband ultraviolet B phototherapy (14%), gastrointestinal intolerance and minor infections for patients on MTX (16% each), and minor infections for patients on etanercept (25%) and adalimumab (33%). The most common reasons for discontinuation were secondary failure (38% for etanercept, 33% for adalimumab) or lack of response (37% for MTX, 33% for cyclosporine).
CONCLUSION: Although phototherapy, MTX, and cyclosporine are effective for controlling resistant pediatric psoriasis, concerns about long-term safety or inconvenience have led people to consider biologics in their place. However, there is a lack of literature on the use of biologics in pediatric psoriasis. These cases attest to the safety and efficacy of etanercept, adalimumab, and ustekinumab in pediatric psoriasis, expanding the treatment repertoire and guiding dermatologists in better managing recalcitrant pediatric psoriasis.
J Drugs Dermatol. 2015;14(8):881-886.
Treating Onychomycoses of the Toenail: Clinical Efficacy of the Sub-Millisecond 1,064 nm Nd: YAG Laser Using a 5 mm Spot Diameter
Background: Onychomycosis is a relatively common fungal infection. Current treatments have limited applicability and low cure rates.
Recently introduced laser therapy has shown to be a safe and effective treatment for onychomycosis. In this study, we evaluate a submillisecond Nd:YAG 1,064 nm laser for treating onychomycoses of the tonail.
Methods: Thirteen subjects (9 female, 4 male) with 37 affected toenails received 1 to 3 treatments 4 and/or 8 weeks apart with a sub-millisecond 1,064 nm Nd:YAG laser. Diagnosis of onychomycosis was confirmed with microscopy. Average follow-up time was 16 weeks post-final treatment. Photos were taken and degree of turbidity was determined using a turbidity scale (ranging from "0 = clear nail" to "10 = completely turbid nail") at each visit. Improvement in turbidity was determined by comparison of turbidity scores at baseline and 16-week follow-up on average. Efficacy was assessed by an overall improvement scale (0 to 4), which combined improvement in turbidity scores and microscopic examination. Overall improvement was classified as "4 = complete clearance" if the turbidity score indicated "0 = clear nail" accompanied by a negative microscopic result. No microscopic examination was performed unless the turbidity score showed "0 = clear nail."
Results: Treatments were well tolerated by all subjects and there were no adverse events. Of the 37 toenails treated, 30 (81%) had "moderate" to "complete" clearance average of 16 weeks post-final treatment. Nineteen toenails (51%) were completely clear and all tested negative for fungal infection on direct microscopic analysis. Seven (19%) toenails had significant clearance and four (11%) had moderate clearance.
Conclusions: The preliminary results of this study show this treatment modality is safe and effective for the treatment of onychomycosis in the short term. Additional studies are needed to more fully assess the clinical and mycological benefits as well as optimize the treatment protocol and parameters.
J Drugs Dermatol. 2012;11(4):496-504.
Benzoyl Peroxide Development, Pharmacology, Formulation and Clinical Uses in Topical Fixed-combinations
Julie C. Harper MD| |
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.
Ann R. Tucker BA,a Ashley N. Emerson MD,a Julie P. Wyatt MD,b Robert T. Brodell MDc| |
Safety Observations in 12095 Patients With Psoriasis Enrolled in an International Registry (PSOLAR): Experience With Infliximab and Other Systemic and Biologic Therapies
Alice B. Gottlieb MD PhD,1 Robert E. Kalb MD,2 Richard G. Langley MD,3 Gerald G. Krueger MD,4
Elke M.G.J. de Jong MD PhD,5 Lynn Guenther MD,6 Kavitha Goyal MD,7 Steven Fakharzadeh MD PhD,7
Marc Chevrier MD PhD,7 Stephen Calabro MS,7 Wayne Langholff PhD,8 Alan Menter MD9
OBJECTIVE: To evaluate the incidence of adverse events of interest (AEIs), including all-cause mortality, major adverse cardiovascular events (MACE), malignancy (excluding nonmelanoma skin cancer), and serious infections (SI), in patients treated for psoriasis in clinical practice settings.
METHODS: PSOLAR is a large, ongoing, observational study of patients receiving, or eligible to receive, biologic or systemic therapy for psoriasis. Cumulative incidence rates of AEIs per 100 patient-years (PY) are reported across treatment cohorts: (1) infliximab, (2) ustekinumab, (3) other biologics (eg, adalimumab and etanercept), and (4) non-biologic agents. Significant predictors of each AEI were identified using Cox proportional hazards regression methodology.
RESULTS: PSOLAR is now fully enrolled at 12095 patients followed for 31818PY. The cumulative rate was 0.46/100PY for death, 0.36/100PY for MACE, 0.68/100PY for malignancy, and 1.50/100PY for SI. Increasing age was a significant predictor of all AEIs. A history of cardiovascular disease, malignancy, and significant infection was associated with a higher risk of developing MACE, malignancy, and SI, respectively. Exposure to infliximab (Hazard Ratio [HR]=3.101, P<0.001) and exposure to other biologics (HR=1.736, P<0.001) were significant predictors of SI. Use of immunomodulators (HR=1.954, P=0.005) was a significant predictor of MACE. Compared with non-biologic therapy, the use of biologic agents was not a significant predictor of death, MACE, or malignancy.
CONCLUSIONS: Based on PSOLAR data through 2013, no new safety concerns were observed with infliximab for all-cause mortality, MACE, or malignancy; the data suggest that infliximab was associated with serious infections.
J Drugs Dermatol. 2014;13(12):1441-1448.
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.
Robert Denison Griffith MD,a Mohammad-Ali Yazdani Abyaneh BS, Leyre Falto-Aizpurua MD, and Keyvan Nouri MD| |
OBJECTIVES: To review the use of PDL for the treatment of MC.
MATERIALS AND METHODS: A search of the National Library of Medicine’s PubMed Database and the SCOPUS Database was performed to find articles that detailed the treatment of MC with PDL.
RESULTS: Eight articles met criteria for inclusion in this review. These articles represented 161 patients with over 4200 MC lesions that were treated with PDL. Each article was reviewed and summarized in a table.
LIMITATIONS: The main limitation of this review is the small number of published studies, which reflects the importance of this review of the dermatology literature.
CONCLUSIONS: PDL offers a novel and effective treatment for MC. However, the articles reviewed herein suggest PDL is a safe, effective, quick and well-tolerated treatment for clearing MC lesions that does not cause scarring or permanent pigment change.
J Drugs Dermatol. 2014;13(11):1349-1352.
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.
Kenneth Beer MD PA and Hillary Oakley PA C| |
Combination of Essential Oil of Melaleuca alternifolia and Iodine in the Treatment of Molluscum Contagiosum in Children
Molluscum contagiosum is a common childhood viral skin condition and is increasingly found as a sexually transmitted disease in adults. Current treatment options are invasive, requiring tissue destruction and attendant discomfort. Fifty-three children (mean age 6.3+5.1 years) with the diagnosis of molluscum contagiosum were treated with twice daily topical application of either essential oil of Melaleuca alternifolia (TTO), a combination of TTO and organically bound iodine (TTO-I), or iodine alone. At the end of 30 days, 48 children were available for follow up. A greater than 90% reduction in the number of lesions was observed in 16 of 19 children treated with TTO-I, while 1 of 16 and 3 of 18 children met the same criteria for improvement in the iodine and TTO groups (P<0.01, ANOVA) respectively by intention-to-treat analysis. No child discontinued treatment due to adverse events. The combination of essential oil of M. alternifolia with organically bound iodine offers a safe therapeutic alternative in the treatment of childhood molluscum. Clinical Trial Registry ACTRN12610000984099.
J Drugs Dermatol. 2012;11(3):349-354. 2012;11(3):349-354.
Second Lieutenant Jason Boyd BS, Major Steven Sloan MD, Colonel Jeffrey Meffert MD| |
Theodore Rosen MD,a Sheila Fallon Friedlander MD,b Leon Kircik MD,c Matthew J. Zirwas MD,d
Linda Stein Gold MD,e Neal Bhatia MD,f Aditya K. Gupta MD PhD MBAg
J Drugs Dermatol. 2015;14(3):223-228.
Leon H. Kircik MD| |
J Drugs Dermatol. 2013;12(suppl 6):s73-s76.
Rapid Treatment of Subungual Onychomycosis Using Controlled Micro Nail Penetration and Terbinafine Solution
Ivan Bristow PhD,a Robert Baran MD,b and Michelle Score BSc (Hons)c| |
J Drugs Dermatol. 2016;15(8):974-978.
Samreen Z. Choudhry MD,a Neal Bhatia MD,b Roger Ceilley MD,c Firas Hougeir MD,d
Robert Lieberman MD,e Iltefat Hamzavi MD,a and Henry W. Lim MDa
J Drugs Dermatol. 2014;13(2):148-153.
Brad A. Yentzer MD and Alan B. Fleischer Jr. MD| |
J Drugs Dermatol. 2012;11(10):e35-e38.
Hilary E. Baldwin MD,a Neal D. Bhatia MD,b Adam Friedman MD,c Richard Martin Eng,d and Sophie Seité PhD e| |
The skin is constantly exposed to various endogenous and exogenous factors that may impact its barrier function at the physical, mechanical, immunological, and microbial levels. These factors have the potential to initiate or exacerbate a variety of inflammatory skin conditions, especially those associated with barrier dysfunction. The barrier function of the skin depends upon a symbiotic relationship between resident microbial communities and host tissue. This symbiosis results from complex signals involved in both the innate and adaptive immune responses. Recent research indicates that both bacterial diversity and the relative abundance of different microbes present on and in the skin, may contribute to skin barrier stability or dysfunction. The objectives of this review are to discuss the relationship between the skin microbiota and skin barrier function and to consider mechanisms that may help its preservation.
J Drugs Dermatol. 2017;16(1):12-18.
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William R. Levis MD, Aton M. Holzer MD, Leonard L. Kaplan PhD| |
Kathani Amin MD, Christy C. Riddle MD, Daniel J. Aires MD, Eric S. Schweiger MD| |
Wendy C. Cantrell DNP CRNP and Boni E. Elewksi MD| |
METHODS: Ketoconazole 2% foam was evaluated in a single-center, open-label, one-arm pilot study which enrolled eleven subjects to gain 10 evaluable subjects aged 21 years and older with a clinical diagnosis of tinea versicolor and positive KOH using calcofluor. The subjects came for 4 scheduled visits (baseline, week 1, week 2, and week 4) and were instructed to apply ketoconazole 2% foam to all affected areas twice daily for 2 weeks. At each visit, mycological and clinical assessment of a target area was done, along with static global assessment and body surface area estimation of the disease in each subject. Patient questionnaires were given at baseline and at week 2 to rate pruritus and satisfaction with the foam.
RESULTS: At the week 2 visit, following the treatment period, three out of ten evaluable subjects had negative skin samples prepared with KOH/calcifluor. Of these three, one subject later showed recurrence of fungal elements consistent with tinea versicolor at the week 4 follow-up visit. The other negative subjects remained negative and four additional subjects tested negative at week 4. Three subjects with positive samples at week 4 had only yeast forms without hyphae present. Investigator ratings of the target area were averaged for each clinical feature and demonstrated improvement in scale, hyper- or hypopigmentation, erythema, and induration throughout the study. Average pruritus score increased slightly 1 week after the baseline visit, but then improved steadily over the remaining visits. The investigator’s static global assessment rating showed improvement from mild to moderate disease at baseline to minimal or no disease at week 4 in 7 subjects. The remaining subjects showed neither improvement nor progression of the disease throughout the study. One out of the eleven subjects enrolled did not complete the study. One subject noted mild skin burning sensation after application of medicine. Post-treatment patient questionnaires indicated overall satisfaction with the foam vehicle.
LIMITATIONS: This was a single-arm, open-label, noncomparative trial.
Conclusion: Ketoconazole 2% foam improved overall clinical assessment and microscopic evidence of pityriasis versicolor in all subjects with favorable patient feedback regarding the novel foam vehicle.
J Drugs Dermatol. 2014;13(7):855-859.
Whitney Bowe MD and Mary-Margaret Kober MD| |
Noah Scheinfeld MD JD| |
Mycobacterium Fortuitum Infection Following Adalimumab Treatment for Psoriasis and Subsequent Complication-Free Treatment With Alternate TNF-α Blockers
Michael B. Chang BS, Jennifer C. Sri MD, Marcia Driscoll MD, Anthony A. Gaspari MD| |
J Drugs Dermatol. 2011;10(8):927-929.
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.
Tracey C. Vlahovic DPM| |
J Drugs Dermatol. 2016;15(Suppl 2):s56-59.
Xi Tan PharmD,a Steven R. Feldman MD PhD,b and Rajesh Balkrishnan PhDa| |
J Drugs Dermatol. 2013;12(3):e41-e45.
Aditya K Gupta MD PhD FRCP(C), Jennifer E Ryder HBSc, Richard C Summerbell PhD| |
Tracey C. Vlahovic DPMa and Warren S. Joseph DPM FIDSAb| |
METHODS: A post-hoc analysis of 112 patients, aged 29-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at week 52.
RESULTS: Mycologic cure rates (OC) were significantly greater with efinaconazole (56.5% and 56.3% in diabetic and non-diabetic patients respectively) compared to vehicle (P=0.016 and P<0.001, respectively). The primary end point, complete cure, was also greater for efinaconazole (13.0% and 18.8%, respectively vs 3.7% and 4.7%). Treatment success (percent affected target toenail ≤10%) for efinaconazole was 40.8% and 47.7%, respectively vs 18.5% and 18.2% with vehicle. There was no statistically significant difference between the diabetic and non-diabetic populations for any efficacy endpoint. Adverse events associated with efinaconazole were local site reactions and clinically similar to vehicle.
CONCLUSIONS: Once daily efinaconazole topical solution, 10% may provide a useful topical option in the treatment of diabetic patients with onychomycosis.
J Drugs Dermatol. 2014;13(10):1186-1190.
Kristin Totoraitis BS,a Joel L. Cohen MD,b and Adam Friedman MDc| |
Surgical procedures are an important piece of a dermatologist’s daily practice. Therefore, the optimization of post-surgical wound healing is an area of utmost importance and interest. Although low risk, one notable barrier to proper wound healing is surgical site infection.
In an attempt to mitigate this risk and improve surgical outcomes, multiple topical products continue to be used both pre- and postprocedure. Traditionally, this includes both topical antibiotics and antiseptics. However, these products are not without consequence.
The overuse of topical antibiotics as prophylaxis for infection has contributed to increased bacterial resistance, and in fact is no longer recommended by the American Academy of Dermatology in clean post surgical wounds. Topical antiseptics, including chlorhexidine and povidone-iodine, can have a cytotoxic effect on keratinocytes and may actually impede wound healing as a result. In addition, chlorhexidine in particular can produce both otologic and ocular toxic effects when used on the face. Emerging products, such as hypochlorous acid, may be a potential alternative to the more commonly used agents, as it has effective antimicrobial actions and minimal adverse effects. Therefore, the purpose of this review is to highlight several topical products used to optimize post-surgical wound healing and discuss both their efficacy and safety.
J Drugs Dermatol. 2017;16(3):209-212.
Noah Scheinfeld, MD| |
Histoplasmosis is a well-described opportunistic infection that accompanies human-immunodeficiency virus (HIV) infection. We report an unlikely victim of disseminated histoplasmosis who suffered this infection while on antiretroviral therapy and with a CD-4 count of 525/mm3. Notably, he had a normal chest x-ray and disseminated cutaneous ulcers. The diagnosis was made by skin biopsy, and his infection responded promptly to itraconazole therapy. This case serves as a reminder that the immunological derangements and cutaneous alterations wrought by HIV remain unpredictable in nature and extent.
Prognostic Factors for Complete Cure Following Treatment of Mild and Moderate Toenail Onychomycosis With Efinaconazole Topical Solution 10%
Nathaniel J. Jellinek MD FAAD FACMSa and Andrew Korotzer PhDb| |
METHODS: A subgroup analysis of patients, aged 18 to 70 years, randomized to receive efinaconazole topical solution 10% or vehicle from 2 identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point, complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at week 52 was evaluated based on mycologic cure at week 24, and the degree of clinical improvement in nail involvement at week 12.
RESULTS: Over a quarter (25.1%) of patients treated with efinaconazole topical solution 10% who could demonstrate at least 10% improvement in affected nail involvement by week 12 progressed to complete cures at week 52. Similarly, 21.7% of patients who demonstrated mycologic cure at week 24 achieved complete cures at week 52.
CONCLUSIONS: Early clinical improvement and mycologic clearance may help to predict treatment success with efinaconazole topical solution 10%.
J Drugs Dermatol. 2015;14(8):871-875.
Omar M. Alakloby MD, Salih H. AlJabre PhD, Mohammad Akram Randhawa PhD, Alhusain J. Alzahrani PhD, Khalid M. AlWunais MD, Iqbal A. Bukhari MD| |
The Active Natural Anti-Oxidant Properties of Chamomile, Milk Thistle, and Halophilic Bacterial Components in Human Skin In Vitro
Andrew Mamalis BS,a, b Duc-Huy Nguyen,a Neil Brody MD PhD,c and Jared Jagdeo MD MSa,b,c| |
J Drugs Dermatol. 2013;12(7):780-784.
Leon Kircik MD| |
J Drugs Dermatol. 2012;11(3):313-317.
The Integration of Physiologically-Targeted Skin Care in the Management of Atopic Dermatitis: Focus on the Use of a Cleanser and Moisturizer System Incorporating a Ceramide Precursor, Filaggrin Degradation Products, and Specific “Skin-Barrier–Friendly” Excipients
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2013;12(7 suppl 1):s85-s91
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.
Dina Coronado BS, Tejal Merchant MPharm, Sanjay Chanda PhD, and Lee T. Zane MD| |
J Drugs Dermatol. 2015;14(6):609-614.
Dermatophyte infections account for over 4 million physician visits each year in the United States. Moreover, recent analysis of data from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey for the period from 1995 to 2004 have found that improper treatment of tinea pedis, tinea corporis, and tinea cruris is common and expensive. However, the selection of inappropriate agents is just one impediment to effective care. Therapeutic non-adherence by patients, and especially failure to continue therapy until the infectious organisms are completely eradicated, are additional challenges. Naftifine cream 2% is a topical allylamine antifungal agent for the treatment of superficial dermatomycoses, and this novel topical formulation is a welcome new option. A study of naftifine cream 2% for the treatment of tinea pedis found that 2 weeks of treatment was significantly more effective than vehicle and equivalent to 4 weeks of treatment with naftifine 1% gel. Naftifine 2% cream offers a cosmetically elegant, once-daily topical treatment option for dermatomycoses that may lead to better compliance and better treatment outcome in patients.
Xiang Yang Han MD PhD,a Kurt Clement Sizer MD,a Hiok-Hee Tan MDb| |
Background: A new leprosy-causing species, namely Mycobacterium lepromatosis, was discovered recently to be the cause of diffuse
lepromatous leprosy (DLL) in Mexico. It is unknown whether this organism exists beyond Mexico.
Methods: We sought to determine the identity of the mycobacteria in the skin tissue of two patients from Singapore who died of DLL. DNA was extracted from archived biopsy tissue, and conserved polymerase chain reaction primers were used to amplify and sequence two to three mycobacterial genes in each skin sample.
Results: Both M. lepromatosis and the well-known leprosy agent Mycobacterium leprae were identified in each DLL skin sample. The M. lepromatosis gene sequences from the Singapore cases matched 99.9% with the known Mexican M. lepromatosis strain, but they only matched the corresponding M. leprae sequences by 89.2%.
Conclusions: The new species M. lepromatosis exists beyond Mexico and is the cause of DLL in Singapore. It may cause dual infections along with M. leprae in endemic areas. Archived skin biopsy can be used to differentiate the leprosy agents.
J Drugs Dermatol. 2012;11(2):168-172.
Phoebe Rich MD| |
METHODS: An analysis of 1655 patients, aged 18-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at Week 52. Three groups were compared: those with early disease (<1year), patients with a baseline disease of 1-5 years, and those with long-standing onychomycosis (>5years).
RESULTS: The majority of patients had long-standing disease; were older, male and white. While nail involvement of the target toenail did not differ noticeably amongst the three groups, the number of nails involved did increase progressively with disease duration. Differences were seen in terms of infecting pathogens in early disease that might have important treatment implications. Efinaconazole was more effective in treating early disease, however more than 40% of patients with long-standing disease were considered treatment successes.
LIMITATIONS: A period of 52 weeks may be too brief to evaluate a clinical cure in onychomycosis.
CONCLUSIONS: Treatment of onychomycosis early to avoid disease progression to other toenails is important. Once daily efinaconazole topical solution, 10% is particularly effective in these patients.
J Drugs Dermatol. 2015;14(1):58-62.
Efficacy and Safety of Once-Daily Luliconazole 1% Cream in Patients ≥12 Years of Age With Interdigital Tinea Pedis: A Phase 3, Randomized, Double-Blind,Vehicle-Controlled Study
Michael Jarratt MD,a Terry Jones MD,b Jeffrey Adelglass MD FACS,c Alicia Bucko DO JD,d Richard Pollak
DPM MS,e Amaury Roman-Miranda MD,f Jason T. Olin PhD,g Leonard Swinyer MD FAADh
OBJECTIVE: This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis.
METHODS: A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days. Efficacy was evaluated at days 28 and 42 (ie, days 14 and 28 posttreatment) based on clinical signs (erythema, scaling, pruritus) and mycology (KOH, fungal culture). The primary outcome was complete clearance at day 42. Safety evaluations included adverse events and laboratory assessments.
RESULTS: Complete clearance at day 42 was achieved in 26.4% (28/106) of patients treated with luliconazole cream 1% compared with 1.9% (2/103) of patients treated with vehicle (P<0.001). Similar safety profiles were obtained for luliconazole cream 1% and vehicle.
LIMITATIONS: This study was conducted in a relatively small population under controlled clinical trial conditions.
CONCLUSION: Luliconazole cream 1% applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis.
J Drugs Dermatol. 2014;13(7):838-846.
Shawn Shetty MD and A. Razzaque Ahmed MD DSc| |
J Drugs Dermatol. 2013;12(6):672-677.
Ciclopirox vs Amorolfine: In Vitro Penetration Into and Permeation Through Human Healthy Nails of Commercial Nail Lacquers
Daniela Monti PhD,a Silvia Tampucci PhD,a Patrizia Chetoni PhD,a Susi Burgalassi PhD,a and Federico Mailland MDb| |
J Drugs Dermatol. 2014;13(2):143-147.
Oregano Extract Ointment for Wound Healing: A Randomized, Double-Blind, Petrolatum-Controlled Study Evaluating Efficacy
Jennifer Ragi MD,a Amy Pappert MD,a Babar Rao MD,a Daphna Havkin-Frenkel PhD,b Sandy Milgraum MDa| |
Background: Wound healing is a dynamic and complex process affected by tissue hydration, the presence of bacteria, inflammation, and other variables. Oregano has potent antibacterial, antifungal, antioxidant, and anti-inflammatory properties. Studies of oregano ointment
on wound healing are lacking.
Objective: To determine the efficacy of 3% oregano extract ointment on wound healing.
Methods: An investigator initiated, randomized, double-blind, petrolatum-controlled study was performed to determine the effects of oregano ointment on wound healing. Forty patients who underwent surgical excision were enrolled and randomized. Cultures were obtained on day 12 and scars were evaluated using the Patient and Observer Scar Assessment tool on day 12, 45, and 90.
Results: The oregano ointment group had 19 percent of cultures test positive for Staphlococcus aureus compared to 41 percent in the petrolatum group. One patient in the oregano ointment group developed a cellulitis compared to three patients in the petrolatum group. The oregano group had a statistically significant improvement over petrolatum in scar color, pigmentation, and pliability.
Conclusion: Oregano extract ointment decreased bacterial contamination and subsequent infection on post-surgical wounds and had equivalent overall scar appearance compared to petrolatum.
J Drugs Dermatol. 2011;10(10):1168-1172.
Craig Leonardi MD, Bruce Strober MD PhD, Alice B. Gottlieb MD PhD, Boni E. Elewski MD, Jean-Paul Ortonne MD, Peter van de Kerkhof MD, Chiun-Fang Chiou PhD, Meleana Dunn MA, Angelika Jahreis MD PhD| |
Elizabeth M. Grossman MD MBA,a Shivani Nanda BS,a Jennifer R.S. Gordon MD,a Meghan Dubina MD,aAlfred W. Rademaker PhD,b Dennis P. West PhD,a and Peter A. Lio MDa
aDepartment of Dermatology and bDepartment of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL
Observations: Adult healthcare workers within an academic-centered hospital (n=216) were screened via nasal swab with culture for S aureus colonization. Forty-five subjects (20.8%) screened positive for S aureus; of these subjects, 3 (1.4%) were positive for MRSA. Of the 45 subjects with positive cultures, 30 completed 5 days of twice-daily intranasal TAO application. One week after treatment, all 30 subjects were reswabbed; 16 (53.3%) showed evidence of decolonization on repeat culture.
Conclusions: The rate of S aureus colonization of healthcare workers in our study is lower than published rates in industrialized nations. Intranasal application of TAO may be a viable option for eradication of nasal colonization by methicillin-susceptible S aureus in environments where mupirocin-resistant bacterial strains become more prevalent.
J Drugs Dermatol. 2012;11(12):1490-1492.
Access of Efinaconazole Topical Solution, 10%, to the Infection Site by Spreading Through the Subungual Space
Boni E. Elewski MD,a Richard A. Pollak, DPM MS,b Radhakrishnan Pillai PhD,c Jason T. Olin PhDd| |
METHODS: 11 patients (mean age 48.5 years) were entered with clinically determined onychomycosis. Presence of fungal infection was confirmed by KOH testing in eight patients. Two separate applications of vehicle (with fluorescein incorporated for better visualization) were applied at the hyponychium, avoiding application to the exterior nail plate surface. Affected nails were later clipped to allow examination of the nail bed and further examination of the underside of the nail. Spread of formulation was assessed under visible and UV light conditions by photographing target toenails after vehicle application, and after nail clipping.
RESULTS: Assessments under both visible and UV light indicated that the vehicle had spread into the subungual space, with deposition of flourescein wherever vehicle had reached, including in the nail bed. Nail clippings also indicated deposition to the underside of the nail plate.
LIMITATIONS: The relative contributions of spreading into the subungual space, or permeation through the nail plate to the efficacy of efinaconazole topical solution, 10% in treating onychomycosis were not assessed.
CONCLUSIONS: This study suggests that the vehicle developed for efinaconazole topical solution, 10%, when applied at the hyponychium, spreads into the subungual space between the nail plate and nail bed, reaching the site of infection.
J Drugs Dermatol. 2014;13(11):1394-1398.
Kourosh Beroukhim BS,a Melissa J. Danesh BS,b Catherine Nguyen BS,c Annemieke Austin MD,b John Koo MD,b and Ethan Levin MDb| |
METHODS: We reviewed the results of the phase II clinical trials for the anti-IL-23 agents tildrakizumab and guselkumab, in order to assess the efficacy and safety profile of each agent.
RESULTS: By week 16, the proportion of patients achieving Physician Global Assessment (PGA) score of clear (0) or minimal (1) and Psoriasis Area and Severity Index (PASI 75) was above 70% among the most efficacious dosage of each agent (P< 0.001 compared to placebo for all agents). The safety profiles of the agents were similar, with the most frequently reported adverse events of nasopharyngitis, upper respiratory infections, cough, and headache.
CONCLUSION: The anti-IL-23 agents demonstrated a rapid clinical improvement and favorable short-term safety profile. The results of the phase II trials support IL-23 as an essential target in psoriasis treatment.
J Drugs Dermatol. 2015;14(10):1093-1096.
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.
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.
Stuart Maddin MD,a John Quiring PhD,b and Lynne Bulgerc| |
METHODS: This phase 3, randomized, placebo-controlled trial investigated the noninferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsules dosed QD for 12 weeks, with a 40-week follow-up period. Clinical Cure (Investigator’s Global Assessment plus mycological examination) was the primary outcome measure and Clinical Improvement was a secondary endpoint. Safety and efficacy of itraconazole 200-mg tablets were also compared with placebo.
RESULTS: Significantly more patients in the intent-to-treat per-protocol populations on itraconazole (200-mg tablet or 2 100-mg capsules) achieved Complete Cure and Clinical Improvement compared with placebo. For both endpoints, itraconazole 200-mg tablet QD was noninferior to itraconazole 100-mg capsules and superior to placebo. All treatment groups demonstrated a similar safety profile with no new safety signals identified.
LIMITATIONS: Absolute patient blinding was not possible; the number of tablets versus capsules differed, and the appearance of the active drugs could not be masked. However, efficacy was based on objective assessments from blinded investigators.
CONCLUSIONS: Once-daily itraconazole 200-mg was well-tolerated, and may be an effective alternative to 2 itraconazole 100-mg capsules for the treatment of toenail onychomycosis. The convenience of a simpler dosing regimen may improve patient compliance (ClinicalTrials.gov number, NCT00356915).
J Drugs Dermatol. 2013;12(7):758-763.
Benjamin Farahnik BA,a Kourosh Beroukhim BS,b Mio Nakamura MD,c Michael Abrouk BS,d Tian Hao Zhu BA,e Rasnik Singh BS,b Kristina Lee BA,c Tina Bhutani MD,c and John Koo MDc| |
METHODS: We reviewed the results of the phase III clinical trials for the anti-IL-17 agents secukinumab, ixekizumab and brodalumab in order to assess the efficacy and safety profile of each agent.
RESULTS: By week 12, the proportion of patients reaching a 75% improvement from baseline Psoriasis Area and Severity Index (PASI 75) was comparable between the different agents (secukinumab 83%, ixekizumab 89%, and brodalumab 85%). The safety profiles of the agents were similar with the most frequently reported adverse events of nasopharyngitis, upper respiratory infections, headache, and injection site reaction.
CONCLUSION: The anti-IL-17 agents demonstrated a rapid and robust clinical improvement accompanied by a favorable short-term safety profile. The results of the phase III trials continue to reinforce the theory that the IL-17 pathway is an essential target in psoriasis treatment.
J Drugs Dermatol. 2016;15(3):311-316.
E. Victor Ross MD, Michael Swann MD, Seaver Soon MD,Arash Izadpanah MD, David Barnette MD,Scott Davenport BA| |
Background: Traditional full-face resurfacing has been limited to erbium-doped yttrium aluminium garnet (Er:YAG) and carbon dioxide (CO2) lasers. These devices offer wavelength-specific advantages and disadvantages.
Methods: Nine patients were enrolled in a pilot study of a resurfacing system using a 2790-nm erbium:yttrium-scandium-galliumgarnet (Er:YSGG) laser system. Two treatments were carried out 1 month apart over the entire face. Test spots were performed prior to the full-face sessions to determine the optimal fluence for 1-pass laser resurfacing. Biopsies were performed at the time of treatment and at the final follow-up visit one month after the second treatment. Clinical endpoints included changes in pigment dyschromias, wrinkles, and skin tone. All outcomes were graded by blinded observers.
Results: Eight patients completed the 2 treatments. Biopsies showed thermal damage extending as deep as 80 μm below the stratum corneum. Reepithelialization was complete within 4 days. No scarring, post inflammatory hyperpigmentation (PIH), or infections were observed.
Conclusion: A 2790-nm laser can be used for skin rejuvenation with a 4 day recovery window.
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.
Efficacy and Tolerability of Retapamulin 1% Ointment for the Treatment of Infected Atopic Dermatitis: A Pilot Study
Study Design: A single-center, open-label pilot study was conducted to investigate the efficacy and safety of retapamulin 1% (Altabax, Stiefel/ GlaxoSmithKline) ointment for the treatment of secondarily infected atopic dermatitis in subjects aged 9 months to 98 years old (n=29).
Results: Twice-daily application of retapamulin 1% produced a mean 8.1-point reduction from baseline in the mean Skin Infection Rating Scale score. The majority of subjects achieved clinical cure with topical retapamulin therapy. Retapamulin 1% ointment was effective against S aureus isolates, including methicillin-resistant Staphylococcus aureus (MRSA). Treatment was well tolerated.
Conclusion: Retapamulin 1% is effective for the treatment of atopic dermatitis infected with S aureus, and demonstrates efficacy against both methicillin-susceptible and methicillin-resistant strains. Given its efficacy and good tolerability in this pilot study, retapamulin 1% ointment should be further evaluated as a treatment for infected atopic dermatitis. It may provide convenience and efficacy with a low risk for development of bacterial resistance.
J Drugs Dermatol. 2012;11(7):858-860.
Noah Scheinfeld, MD| |
Tuyet A. Nguyen BA BS and Adam J. Friedman MD| |
J Drugs Dermatol. 2013;12(10):1131-1137.
Maria Rita Nasca MD PhD,a Francesco Lacarrubba MD,a Francesco Ferraù MD,b and Giuseppe Micali MDa| |
J Drugs Dermatol. 2016;15(6):766-768.
Abbas Rasi MD, Ashkan Heshmatzade Behzadi MD, Siamak Davoudi MD, Parviz Rafizadeh MD, Yasamin Honarbakhsh MD, Mahsa Mehran MD, Pirouz Piran MD, Nasir Dehghan MD| |
James R. Schwartz PhD| |
J Drugs Dermatol. 2016;15(2):140-144.
Transungual Delivery of Efinaconazole: Its Deposition in the Nail of Onychomycosis Patients and In Vitro Fungicidal Activity in Human Nails
Misao Sakamoto MS,a Noriaki Sugimoto MS,b Hideki Kawabata MS,a Eiko Yamakawa MS,a
Nobuyuki Kodera MS,a Radhakrishnan Pillai PhD,c and Yoshiyuki Tatsumi PhDd
OBJECTIVE: To investigate the transungual delivery of efinaconazole in onychomycosis patients and its fungicidal activity in the toenail.
METHODS: Concentrations of efinaconazole were determined as part of a multi-center, open label study in forty onychomycosis patients following repeated application of efinaconazole topical solution, 5% and 10% to the toenails over 28 days, with a 2-week follow-up. Fungicidal activity against T. rubrum in the ventral layer of human nails was determined using an in vitro human nail infection model (ChubTur®).
RESULTS: Efinaconazole concentrations in the nail were four orders of magnitude higher than MIC values of efinaconazole against dermatophytes. Further, nail drug concentrations were not influenced by the presence of disease or nail thickness, and maintained at high antifungal levels post-treatment. Efinaconazole was effective in reducing fungal viability, suggesting that sufficient amounts of efinaconazole were being delivered into the ventral layer of the nail plate.
CONCLUSIONS: Effective transungual delivery of efinaconazole was demonstrated. The high efinaconazole concentrations in patient toenails and fungicidal activity in vitro potentially contribute to the clinical efficacy reported in phase 3 studies.
J Drugs Dermatol. 2014;13(11)1388-1392.
Lawrence F. Eichenfield MD and Sheila Fallon Friedlander MD| |
Fungal infection of the nails is an increasingly recognized disease in infants and children. However, it can be difficult to distinguish clinically from other nail dystrophies. In addition, many mistakenly believe that onychomycosis does not occur in childhood. Under-recognition of this infectious disorder therefore occurs. Although many consider “nail fungus” a trivial cosmetic concern, it can lead to discomfort, risk of secondary infection, and a more significant health threat in immunocompromised or diabetic individuals. It should always be considered in the differential diagnosis of nail plate disorders in children as it is one of the more common causes.
Here we review the latest data on prevalence of the disease, reasons for its relatively low incidence compared with adults, and important predisposing factors. It is important to confirm the clinical diagnosis of onychomycosis in children, and affected individuals should be examined for concomitant tinea pedis. As familial disease often occurs, it is important to check parents and siblings as well for onychomycosis and tinea pedis.
Treatment of onychomycosis is challenging, and recurrence appears to be more common in children than in adults. Prolonged systemic antifungal therapy is commonly required. However, pediatric practitioners and parents alike hesitate when asked to treat young children with a systemic drug that requires laboratory monitoring and can have systemic toxicities. Due to their thinner, faster-growing nails, children are theoretically more likely to respond to topical monotherapy than adults, and therefore good candidates for topical antifungal therapy.
The clinical data on the use of topical antifungals in pediatric onychomycosis is scarce. We review data that exist from case reports and small clinical trials. New topical antifungals are now available that afford better nail penetration and additional delivery routes to the site of infection. Pediatric trials are now on-going, and should clarify the usefulness of these agents in children.
J Drugs Dermatol. 2017;16(2):105-109.
The Presence of an Air Gap Between the Nail Plate and Nail Bed in Onychomycosis Patients: Treatment Implications for Topical Therapy
Aditya K. Gupta MD PhD FRCPC FAADa,b and Radhakrishnan Pillai PhDc| |
OBJECTIVE: To evaluate the ability of efinaconazole vehicle solution to reach the site of toenail onychomycosis through application to the hyponychium or hyponychium and dorsal nail surface, and assess the impact of the air gap between the nail plate and nail bed.
METHODS: Twenty-three participants with moderate to severe, mycologically-confirmed onychomycosis were enrolled (mean age, 48.5 years). Two separate applications of vehicle solution containing fluorescein for visualization were applied at the hyponychium or hyponychium and dorsal nail surface. Affected nails were later clipped to allow examination of the nail bed and further examination of the ventral surface of the nail. Spread of formulation was assessed under visible and UV light conditions by photographing target toenails after vehicle application and after nail clipping.
RESULTS: There was a positive correlation between the size of the air gap and degree of affected nail involvement (R2=0.064). Assessments under both visible and UV light indicated that the vehicle had spread to the site of infection, with deposition of fluorescein wherever vehicle had reached, irrespective of application methodology or size of air gap. Nail clippings also indicated absorption into the ventral surface of the nail plate.
LIMITATIONS: The relative contributions of subungual versus transungual application of drug to the nail plate to the efficacy of efinaconazole topical solution, 10% in treating onychomycosis were not assessed.
CONCLUSIONS: This study suggests that the low surface tension vehicle developed for efinaconazole topical solution, 10% can reach the site of infection by application to the hyponychium, dorsal or ventral nail surface and nail folds. This multidirectional approach to drug delivery at the site of fungal infection may contribute to the magnitude of efficacy seen in clinical trials.
J Drugs Dermatol. 2015;14(8):859-863.
The Efficacy and Safety of Efinaconazole 10% Solution for Treatment of Mild to Moderate Onychomycosis: A Pooled Analysis of Two Phase 3 Randomized Trials
Aditya K. Gupta MD PhD FRCPC,a,b Boni E. Elewski MD,c Jeffrey L. Sugarman MD PhD,d
Chikara Ieda,e Hideki Kawabata MS,e Robert Kang PhD,f Radhakrishnan Pillai PhD,g
Jason T. Olin PhD,f and Shinichi Watanabe MD PhDh
OBJECTIVES: To investigate the efficacy and safety of efinaconazole 10% solution in pooled Phase III clinical trial participants with mild to moderate onychomycosis.
METHODS: Phase III clinical trials data from NCT01008033 and NCT01007708 were pooled. Efficacy analysis for the primary and secondary outcome variables was conducted using the mITT population and analysed using Cochran-Mantel-Haenszel tests. Subgroup analysis was conducted for prognostic factors that may affect drug efficacy. Safety analysis was conducted on all recipients of a single drug dose.
RESULTS: Efinaconazole 10% nail solution was superior to vehicle for all primary and secondary outcome measures assessed. Complete cure was 18.5% vs 4.7% P<0.001 [mITT] and mycological cure was 56.3% vs 16.6%, P<0.001 [mITT]. Complete or almost complete cure and treatment success were achieved in 27.7% and 47.2% compared to 7.9% and 18.2% with vehicle, respectively (P<0.001 [mITT]). In all subgroups, efinaconazole 10% solution had statistically higher cures rates compared to vehicle. Higher complete cure rates were observed in women and individuals with mild disease (≤33% involvement), but not in any other subgroup assessed. Treatment associated adverse events in the efinaconazole 10% solution group were similar to vehicle and limited to local site reactions (2%).
CONCLUSIONS: The findings from this pooled analysis suggest that efinaconazole 10% solution may become the preferred topical agent for mild to moderate onychomycosis.
J Drugs Dermatol. 2014;13(7):815-820.
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.
David Stocks BSc (Hons),a Hema Sundaram MD,b Jason Michaels MD,c Manzer J. Durrani PhD,d Mitchell S. Wortzman PhD, d Diane B. Nelson BSN MPHd| |
Background: Hyaluronic acid (HA) gels are commonly injected into the skin to lift rhytides and to improve facial appearance. The different processes used in their manufacture and formulation yield products with unique physical characteristics that play an important role in predicting their clinical performance.
Objective: The following rheologic evaluation was performed to objectively measure the physical characteristics of HA dermal filler products derived from similar bacterial sources and containing the same butanediol diglycidyl ether cross-linker, but formulated using different manufacturing techniques. The objective of this study was to evaluate the physical characteristics of two distinct families of HA products, thereby providing clinicians with a greater understanding of these products' attributes and the ability to optimize their use in the treatment of patients seeking facial rejuvenation.
Materials and Methods: The physical properties of commercially-available dermal fillers containing HA were evaluated using rheologic testing methods under clinically-relevant conditions. Additionally, light microscopy was used to assess the particulate nature of each product.
Results: The gels tested demonstrated a broad range of elasticity, firmness and viscosity. Light microscopy confirmed the particulate nature of each product and revealed HA particles of varying size and distribution.
Conclusion: This rheologic evaluation demonstrates that differences exist among the HA products tested including gel elasticity, viscosity, and the range and distribution of gel particle sizes. Understanding the distinct physical characteristics of different HA dermal fillers and how these characteristics may predict their clinical behavior can assist clinicians in achieving the desired results in patients seeking facial rejuvenation.
J Drugs Dermatol. 2011;10(9):974-980.
M.B. Abdel-Naser, U. Wollina MD, M.A. El Hefnawi, M.A. Habib, M. El Okby| |
Computerized Image Analysis of Nails Affected by Fungal Infection: Evaluation Using Digital Photographs and Manually Defined Areas
Robert Baran MD, Adele Sparavigna MD, Michele Setaro, Federico Mailland MD| |
A Retrospective Analysis of 72 Patients on Prior Efalizumab Subsequent to the Time of Voluntary Market Withdrawal in 2009
Elizabeth Farley Prater MD,a Antoinette Day BS,b Mahir Patel MD,c and Alan Menter MDc| |
OBJECTIVE: To review the baseline characteristics and psoriasis phenotypes of patients with prior excelled response to efalizumab, and to determine the response of these patients to prior as well as subsequent therapies. By defining this subgroup of patients, particularly relating to palmoplantar psoriasis, future therapeutic considerations could be improved.
DESIGN: A retrospective review of 72 patients who were on efalizumab at the time of market withdrawal was conducted. Data was obtained through chart review of patients at a specialty psoriasis clinic in Dallas, TX.
MAIN OUTCOMES AND MEASURES: Patient characteristics, details of efalizumab use, and efficacy of efalizumab compared with other psoriasis treatment modalities.
RESULTS: Of the 72 patients, 24 (33%) were found to have palmoplantar disease. As a group, these patients were older, more likely to be female, and less likely to have a family history of psoriasis. 48 patients (67%) were on one or more systemic and/or biologic medication prior to starting efalizumab. Their BSA improved from 5.45 to 0.8 as a group. Six patients were identified as having failed TNF alpha antagonist treatment prior to starting efalizumab. All responded well to the medication with an average BSA of 0.54. Five of these six patients had evidence of palmoplantar disease prior to starting efalizumab and five of these six patients were female. Eleven patients (15%) experienced neurologic side effects and 13 (18%) had infections while on efalizumab treatment.
LIMITATIONS: This was a retrospective review. Quality of life issues could not always be fully assessed from the data available.
CONCLUSIONS AND RELEVANCE: Efalizumab was effectively utilized in our clinical practice to treat patients with palmoplantar psoriasis, including six patients who had failed prior treatment with one or more TNF alpha antagonist agents.
J Drugs Dermatol. 2014;13(6):712-718.
Inflammatory Mediators are Inhibited by a Taurine Metabolite in CpG Oligodeoxynucleotide and IFN-r Activated Macrophage Cell Line
Bo Sook Kim DVM PhD,a Daryl S. Spinner PhD,b Richard J. Kascsak PhD,b Seung Yong Park DVM PhD,c In Soo Cho DVM PhD,d Georgia Schuller-Levis PhD,e and Eunkyue Park PhDe| |
J Drugs Dermatol. 2013;12(5):551-557.
The Subcutaneous Loop: A Single Suture Technique for Skin Closure after Superficial and Subcutaneous Surgery
Sody Abby Naimer MD, Amnon Biton MD, Morris Topaz MD| |
J Drugs Dermatol. 2012;11(8):1000-1002.
The Efficacy and Safety of Tavaborole, a Novel, Boron-Based Pharmaceutical Agent: Phase 2 Studies Conducted for the Topical Treatment of Toenail Onychomycosis
Mirna E. Toledo-Bahena MD,a Alicia Bucko DO JD,b Jorge Ocampo-Candiani MD,c Maira E. Herz-Ruelas MD,c
Terry M. Jones MD,d Michael T. Jarratt MD,e Richard A. Pollak DPM MS,f Lee T. Zane MDg
METHODS: One double-blind, randomized, vehicle-controlled study (study 1) and two open-label studies (studies 2 and 3) examined the efficacy, safety, and optimal dosing concentration of tavaborole topical solution applied once daily or three times weekly for 180 days at concentrations of 1.0%, 2.5%, 5.0%, or 7.5%. Patient cohort 3 of study 2 received open-label tavaborole 5.0% once daily for 360 days. All three studies assessed day 180 treatment success, defined as complete or partial clinical evidence of clear nail growth plus negative fungal culture.
RESULTS: A total of 336 patients were included in the intent-to-treat (ITT) or modified ITT populations and efficacy analyses across the 3 studies. In study 1, treatment success rates at day 180 were higher with tavaborole 2.5%, 5.0%, and 7.5% vs vehicle (27%, 26%, and 32% vs 14%, respectively; slope P=0.030). In cohort 3 of study 2, 7% of patients achieved treatment success with tavaborole 5.0% at day 360. Negative culture rates at day 180 in study 1 were numerically higher for tavaborole 2.5%, 5.0%, and 7.5% vs vehicle (slope P=0.046). Application-site reactions of general irritation, erythema, scaling, and stinging/burning were most common with tavaborole 7.5%, were generally mild to moderate, and resolved with treatment discontinuation and/or a reduction in dosing frequency. No systemic safety concerns were observed.
CONCLUSION: Tavaborole solution demonstrated favorable efficacy and safety in phase 2 clinical studies. Based on these findings, tavaborole topical solution, 5% was further investigated in larger, more definitive phase 3 studies. Results from these completed phase 3 studies will provide additional evidence regarding the safety and efficacy of tavaborole in the treatment of toenail onychomycosis.
J Drugs Dermatol. 2014;13(9):1124-1132.
Nitrosoglutathione Generating Nitric Oxide Nanoparticles as an ImprovedStrategy for Combating Pseudomonas aeruginosa - Infected Wounds
Jason Chouake BA,a* David Schairer BA,a* Allison Kutner BA,a David A. Sanchez BS,b Joy Makdisi BS,a Karin Blecher-Paz MD,a Parimala Nacharaju PhD,c Chaim Tuckman-Vernon BS,cPhil Gialanella MS BS,d Joel M. Friedman MD PhD,c Joshua D. Nosanchuk MD,a,b and Adam J. Friedman MDa,c
J Drugs Dermatol. 2012;11(12):1471-1477.
Isoconazole Nitrate vs Isoconazole Nitrate and Diflucortolone Valerate in the Treatment of Tinea Inguinalis: Results of a Multicenter Retrospective Study
Patients and Methods: Treatment duration was three weeks. The efficacy of the treatment was based on the assessment of several signs and symptoms, which were collected on a 4-point scale. All patients were examined clinically before the beginning of the treatment, one week later, two weeks later, and at the end of the treatment. Mycological examinations were performed before the beginning of the treatment and at the end of the study.
Results: Treatment results with the combination of isoconazole nitrate and diflucortolone valerate were superior regarding erythema and pruritus. Both erythema and pruritus resolved in a larger percentage of patients and more quickly. Both regimens were well tolerated. Mycological cure rates were similar in both groups of patients.
Conclusions: Combination therapy with isoconazole nitrate and diflucortolone valerate is an effective and well-tolerated regimen in adult patients with tinea inguinalis.
J Drugs Dermatol. 2012;11(11)e70-e73.
Topical Minocycline Foam for the Treatment of Impetigo in Children: Results of a Randomized, Double-Blind, Phase 2 Study
Shlomo Chamny MD,a Dan Miron MD,b Nadia Lumelsky MD,c Hana Shalev MD,d Elana Gazal PhD,e Rita Keynan,e Avner Shemer MD,f and Dov Tamarkin PhDe| |
J Drugs Dermatol. 2016;15(10):1238-1243.
Efficacy and Safety of Ustekinumab in Chinese Patients With Moderate to Severe Plaque-type Psoriasis: Results From a Phase 3 Clinical Trial (LOTUS)
Xuejun Zhu MD,a Min Zheng MD PhD,b Michael Song MD,c Yaung-Kaung Shen PhD,dDaphne Chan PhD MHEcon,c Philippe O. Szapary MD MSCE,c and Baoxi Wang MDe on behalf of LOTUS investigators*| |
Objectives: The LOTUS study is a phase 3, double-blind, placebo-controlled study that evaluated the efficacy and safety of ustekinu-mab in Chinese patients with moderate to severe plaque-type psoriasis.
Patients and Methods: Patients (n=322) were randomized to receive ustekinumab 45 mg or placebo at weeks 0 and 4, with placebo crossover to ustekinumab at week 12; all patients were followed up to week 36. The primary end point was the proportion of patients achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) at week 12. Other end points at week 12 included the proportion of patients with a Physician's Global Assessment (PGA) score of 0 or 1 and the change in Dermatology Life Quality Index (DLQI) score from baseline.
Results: At week 12, 82.5% of ustekinumab-treated patients achieved PASI 75 responses compared with 11.1% of placebo-treated patients (P<.001). Clinical responses were maintained through week 28, with maximum responses observed at week 24. Significant improvements in PGA and DLQI were observed at week 12 and were generally maintained through week 28. At week 12, adverse events rates were similar between groups (45 mg: 42.5% vs placebo: 38.5%), and serious adverse events were reported in 0.6% of patients in each group. Through week 36, no cases of active tuberculosis, serious infections, malignancies, or major adverse cardiovascular events were reported.
Conclusions: Consistent with results previously reported in global phase 3 studies, ustekinumab was highly effective and generally well tolerated in Chinese patients with moderate to severe psoriasis through 36 weeks.
J Drugs Dermatol. 2013;12(2):166-174.
Jason Chouake MD,a Aimee Krausz BA,b Brandon L. Adler BA,b Hillel W. Cohen PhD MPH,c
Joshua D. Nosanchuk MD,d,e and Adam Friedman MDb,f
OBJECTIVE: To evaluate the management of skin abscesses by dermatologists.
DESIGN, SETTING, PARTICIPANTS: A national email survey of 780 dermatologists was conducted from May-June 2012. Awareness, experience, and preparedness of respondents for abscess treatment, as well as the treatment practices in different clinical scenarios were evaluated. Response rate = 65% (n=510). Eligibility criteria: board certified/eligible dermatologists practicing in US. Main practice affiliation: solo (20%), group (33%), university health system/academic (32%), multi-specialty (13%), and other (2%). Main practice setting: urban (49%), suburban (42%), and rural (9%).
MAIN OUTCOME and MEASURES: Practitioner report of: awareness of national guidelines, use of I+D in initial management of uncomplicated abscess found on face, trunk, and extremity on patients age 6 months, 3, 15, 50, and 80 years, and use of antibiotics in the initial management.
RESULTS: 99% of respondents were capable of performing I+D in their practice. The IDSA recommends cultures in all patients treated with antibiotic therapy, and does not recommend antibiotics for the treatment of simple abscess. 18% of respondents reported culturing abscesses less than 50% of the time, while 91% incorporated antibiotics into initial treatment. Nearly a quarter (24%) of respondents would choose an initial antibiotic that would not cover Methicillin-resistant Staphylococcus aureus (MRSA). For facial abscesses, as the age of the patient increased from infant, respondents were more likely to incorporate I+D into their initial treatment. For abscesses on the trunk and extremities, respondents were less likely to I+D infants and toddlers, compared to adolescents, adults and the elderly.
CONCLUSION: Although most dermatologists were prepared to manage uncomplicated abscesses (98%), this survey identifies gaps in clinical standards of care established by the CDC/IDSA. Identification of these practice gaps may impact physician practice and dermatology residency curricula, and may serve to improve abscess management and antibacterial stewardship in the outpatient setting.
J Drugs Dermatol. 2014;13(2):119-124.
PSOLAR: Design, Utility, and Preliminary Results of a Prospective, International, Disease-Based Registry of Patients With Psoriasis Who are Receiving, or are Candidates for, Conventional Systemic Treatments or Biologic Agents
Objective: To describe the on-going Psoriasis Longitudinal Assessment and Registry (PSOLAR) study.
Methods: PSOLAR is a large, international, long-term, prospective, disease-based registry enrolling patients with psoriasis who are receiving, or are candidates for, treatment with systemic therapies. The registry fulfills postmarketing regulatory commitments and charges a global Steering Committee to manage epidemiological research on psoriasis and its therapies. Key demographics, disease characteristics, and medication history are collected at enrollment. Adverse events and efficacy data are collected longitudinally.
Results: The August 2011 annual database extract includes 9,495 patients enrolled at 266 global centers. At entry, mean percent of body surface area affected by psoriasis was 12.3% (peak, 29.5%). Approximately 80% of patients were overweight/obese, more than one-third had cardiovascular disease (38.8%) or psoriatic arthritis as captured by the treatment center (37.1%), and over half had received one or two biologic agents (58.8%) or phototherapy (54.8%). Mean duration of participation is 1.3 years, and annual withdrawal rates are less than 6.5%. Of 9,495 patients, 7,476 have been exposed to at least one biologic agent. Serious infections, malignancies, all-cause mortality, and major adverse cardiovascular events (ie, myocardial infarction, stroke, cardiovascular death) occurred at rates of 1.40, 0.61, 0.37, and 0.36 per 100 patient-years of follow-up, respectively.
Limitations: PSOLAR may be subject to limitations common to observational studies (eg, participation bias and potential confounders).
Conclusion: PSOLAR is a disease-based registry designed to assess therapeutic risk and benefit in the general psoriasis population.
J Drugs Dermatol. 2012;11(10):1210-1217.
Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a Phase II/III Multicenter, Randomized, Controlled Trial
Michael David MD,a Dimitar Konstantinov Gospodinov MD,b Nicola Gheorghe MD,c Grisha Stefanov Mateev MD,d Mariyana Venelinova Rusinova MD,e Evgeniya Hristakieva MD,f Laura Gheuca Solovastru MD,g Rita.V. Patel MD,h Calin Giurcaneanu MD,i Mariela Chepileva Hitova MD,j Anca Ioana Purcaru MD,j Beti Horia MD,k Iliya Iliev Tsingov MD,l Rumyana Kaloferova Yankova MD,m Miroslava Ilieva Kadurina MD,n Michal Ramon MD,o Maria Rotaru MD,p Olga Simionescu MD,q Vasile Benea MD,r Zdravka Velichkova Demerdjieva MD,s Maria Rodica Cosgarea MD,t Horia Silviu Morariu MD,u Ziv Michael MD,v Patricia Cristodor MD,w Carmen Nica MD,x Michael H. Silverman MD,y David R. Bristol PhD,y Zivit Harpaz MSc,y Motti Farbstein BSc,y Shira Cohen MSc,y and Pnina Fishman PhDy| |
OBJECTIVE: To evaluate the safety and efficacy of CF101 treatment in a Phase 2/3 study in patients with moderate to severe plaque-type psoriasis.
METHODS: This multicenter, double-blind, 2-segment, placebo-controlled study randomized subjects with moderate to severe plaque psoriasis to CF101 1 or 2 mg, or placebo twice daily. At either week 12 (Segment 1) or 16 (Segment 2), the placebo group crossed over to CF101 BID through week 32 in an open-label fashion. At week 12, following an interim analysis, the CF101 1mg group was discontinued due to futility. The primary endpoint was proportion of patients achieving ≥75% improvement in Psoriasis Area Severity Index (PASI 75). Efficacy testing was performed using the Cochran-Mantel Haenszel test, the primary analysis of PASI 75 was performed at the 0.035 significance level.
RESULTS: CF101 had an excellent safety profile at all tested dosages with a profile similar to the placebo group. The most common adverse events were infections and gastrointestinal events, and there was no cumulative intolerance over the 32-week dosing period. The study did not meet the primary endpoint of PASI 75 at week 12 (2 mg: 8.5% vs. placebo: 6.9%, P=0.621). However, at week 32, PASI mean percent improvement with CF101 2 mg was 57% (P<0.001) compared to baseline, with linear improvement in PASI 50 (63.5%), 75 (35.5%), 90 (24.7%), and 100 (10.6%).
CONCLUSIONS: Oral CF101 was found to be safe and very well tolerated, demonstrating evidence of efficacy in patients with moderate to severe plaque psoriasis through 32 weeks of treatment.
J Drugs Dermatol. 2016;15(8):931-938.
Leon H. Kircik MD| |
Leon H. Kircik MD| |
Oge C. Onwudiwe MD,a Ellen S. Marmur MD,b and Joel L. Cohen MDc| |
J Drugs Dermatol. 2013;12(2):199-205.
Shari R. Lipner MD PhD and Richard K. Scher MD FACP| |
J Drugs Dermatol. 2015;14(5):492-494.
Theresa N. Canavan MD and Boni E. Elewski MD| |
J Drugs Dermatol. 2015;14(suppl 10):s42-s47.
Long-Term Etanercept Use for Severe Generalized Psoriasis in an HIV-Infected Individual: A Case Study
J Drugs Dermatol. 2012;11(3):413-414.
Nima M. Gharavi MD PhD, a* Yasmeen Kabir MDb*, Jennifer L. Hsiao MDa , and Melvin W. Chiu MD MPHa| |
Autumn Bagwell PharmD BCPS, Abbey Loy PharmD BCPS, M. Shawn McFarland PharmD FCCP BCACP BCPS, and Amber Tessmer-Neubauer DPM| |
CASE SUMMARY: A 49 year-old Caucasian female with non-significant past medical history presented to the podiatry clinic for treatment of verrucae. Debridement was performed and monochloroacetic acid was applied to affected areas seven times over seven months. The patient was diagnosed and treated for herpes zoster with acyclovir for ten days. Following acyclovir completion, only one verruca remained with complete resolution at the next follow-up podiatry visit.
DISCUSSION AND CONCLUSION: Few previous trials have supported the use of acyclovir cream in treatment-resistant plantar warts. However, no case reports to date describe the efficacy of oral acyclovir in the treatment of verruca. While a causal relationship has not been solidified between verrucous lesion resolution and treatment with acyclovir, it can be inferred and warrants additional attention.
J Drugs Dermatol. 2016;15(2):237-238.
A Double-Blind, Randomized, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Naftifine 2% Cream in Tinea cruris
J Drugs Dermatol. 2012;11(10):1174-1178.
J Drugs Dermatol. 2012;11(9):1117-1118.
A Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of Naftifine 2% Cream in the Treatment of Tinea Pedis
Lawrence Charles Parish MD,a,b Jennifer L. Parish MD,a Hirak B. Routh MB BS,b Alan B. Fleischer Jr. MD,c Edward V. Avakian MA PhD,c Stefan Plaum MD,c Bhushan Hardas MD MBAc| |
Objective: Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under development in the United States. This randomized,
double-blind, vehicle-controlled, phase 3 trial evaluated the efficacy and safety of two weeks of NAFT-2 treatment in subjects
with tinea pedis. Naftifine 1% cream (NAFT-1) treatment for four weeks and vehicle were also evaluated as a positive control.
Methods: 709 subjects were randomly assigned 2:1:2:1 to one of four treatment groups: (i) NAFT-2 (n= 235), (ii) two-week vehicle (n=118), (iii) NAFT-1 (n=237), or (iv) four-week vehicle (n=119). Efficacy was evaluated at baseline, week 2, week 4, and week 6 and consisted of mycology determination (KOH and dermatophyte culture) and scoring of clinical symptom severity (erythema, scaling, and pruritus). Efficacy was only analyzed in 425 subjects with positive baseline dermatophyte culture. Safety was evaluated by adverse events (AE) and laboratory values in 707 subjects.
Results: At week 6, NAFT-2 subjects achieved 18 percent complete cure rate, 67 percent mycological cure rate, 57 percent treatment effectiveness, 22 percent clinical cure rate, and 78 percent clinical success rate compared to respective vehicle rates of seven percent (one-sided, P<0.01), 21 percent (P<0.001), 20 percent (P<0.001), 11 percent (P=0.04) and 49 percent (P<0.001). Week 6 efficacy responses in NAFT-1-treated subjects were significantly higher than vehicle subjects and almost identical to NAFT-2 subjects. Mycological cure and clinical response rates in both NAFT-2 and NAFT-1 increased from week 2 to week 6. Treatment-related AEs occurred in five percent of NAFT-2 subjects, seven percent of vehicle subjects, four percent of NAFT-1 subjects and eight percent of vehicle subjects. The most common AEs for all groups were application site pruritus and skin irritation.
Conclusion: Topical NAFT-2 for two weeks is safe and provides significantly superior antifungal treatment than vehicle in tinea pedis subjects. NAFT-2 produces equivalent efficacy responses to four weeks of NAFT-1 treatment. The fungicidal activity of naftifine continues to increase for at least one month after treatment is completed. (Clinical Trials Identification Numbe=NCT00750139).
J Drugs Dermatol. 2011;10(11):1282-1288.
A Case of Erythema Elevatum Diutinum With Pancytopenia: Focus on Dapsone-Induced Hematologic Side Effects and Colchicine as a Safe Treatment Option
Emek Kocatürk MD, Bachar Memet MD,
Ilteris Oguz Topal MD, Tülin Yüksel MD,
Pelin Kuteyla Ülkümen MD, Utkan Kızıltaç MD
Scott F. Lindsey BS, Jonathan Weiss MD, Eric S. Lee MD, and Paolo Romanelli MD| |
J Drugs Dermatol. 2014;13(7):869-871.
Detection and Relevance of Naftifine Hydrochloride in the Stratum Corneum Up to Four Weeks Following the Last Application of Naftifine Cream and Gel, 2%
Stefan Plaum MD, Amit Verma DrPH MPH, Alan B. Fleischer Jr. MD,
Babajide Olayinka MSc, and Bhushan Hardas MD
OBJECTIVE: The objective is to use tape stripping methodology to assess the amount of drug available in the SC over a 28 day period following the last dose.
METHODS: This was an open-label, single-exposure study on subjects comparing the amount of drug that was absorbed into the SC following topical application for 2-weeks. Twelve subjects were dosed daily (6 with naftifine cream, 2% and 6 with naftifine gel, 2%). Subjects had twelve 8 cm2 test application sites demarcated on the upper back. Twenty-five individual sequential strips were obtained from each test site. Of these, 11 sites were dosed once daily with the drug (5.0μL/cm2) for days 1 to 14 and the final site served as the control. On days 15, 29, and 43, a site was stripped to collect the SC in order to process the amount of drug present.
RESULTS: Naftifine was present on all tape strip samples collected over the 28 day period following two weeks of application. Furthermore, the most relevant, deeper tape strip sets reflecting the SC, showed potentially clinically relevant presence of naftifine in the skin for 28-days post-treatment.
CONCLUSIONS: Naftifine was present in the tape strips on all sample collection days up to and including four weeks following the last drug application. These findings help explain the progressive improvement in clinical and mycological response rates during the treatment period and for up to four weeks post-treatment in the clinical trials using naftifine.
J Drugs Dermatol. 2013;12(9):1004-1008.
Resident Rounds. Part III: Neutrophilic Eccrine Hidradenitis in the Setting of Acute Myelogenous Leukemia Treated With Cytarabine
Darya Shlapak MBA, Kathyrn Kerisit MD, Christine Lin MD, Alun Wang MD PhD, and Brittany Stumpf MD| |
Justin Finch MD| |
Short-Term and Low-Dose Oral FluconazoleTreatment Can Cause Stevens-JohnsonSyndrome in HIV-Negative Patients
Efi Pasmatzi MD, Alexandra Monastirli MD,Sophia Georgiou MD, George Sgouros MD, Dionysios Tsambaos MD PhD| |
Leon H. Kircik MD| |
Linda F. Stein Gold MD,a Tracey Vlahovic DPM,b Amit Verma DrPH,c Babajide Olayinka MSc,c
Alan B. Fleischer Jr. MDc
OBJECTIVE: The objective of this analysis is to present data from two pooled randomized, vehicle-controlled studies that evaluated efficacy of once daily topical naftifine gel 2% and vehicle at end of treatment (week 2) and at 4 weeks post-treatment in subjects with moccasin tinea pedis.
METHODS: At visit 1, subjects were randomized to naftifine gel 2% or vehicle groups and subjects underwent baseline mycology culture, KOH, and symptom (erythema, scaling, and pruritus) severity grading. Naftifine gel 2% and vehicle treatment were applied once daily for 2 weeks and the subjects returned at weeks 2 and 6 for efficacy evaluation (mycology culture and grading of symptom severity). A total of 1174 subjects were enrolled with interdigital tinea pedis with or without moccasin infection. Of these subjects, 674 subjects had interdigital presentation while 500 subjects had moccasin infection in addition to the interdigital presentation. All 1174 subjects with interdigital presentation satisfied the inclusion criteria of a minimum of moderate erythema and scaling, and mild pruritus. Of the 500 subjects who had moccasin presentation, 380 satisfied the same inclusion criteria as mentioned above. Since data was analyzed as observed cases, between 337 and 349 subjects had data available for analysis of efficacy. Mycologic cure is defined as a negative dermatophyte culture and KOH, treatment effectiveness is defined as mycologic cure and symptom severity scores of 0 or 1, and complete cure is defined as mycologic cure and symptoms severity scores of 0.
RESULTS: At week 6, the cure rates in the naftifine arm vs. the vehicle were statistically higher (P<0.0001) for mycological cure rate (65.8% vs. 7.8%), treatment effectiveness (51.4% vs 4.4%), and complete cure rate (19.2% vs 0.9%).
CONCLUSION: Two weeks application of topical naftifine gel 2% is an effective monotherapy treatment for moccasin tinea pedis.
J Drugs Dermatol. 2015;14(10):1138-1144.
Deborah S. Sarnoff MD FAAD FACP| |
Lucia Seminario-Vidal MD PhD, Wendy Cantrell DNP, and Boni E. Elewski MD| |
J Drugs Dermatol. 2015;14(8):901-902.
Patrick M. O’Shea BS and Aída Lugo-Somolinos MD| |
OBJECTIVE: To compare the efficacy and safety of methotrexate and acitretin in the treatment of chronic hand dermatitis.
METHODS: A chart-retrospective review of all patients with hand dermatitis seen by the primary author at the University of North Carolina Dermatology and Skin Cancer Center from September 2007 to April 2013.
RESULTS: Eighty-three hand dermatitis charts were reviewed. Twenty- nine patients received systemic therapy, of which 17 (26.5%) were treated systemically with acitretin and/or methotrexate. Of these 17 patients, four patients received courses of both acitretin and methotrexate independently after failing the alternative treatment course. At 6 months, acitretin achieved clearance/almost clearance in 44% of patients, compared to 0% of those treated with methotrexate. At 12 months, 100% of patients treated with acitretin achieved clearance/almost clearance compared to 40% of patients treated with methotrexate. Adverse effects were minimal and as expected.
LIMITATIONS: This was a retrospective study, and the small sample size makes it difficult to generalize results.
CONCLUSION: Systemic retinoids are a good alternative for the treatment of chronic hand dermatitis.
Comparative Study of Topical 80% Trichloroacetic Acid With 35% TrichloroaceticAcid in the Treatment of the Common Wart
Fakhrozaman Pezeshkpoor MD,a Mahnaz Banihashemi MD,a Mohammad Javad Yazdanpanah MD,a Hadis Yousefzadeh,b Mohammad Sharghi MD,c Hossein Hoseinzadehd| |
Methods: In this single-blinded clinical trial, 62 eligible patients with common warts referred to the dermatology clinic of Ghaem Hospital in Mashhad, Iran. Patients were randomly divided into two groups, each treated with a TCA solution (group A, TCA 80%; group B, TCA 35%) once per week until complete clearance of the lesions or for a maximum duration of six weeks. Seven patients were excluded from the final analysis (one patient in group A and six patients in group B) for various reasons, including irregular follow-up, using physical tools such as razor blades to remove the lesion, and failure to complete treatment; and 55 patients were included in the final analysis.
Results: Improvement to treatment responses was classified as: no change (no changes in the number of warts), mild (clearing of less than 25% of warts), moderate (clearing of 25% to 75% of warts), and good (clearing of more than 75% of warts). At the end of follow-up, the clinical improvement of group A (n=30) was: 10 patients (33.3%) with a mild response, 6 patients (20%) with a moderate response, and 14 patients (46.7%) with a good response. In group B (n=25), 16 patients (64%) showed a mild response, 6 patients (24%) a moderate response, and 3 patients (12%) a good response. There was a statistically significant difference in improvement between the two treatment groups (P=.017). Improvement was greater with a higher concentration of TCA solution.
Conclusion: This study showed that a different concentration of TCA solution was an effective form of treatment for common warts. Trichloroacetic acid 80% is more effective, but this solution must be used only with careful consideration by a physician.
J Drugs Dermatol. 2012;11(11)e66-e69.
David A. Sanchez BS,a,e Joshua D. Nosanchuk MD,b,c and Adam J. Friedman MDa,d,| |
J Drugs Dermatol. 2015;14(2):127-130.
Background: Upper lip wrinkling is a common complaint of patients seeking perioral rejuvenation. Lately, manual dermabrasion has
become more popular due to its safety, minimal cost, and favorable results. In several hospitals, the ability to efficiently ste rilize
sand paper has been questioned.
Methods: Between 2007 and 2010, 29 patients underwent manual dermabrasion of the skin of the upper lip using an electric cautery scratch pad during their surgeries.
Results: The average patient was aged 60.2 years. The average healing period was 5.8 days. Patient satisfaction from the procedure ranged from very good to excellent. No serious or long lasting complications have been encountered during our follow-up period.
J Drugs Dermatol.2012;11(5):649-652.
Jonathan S. Weiss MD| |
Zoon Balanitis Revisited: Report of Balanitis Circumscripta Plasmacellularis Resolving With Topical Mupirocin Ointment Monotherapy
Michael A. Lee MDa and Philip R. Cohen MDb| |
INTRODUCTION: Zoon balanitis is an idiopathic benign inflammatory condition of the glans penis and prepuce. A patient with biopsy confirmed diagnosis of Zoon balanitis who was successfully treated with topical mupirocin ointment monotherapy is described.
METHOD: A search using PubMed database was performed using the following terms: Zoon balanitis (cases, diagnosis, treatment of), balanitis circumscripta plasmacellularis, and mupirocin. Relevant papers and their reference citations were reviewed and evaluated.
RESULTS: The gold standard of treatment for Zoon balanitis has previously been circumcision. More recently, topical calcineurin inhibitors have been shown to be effective. Our patient had successful resolution of his Zoon balanitis after 3 months of mupirocin ointment monotherapy.
DISCUSSION: Zoon balanitis is a benign inflammatory dermatosis. Previous successful treatment modalities include circumcision, phototherapy, laser therapy, and topical calcineurin inhibitors. Topical mupirocin ointment twice daily resulted in resolution of Zoon balanitis in our patient. Additional evaluation of mupirocin ointment as a therapeutic agent should be considered as a potential first-line therapy in patients with Zoon balanitis.
J Drugs Dermatol. 2017;16(3):285-287.
Resident Rounds. Part I. Program Spotlight: The University of Alabama at Birmingham Department of Dermatology Residency Training Program
James L. Griffith MS,a Johnathan J. Ledet MD,b J. Daniel Jensen MD,b
Jeremy D. Jackson MD,b and Boni E. Elewski MDb
Fatal Cutaneous Strongyloidiasis as a Side Effect of Pemphigus Foliaceus Treatment With Mycophenolate Mofetil
Magalys Vitiello MD,b Michael Shelling MD,a Ivan Camacho MD,a Clara Milikowski MD,a Francisco A. Kerdel BSc MBBSb| |
J Drugs Dermatol. 2011;10(4):418-421.
An Open-Label, Prospective Cohort Pilot Study to Evaluate the Efficacy and Safety of Etanercept in the Treatment of Moderate to Severe Plaque Psoriasis in Patients Who Have Not Had an Adequate Response to Adalimumab
Ronald Vender MD FRCPC| |
Background: The past several years have seen the approval of five different biologic agents for the treatment of moderate to severe
plaque psoriasis in the United States and Canada. Psoriasis has proven to be a difficult disease to treat and treatment failures, even
with newer biologic therapies, are not uncommon. The vast majority of clinical data for these medications is derived from treatment
of biologic-naïve patients, or patients who have not responded to, or lost response to, or not tolerated systemic therapy for psoriasis.
There is currently little data available on therapeutic response of a second biologic therapy after loss of response, or no response,
to the first biologic therapy initiated. It has become common clinical practice to switch medications that are structurally distinct but
therapeutically similar in order to achieve an improved clinical outcome. Therapeutic interchange now is being applied to the biologic
agents used to treat psoriasis.
Objectives: Using a proof of concept study, describe the response of etanercept after adalimumab has failed to produce a satisfactory response in moderate to severe plaque psoriasis.
Methods: A total of 10 biologically naïve patients with moderate to severe psoriasis who were initiated on adalimumab for at least 12 weeks but had a Physician’s Global Assessment (PGA) of mild or worse were transitioned to commercial etanercept 50 mg twice weekly (BIW) for 12 weeks followed by a dose reduction to 50 mg once weekly (OW) for an additional 12 weeks. Ethics approval was obtained and the study registered with ClinicalTrials.gov (NCT00833729). The primary outcome measured was the mean change in Physician’s Global Assessment (PGA) score (range 0-5) from baseline (when the first etanercept injection is given) to 12 weeks of etanercept therapy. The secondary outcomes measures included the mean change in Dermatology Quality of Life Index (DLQI), mean change in body surface area (BSA) covered in psoriasis, Subject’s Global Assessment of disease (SGA), proportion of patients achieving an improvement in PGA score from baseline to 12 weeks and again at 24 weeks and safety.
Results: Overall, there were significant favorable changes in all outcomes measured (PGA, SGA, BSA and DLQI) with respect to etanercept’s efficacy after an inadequate response to at least 12 weeks of adalimumab therapy. There were no significant safety issues noted especially during the transition period from adalimumab to etanercept. ClinicalTrials.gov identifier: NCT00833729.
J Drugs Dermatol. 2011;10(4):396-402.
Ted Rosen MD| |
Herpes labialis remains a common worldwide affliction. Recent advances in understanding the basic pathogenesis have led to new therapeutic intervention, both on-label and off-label. Aside from reducing the duration and symptomatology of acute outbreaks, another goal of treatment is to decrease the frequency of future episodes. Oral and topical acyclovir and its analogues are the mainstay of both chronic suppressive and episodic therapy. A new muco-adhesive formulation of acyclovir provides a decrease in outbreaks, probably due to a diminution of herpesvirus load in all reservoir sites. Acyclovir-resistant strains are rare in immunocompetent hosts; parenteral foscarnet and cidofovir are administered in this situation. Parenteral acyclovir is the drug of choice for eczema herpeticum, which may begin as herpes labialis in an atopic dermatitis patient. Thermotherapy may be beneficial, and a certified device to deliver heat is available outside the United States.
J Drugs Dermatol. 2017;16(3 Suppl):s49-53.
Mariah Johnson MD, Ramin Fathi MD, and Theodore Alkousakis MD| |
Comparison of the Efficacy of Long-Pulsed Nd:YAG Laser Intervention for Treatment of Onychomycosis of Toenails or Fingernails
Yan Li MD, Sisi Yu MS, Jing Xu MS, Ruina Zhang MS, and Junying Zhao BS| |
METHODS: One hundred and twelve affected fingernails or toenails in 37 patients with onychomycosis were randomized into Group 1 (22 patients with 50 affected fingernails) and Group 2 (15 patients with 62 affected toenails). These patients were further classified into three subgroups (Grade II, III, and IV) according to Scoring Clinical Index of Onychomycosis. All the affected nails were treated with long-pulse Nd:YAG 1064 nm laser intervention, once weekly, for continuous weeks, and were followed up for 24 weeks.
RESULTS: The response rates at weeks 8, 16, and 24 were 0, 0 and 52%, respectively, for Group 1, and 10, 32 and 71% for Group 2. The inter-group difference in efficacy was statistically significant (P<0.05). Even in the same subgroup, the response rate of Group 2 was higher than that of Group 1.
CONCLUSIONS: The efficacy of long-pulsed Nd:YAG 1064 nm laser intervention against affected toenails is superior to that against fingernails. It is also effective for treatment of onychomycosis with different severity.
J Drugs Dermatol. 2014;13(10):1258-1263.
J Drugs Dermatol. 2012;11(7):846-851.
Richard K. Scher MD,a Antonella Tosti MD,b Warren S. Joseph DPM,c Tracey C. Vlahovic DPM,d
Jesse Plasencia DPM,e Bryan C. Markinson DPM,f and David M. Pariser MDg
J Drugs Dermatol. 2015;14(9):1016-1021.
Alka Gupta MPharma and Hemanta Kumar Kar MDb| |
METHODS: Miconazole loaded vesicles were prepared by coacervation phase separation technique using nonionic surfactants and stabilizers. The antimycological activity of vesicles was performed using agar disc diffusion technique.
RESULTS: The miconazole nitrate lipid vesicles F5A and F5B showed maximum activity with higher zones of inhibition ie, 13.95+1.54 mm and 13.64+0.65 mm, respectively, after 3 days (For all comparisons, P<.05 was considered significant).
CONCLUSION: The findings of this study suggest antifungal potential of a novel preparation of miconazole nitrate vesicles vs Candida albicans in the treatment of mycoses in dermatological practice.
J Drugs Dermatol. 2016;15(6):734-737.
Anna Kurayev MD and Alice B. Gottlieb MD PhD| |
J Drugs Dermatol. 2016;15(10):1267-1269.
Efficacy and Tolerability Assessment of a Topical Formulation Containing Copper Sulfate and Hypericum perforatum on Patients With Herpes Skin Lesions: A Comparative, Randomized Controlled Trial
Objectives: The study assessed the comparative efficacy and tolerability of a single use, topical formulation containing copper sulfate pentahydrate and Hypericum perforatum that is marketed as Dynamiclear™ to a topical 5% Acyclovir cream standard preparation and use.
Methods: A prospective, randomized, multi-centered, comparative, open-label clinical study was conducted. A total of 149 participants between 18 and 55 years of age with active HSV-1 and HSV-2 lesions were recruited for the 14-day clinical trial. Participants were randomized into two groups: A (n=61), those receiving the Dynamiclear formulation, and B (n=59), those receiving 5% Acyclovir. Efficacy parameters were assessed via physical examination at baseline (day 1), day 2, 3, 8, and 14. Laboratory safety tests were conducted at baseline and on day 14.
Results: Use of the Dynamiclear formulation was found to have no significant adverse effects and was well tolerated by participants. All hematological and biochemical markers were within normal range for the Dynamiclear group. Statistically, odds for being affected by burning and stinging sensation were 1.9 times greater in the Acyclovir group in comparison to the Dynamiclear group. Similarly, the odds of being affected by symptoms of acute pain, erythema and vesiculation were 1.8, 2.4, and 4.4 times higher in the Acyclovir group in comparison to the Dynamiclear group.
Conclusions: The Dynamiclear formulation was well tolerated, and efficacy was demonstrated in a number of measured parameters, which are helpful in the symptomatic management of HSV-1 and HSV-2 lesions in adult patients. Remarkably, the effects seen from this product came from a single application.
J Drugs Dermatol. 2012;11(2):209-215.
Resident Rounds Part III: Case Report: Fatal Cryptococcal Panniculitis in a Lung Transplant Recipient
Bobby Y. Reddy MD,a Sheila Shaigany BS,a Lawrence Schulman MD,b and Marc E. Grossman MD FACPa| |
Cryosurgical Treatment of Warts: Dimethyl Ether and Propane Versus Liquid Nitrogen -- Case Report and Review of the Literature
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| |
Alan B. Fleischer Jr. MDa and Isabelle Raymond PhDb| |
J Drugs Dermatol. 2016;15(9):1111-1114.
Sustained Clinical Resolution of Acquired Epidermodysplasia Verruciformis in an Immunocompromised Patient After Discontinuation of Oral Acitretin With Topical Imiquimod
Rajiv I. Nijhawan MD,a Jeremy M. Hugh MD,b and Achiamah Osei-Tutu MDa| |
J Drugs Dermatol. 2013;12(3):348-349.
Kendra Gail Bergstrom MD FAAD| |
Joseph V. Caravaglio MDa and Amor Khachemoune MD FAAD FACMSb| |
In Vitro Nail Penetration of Tavaborole Topical Solution, 5%, Through Nail Polish on Ex Vivo Human Fingernails
Tracey Vlahovic DPM,a Tejal Merchant MPharm,b Sanjay Chanda PhD,b Lee T. Zane MD,b and Dina Coronado BSb| |
OBJECTIVE: To evaluate the in vitro nail penetration properties of tavaborole topical solution, 5%, through nail polish using ex vivo, non-diseased human fingernails.
METHODS: In study 1, tavaborole penetration was evaluated over 20 days of dosing using the Franz finite dose technique and modified Franz diffusion cells. Nails received either 1 coat of over-the-counter (OTC) typical polish or were left unpolished (controls). In study 2, tavaborole penetration was measured over 14 days of dosing using the finite dose technique and vertical diffusion cells. Nails were polished with either 4 coats or 1 coat of salon typical polish or with 2 coats or 1 coat of OTC typical polish, or they were left unpolished.
RESULTS: In study 1, the mean ± standard deviation (SD) cumulative tavaborole penetration at day 21 was numerically higher, though not statistically significant, through polished nails (3,526 ± 1,433 μg/cm2) vs unpolished nails (2,661 ± 1,319 μg/cm2). In study 2, the mean cumulative tavaborole penetration was also numerically higher (statistical significance not assessed) through all nails that received polish vs unpolished nails. At day 15, mean ± SD cumulative tavaborole nail penetration was 1,179 ± 554 μg/cm2 through 4 coats of salon typical polish, 1,227 ± 974 μg/cm2 through 1 coat of salon typical polish, 1,493 ± 1,322 μg/cm2 through 2 coats of OTC typical polish, 1,428 ± 841 μg/cm2 through 1 coat of OTC typical polish, and 566 ± 318 μg/cm2 through unpolished nails.
CONCLUSION: Results from these in vitro studies demonstrated that tavaborole penetrated through human nails with up to 4 layers of nail polish.
J Drugs Dermatol. 2015;14(7):675-678.
Anne Goldsberry MD MBA,a Alan Dinner PhD, and C. William Hanke MD MPHa| |
J Drugs Dermatol. 2014;13(3):306-307.
Objectives: The primary endpoint was the time to lesion healing.
Methods: 482 subjects with recurrent cold sores were randomized to self-initiate treatment with either vehicle or NB-001 (0.1%, 0.3% or 0.5%) at the first signs or symptoms of a cold sore episode. Lotion was applied 5 times per day, approximately 3 to 4 hours apart, for 4 days. Time to lesion healing was correlated with NB-001 bioavailability determined in human cadaver skin.
Results: Subjects treated with 0.3% NB-001 showed a 1.3-day improvement in the mean time to healing compared to vehicle (P=0.006). This was consistent with human cadaver skin data indicating that the 0.3% nanoemulsion had the highest bioavailability, compared to 0.1% and 0.5% emulsions. No significant safety or dermal irritation concerns or systemic absorption were noted with any of the doses.
Conclusions: Topical NB-001 (0.3%) was well tolerated and highly efficacious in shortening the time to healing of cold sores. The improvement in time to healing was similar to that reported for oral nucleoside analogues, but without systemic exposure. Topical agents for recurrent herpes labialis (cold sores) reduce healing time by one half day, compared to oral therapies that speed healing by a day or more. A topical antiviral nanoemulsion was well tolerated and improved cold sore healing time by over a day compared to vehicle control. Nanoemulsion (NB-001) could represent a more efficacious topical treatment for recurrent cold sores.
J Drugs Dermatol. 2012;11(8):970-977.
Objectives: To determine the prescribing pattern of dermatologists and nondermatologists when treating impetigo and the demographics of the patients treated.
Methods: National Ambulatory Medical Care Survey data on office visits for impetigo were analyzed from 1997 to 2007. Patient demographics and the treatments for impetigo were recorded.
Results: During this 10-year period, dermatologists managed an estimated 274,815 impetigo visits and nondermatologists an estimated 3,722,462 visits. Both dermatologists and nondermatologists most frequently prescribed oral antibiotics to treat impetigo. Topical antibiotics were second most common, and a variety of combination treatments were used.
Conclusions: Oral antibiotics are the most common class of medications used to treat impetigo. There is an opportunity for physicians to take advantage of the equally efficacious topical antibiotics for treating impetigo. A shift towards topical antibiotics would likely decrease morbidity (resulting from adverse effects) associated with use of oral agents.
J Drugs Dermatol. 2012;11(4):489-494.
Brandon L. Adler BA and Adam J. Friedman MD| |
Deborah S. Sarnoff MD FAAD FACP| |
Omer Ibrahim, MD,a Joseph Doumit MD FRCPC,b Alexandra Zhang MDc| |
J Drugs Dermatol. 2015;14(7):750-752.
Lisa Prussick BSc,a,b Natalia Plotnikova MD,a and Alice Gottlieb MD PhDa,b| |
J Drugs Dermatol. 2016;15(6):715-718.
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.
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.
Topical Cyclosporine Versus Emulsion Vehicle for the Treatment of Brittle Nails: A Randomized Controlled Pilot Study
Julian Mackay-Wiggan MD MS,a Jackleen Marji MD PhD,a John G. Walt MBA,b Angela Campbell,a Carol
Coppola,a Bibhas Chakraborty PhD,c David A. Hollander MD MBA,b and Scott M. Whitcup MDb
OBJECTIVE: To assess the efficacy and safety of topical cyclosporine emulsion (CsAE) versus emulsion (vehicle) alone in the treatment of brittle nail syndrome.
RESULTS: Twenty-four patients were randomized to topical CsAE emulsion or emulsion (vehicle) for 24 weeks. Four fingernails of each patient were included; the 2 most severe brittle nails and the second most normal nail were treated with the same medication. The fourth nail, the most normal nail, remained untreated and was used to assess nail growth. The prespecified primary endpoint was change from baseline in Physician Global Assessment (PGA) score (0 to 5 scale) at each follow-up visit. Safety evaluations were conducted at each visit.
RESULTS: In the intent-to-treat population (n=12 for each treatment arm), the PGA score for treated nails improved from baseline (CsAE, 0.7 to 1.4; emulsion, 0.7 to 1.5; P<0.05 for each), with no significant between-group differences. Untreated nails did not improve in overall appearance (0.0 to 0.3 grade; P>0.05). Statistically and clinically significant improvement from baseline was reported for nail length/appearance in both CsAE and vehicle groups.
LIMITATIONS: Sample size was relatively small. The difference in PGA between treated and untreated nails was not analyzed. Baseline disease severity may have been too mild, limiting detection of efficacy.
CONCLUSIONS: Both CsAE and emulsion vehicle applied topically appeared to improve signs and symptoms of brittle nail syndrome and were well tolerated. These findings warrant corroboration in a larger population and inclusion of comparison with an inactive control and a higher concentration of CsAE, the former which may help in distinguishing the efficacy of vehicle emulsion from CsAE.
J Drugs Dermatol. 2014;13(10):1232-1239.
Clinical Evaluation and Quantitative Analysis of Axillary Hyperhidrosis Treated With a Unique Targeted Laser Energy Delivery Method With 1-Year Follow Up
David Caplin MD FACSa and Jordan Austin BSb| |
METHODS: Fifteen subjects were recruited to an approved Institutional Review Board study. Outcome measures were comprised of clinical and quantitative evaluation of functional impairment. This included HDSS scale, physician and subject evaluation, and digital photography of before and after starch iodine tests utilizing image processing and analysis software. Subjects received a single treatment and were evaluated at 1 week and at 3, 6, and 12 months post treatment. Responders were defined as those that scored an HDSS score of 1 or 2 post-treatment. Those that were non-responsive at 6 months received a second treatment.
RESULTS: All patients responded to treatment with 72% reporting a two-point HDSS score improvement and 28% reporting a 1-point improvement at 1-year follow-up. The average HDSS score improvement was 1.9/3.0. Three of the 15 patients at 6 months received a second treatment. The HDSS average score for all patients remained statistically stable at 1-year follow-up.
CONCLUSIONS: Treatment of axillary hyperhidrosis with the 1440nm Nd:YAG-pulsed laser combined with a targeted fiber and temperature-sensing device provides a safe and minimally invasive approach to the treatment of axillary hyperhidrosis with minimal side effects and long-term efficacy.
J Drugs Dermatol. 2014;13(4):449-456.
Aimee Krausz BA and Adam J. Friedman MD| |
Lindsay K. McGuire MD,a Elizabeth K. Hale MD,a and Loyd S. Godwin MDb| |
J Drugs Dermatol. 2013;12(10):1181-1183.
Evaluation of the Appearance of Nail Polish Following Daily Treatment of Ex Vivo Human Fingernails With Topical Solutions of Tavaborole or Efinaconazole
Tracey C. Vlahovic DPM,a Dina Coronado BS,b Sanjay Chanda PhD,b Tejal Merchant MPharm,b and Lee T. Zane MDb| |
METHODS: Twelve ex vivo human cadaver fingernails were cleaned, polished with two coats of L’Oréal® Nail Color, Devil Wears Red #420, and mounted on floral foam. Nails were treated with tavaborole or efinaconazole solutions once daily for 7 days. Dropper and brush applicators were applied to white watercolor paper immediately after dosing to evaluate color transfer from polished nails. On day 7, remaining solutions were transferred to clear glass vials to evaluate color transfer from applicators to solutions. Nails, applicators, and papers were photographed daily following application; remaining solutions were photographed after 7 days of dosing.
RESULTS: Tavaborole-treated polished nails showed no polish discoloration, and tavaborole applicators did not change in appearance during treatment. No color transfer from polished nails was evident to applicator, paper, or remaining solution. Efinaconazole-treated polished nails showed substantial polish changes after the first day of treatment, with polish appearance and discoloration progressively worsening over 7 days of treatment. Color transfer from nails was evident to applicator, paper, and remaining solution.
CONCLUSIONS: Daily dropper application of tavaborole to ex vivo polished nails did not alter polish appearance. Brush application of efinaconazole produced visible changes in polish appearance and color transfer to applicators, paper, and remaining solution. Tavaborole topical solution, 5% may not alter nail polish appearance; the impact of nail polish on tavaborole clinical efficacy has not been evaluated.
J Drugs Dermatol. 2016;15(1):89-94.
Amy E. Rose MD| |
Aditya K. Gupta MD PhD FRCPC a,b and Andrew Korotzer PhDc| |
J Drugs Dermatol. 2016;15(10):1260-1266.
Virginia J. Reeder MD, Cheryl J. Gustafson MD, Scott A. Davis MA,
Alan B. Fleischer Jr. MD,William W. Huang MD MPH
PURPOSE: To investigate trends in the treatment of warts, as well as patient demographics associated with the diagnosis of warts.
Methods: The National Ambulatory Medical Care Survey (NAMCS) was queried for data regarding patient visits associated with the diagnosis of warts from 1990 to 2009.
RESULTS: There was a significant increase in the use of topical imiquimod during the study period, such that it became the most frequently used medication for warts. No statistically significant trends were detected regarding the frequency of treatment with medication only, procedure only, or combination treatment. In terms of patient demographics, there was an upward trend in regards to increasing patient age and the diagnosis of warts. However, there were no significant trends with respect to patient gender or race and the diagnosis of warts.
LIMITATIONS: Warts not otherwise specified (NOS) was the reported diagnosis for more than eighty percent of patient visits for warts. Trends in the treatment of plantar warts could not be evaluated as the ICD-9 code designating this diagnosis was recently instituted in 2009. Data from NAMCS are cross-sectional in nature.
CONCLUSIONS: The advent of a new therapy and shifts in population patterns have modified the epidemiologic profile and treatment of warts.
J Drugs Dermatol. 2013;12(12):1411-1415.
J Drugs Dermatol. 2012;11(10):1200-1206.
Sarina B. Elmariah MD PhDa and Roopal V. Kundu MDb| |
Progressive macular hypomelanosis is an under-recognized disorder characterized by the presence of numerous ill-defined hypopigmented macules and patches on the trunk of young adults. Although common, particularly in Fitzpatrick skin types IV-VI, this condition is frequently misdiagnosed and treated inadequately with antifungals or topical steroids resulting in patient frustration. The exact pathogenesis of progressive macular hypomelanosis is unknown; however, recent studies suggest hypopigmentation results from decreased melanin formation and altered melanosome distribution in response to Proprionibacterium. While there are no well-established or consistently effective therapies for progressive macular hypomelanosis, our growing understanding of its pathogenesis urges consideration of alternative treatment strategies. Here, we report five patients with progressive macular hypomelanosis who benefitted from topical and systemic antimicrobial therapy and summarize the current clinical, pathological and treatment paradigms of this disorder.
J Drugs Dermatol. 2011;10(5):502-506.
Alina Markova MD,a Rene Duquesnoy PhD,b and William Levis MDc| |
Next-generation Biologics in the Management of Plaque Psoriasis: A Literature Review of IL-17 Inhibition
Paul S. Yamauchi MD PhDa and Jerry Bagel MDb| |
J Drugs Dermatol. 2015;14(3):244-250.
Efinaconazole Solution in the Treatment of Toenail Onychomycosis: A Phase 2, Multicenter, Randomized, Double-Blind Study
Eduardo H. Tschen MD,a Alicia D. Bucko DO,a Norihide Oizumi MS, Hideki Kawabata MS,Jason T. Olin PhD, and Radhakrishnan Pillai PhD| |
Objective: We investigated the efficacy and safety of a solution using a novel topical triazole antifungal, efinaconazole, in distal lateral subungual onychomycosis (DLSO). Methods: Multicenter, randomized, double-blind, vehicle-controlled phase 2 study in mild to moderate toenail DLSO (n=135). Subjects randomized (2:2:2:1 ratio) to receive efinaconazole 10% solution (with or without semiocclusion), efinaconazole 5% solution, or vehicle, once daily for 36 weeks, with one 4-week posttreatment follow-up (week 40). Efficacy assessments included complete cure, mycologic cure, clinical efficacy, and other assessments of overall treatment effectiveness. No efficacy variables were designated as primary.
Results: At follow-up, complete cure was numerically higher in all active groups (16%-26%) compared with vehicle (9%). Mycologic cure rates with efinaconazole 10% semiocclusion, efinaconazole 10%, and efinaconazole 5% were 83%, 87%, and 87%, respectively. Efinaconazole 10% (with or without semiocclusion) demonstrated significantly greater clinical efficacy and treatment effectiveness when compared with vehicle (P=.0088 and .0064; .0056 and .0085, respectively, for both efinaconazole 10% groups). Adverse events were generally similar and mild. Local-site reactions were restricted to few subjects and did not differ meaningfully from those produced by vehicle.
Conclusions: This study provided evidence that once-daily efinaconazole 10% solution (with or without semiocclusion) applied topically for 36 weeks was more effective than vehicle in treating DLSO and was well tolerated. Based on these results, efinaconazole 10% solution was chosen for the phase 3 development program.
J Drugs Dermatol. 2013;12(2):186-192.
Aditya K. Gupta MD PhD FRCPC,a Boni E. Elewski MD,b Ted Rosen MD,c Bryan Caldwell DPM,dd David M Pariser MD,e Leon H. Kircik MD,f Neal Bhatia MD,g and Antonella Tosti MDh| |
J Drugs Dermatol. 2016;15(3):279-282.
Yang Yu BS,a,b Jackson Champer MS,a David Beynet MD,a Jenny Kim MD PhD,a,c Adam J. Friedman MDd,e| |
J Drugs Dermatol. 2015;14(5):461-465.
Bensal HP Treatment for Burn and Excision Wounds: An In-Vivo Assessment of Wound Healing Efficacy and Immunological Impact
Jamie Rosen BA,a* Angelo Landriscina BA,a* Anjana Ray PhD,b Lydia Tesfa PhD,b Joshua D. Nosanchuk MD,b and Adam J. Friedman MDc,d| |
J Drugs Dermatol. 2015;14(11):1322-1326.
Here we present the first case of a patient from Ottawa Canada, presenting with leprosy-like illness associated with Mycobacterium lepromatosis. The patient had no history of travel to leprosy-endemic areas or any obvious risk factors. Clinically, the patient presented with an anesthetic maculopapular rash on the trunk, back, and extremities. A skin biopsy of a lesion revealed a dermal lymphohistiocytic infiltration involving the vessels with an inflammatory process extending to the nerves. A neurological exam also identified a severe sensorimotor polyneuropathy. Concurrently, the patient was diagnosed with non-resectable, non small cell carcinoma of the lung, further complicating his clinical presentation. A Kinyoun stain of nasal blows and a Fite stain of the skin biopsy revealed few to moderate acid fast bacilli respectively. Cultures of the skin biopsy and multiple nasal blows were negative. Molecular studies of a skin biopsy sample including sequence analysis of a 765 bp region of the 16s rRNA gene eventually identified the organism with 100% homology to M. lepromatosis. The patient was treated for leprosy and appeared to improve slightly on therapy but died as a result of his malignancy approximately five months after the initiation of therapy. This represents the first case of a patient with M. lepromatosis like illness outside of Mexico and Singapore.
J Drugs Dermatol. 2012;11(2):229-233.
Joy Makdisi BS and Adam Friedman MD FAAD| |
Temporal Association of Herpes Zoster Eruption Post-Aminolevulinic Acid Hydrochloride Photodynamic Therapy for Actinic Keratoses
Katie Manno MDa and Joel L. Cohen MD FAADb,c,d| |
Herpes zoster is a common and painful disease caused by the reactivation of the varicella-zoster virus with a higher incidence and severity associated with increasing age as well as compromised immune status. Acute inciting events for this eruption are not always known, but can include illness, stress, and mechanical injury. Photodynamic therapy (PDT) is a widely used treatment modality for precancerous skin lesions that has not been previously associated with provoking a herpes zoster outbreak. We present a case of herpes zoster eruption occurring after PDT for actinic keratoses in a patient with Non-Hodgkin Lymphoma (NHL).
J Drugs Dermatol. 2017;16(8):817-818.
Ali Alikhan MD and Alison J. Bruce MBBS| |
Postoperative Wound Care After Dermatologic Procedures: A Comparison of 2 Commonly Used Petrolatum-Based Ointments
Adisbeth Morales-Burgos MD,a,b Michael P. Loosemore MD, a,band Leonard H. Goldberg MDa-c| |
J Drugs Dermatol. 2013;12(2):163-164.
Neal Bhatia MD| |
J Drugs Dermatol. 2013;12(7):796-798.
Lichenoid Drug Reaction Following Influenza Vaccination in an HIV-Positive Patient: A Case Report and Literature Review
Emily W. de Golian MD,a Christina B. Brennan MD,b and Loretta S. Davis MDb| |
J Drugs Dermatol. 2014;13(7):873-875.
Combined Antibiotic/Corticosteroid Cream in the Empirical Treatment of Moderate to Severe Eczema: Friend or Foe?
Background: Eczema is a common atopic disease associated with pruritus, sleep disturbance, and impaired quality of life. Staphylococcus
aureus colonization/infection is important in its pathophysiology.
Aim: To evaluate the prevalence of S aureus colonization/infection and the efficacy and acceptability of a combined antibiotic/corticosteroid cream in the empirical treatment of eczema.
Methods: Consecutive patients with moderate to severe eczema were recruited. Swab and cultures from the right antecubital fossa and the worst eczematous area, disease severity (SCORAD) and quality of life (Children's Dermatology Life Quality Index, CDLQI), skin hydration (SH), and transepidermal water loss (TEWL) were obtained prior to and following a two week twice-daily course of treatment with a fucidin/corticosteroid cream. General acceptability of treatment (GAT) was documented at completion.
Results: Thirty-five patients (63% males; mean age 13.5, standard deviation 3.6 years; with 21 moderate and 14 severe disease) were recruited. At start, S aureus was isolated from the right antecubital fossa and the worst affected areas in 66% and 71% of these patients, respectively. At completion, S aureus was isolated in 23% and 40% at the antecubital fossae and worst affected areas (P=0.001 and P=0.003, respectively). No methicillin-resistant S aureus was isolated in this series, but the percentage of fucidin-resistant S aureus increased from 8% to 58% (P<0.001). Disease severity and quality of life were significantly improved (pre-Objective SCORAD and post-Objective SCORAD were 38.4±13.7 and 29.7±14.2, P<0.001; pre-CDLQI and post-CDLQI were 9.4±5.2 and 7.1±4.8, P<0.001). At the right antecubital fossa, skin hydration improved from 30.8±14.2 to 36.7±15.2 (P=0.015); and TEWL from 10.7±2.3 to 9.4±2.2 (P<0.001). Eighty percent of patients found the treatment good or very good, and only one (3%) patient found it unacceptable.
Conclusions: The most prevalent organism in moderate to severe eczema was S aureus. Usage of the combined fucidin/corticosteroid cream is convenient and associated with a reduction in disease severity, improvement in quality of life, SH, and TEWL, but caution has to be taken with emergence of fucidin-resistant S aureus.
J Drugs Dermatol. 2012;11(7):861-864.
Adjunctive Trichloroacetic Acid Therapy Enhances Response to Squaric Acid Response to Verruca Vulgaris
J Drugs Dermatol. 2012;11(10):1228-1230.
Interferon- α has been associated with a wide range of adverse events (AEs). A lupus-like reaction at the injection site of subcutaneous (SC) interferon-α is exceptionally rare. A 60-year-old woman with recurrent metastatic melanoma repeatedly developed cutaneous lupus-like reactions at the SC interferon-α-2b injection sites on her thighs. Known features of lupus-like reactions at SC interferon-α injection sites are reviewed, and cutaneous injection site reactions to SC interferon-α are summarized.
J Drugs Dermatol. 2012;11(3):393-398.
Enhancing Transungual Delivery and Spreading of Efinaconazole Under the Nail Plate Through a Unique Formulation Approach
Leon H. Kircik MD| |
J Drugs Dermatol. 2014;13(12):1457-1461.
Jeffrey F. Scott MD, Danyelle Dawes MD, and Kevin D. Cooper MD| |
Material and Methods: sixty AD patients were included in a randomized, double-blind, placebo-controlled trial study. They were randomly divided into two groups and treated for 60 days: group vitamin D (n=30), and placebo group (n=30). The two groups were as follows: Group D, 1600 IU cholecalciferol (vitamin D) and second group placebo. The severity of AD was evaluated based on SCORAD (Scoring Atopic Dermatitis) and TIS (Three Item Severity score) value by the same trained physician before and after the trial.
Results: According to SCORAD and TIS value index in the vitamin D group showed significant improvement in patients with mild, moderate and severe AD (P<0.05) and in patients who the intake placebo, this improvement didn't showed (P>0.05).
Conclusion: Results mention that supplementation with oral vitamin D dramatically improved disease severity in AD patients.
J Drugs Dermatol. 2012;11(3):327-330.
Stephanie A. Steinweg BSa and Anthony A. Gaspari MDb| |
Kristen Lo Sicco MD, Mona Sadeghpour MD, Laura Ferris MD PhD, Lisa Grandinetti MD| |
Cheryl Gray MD,a Sheila M. Greenlaw MD,a Christine Alavian MD,a Karen Wiss MDb| |
Alison Harvey PhD MS and Tu T. Huynh PhD| |
J Drugs Dermatol. 2014;13(4):459-463.
Angelo Landriscina BA,a* Jamie Rosen BA,a* and Adam J. Friedman MDa,b,c| |
J Drugs Dermatol. 2015;14(7):740-744.
Gretchen W. Frieling MD,a Noelle L. Williams BS,b Scott J. M. Lim DO,c and Seth I. Rosenthal MDd| |
J Drugs Dermatol. 2013;12(4):481-484.
Ted Rosen M.D.| |
Within a relatively short period of time after the first antimicrobial drugs were introduced, bacteria began exhibiting varying degrees of resistance. The excessive use (and abuse) of antibiotics in agriculture, and in both human and veterinary medicine, has played a critical causative role in the development of antibiotic resistance, which is now recognized as a global public health threat. Increasing concern over this issue should impact the practice of cutaneous medicine and surgery, as dermatologists can easily adopt new healthcare delivery patterns that might reduce the development of antibiotic resistance and still achieve acceptable treatment outcomes. Dermatologists should seriously consider any and all alternative therapies before committing to an extended course of antibiotic therapy for disease entities that are almost certainly not infectious. Conversely, dermatologists should carefully and closely adhere to dosage and duration recommendations when using antibiotics to treat a bona fide infectious disorder.
J Drugs Dermatol.2011;10(7):724-733.
Whitney P. Bowe MD| |
J Drugs Dermatol. 2014;13(suppl 6):s66-s70.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Alitretinoin (BAL4079) in the Treatment of Severe Chronic Hand Eczema Refractory to Potent Topical Corticosteroid Therapy
Joseph F. Fowler MD,a Ole Graff MD,b Abbas G. Hamedanib| |
J Drugs Dermatol. 2014;13(10):1198-1204.
Taurine Chloramine Inhibits NO and TNF-α Production in Zymosan Plus Interferon-γ Activated RAW 264.7 Cells
Bo Sook Kim,a In Soo Cho,b Seung Yong Park,c Georgia Schuller-Levis,d William Levis,e Eunkyue Parkd| |
Taurine is present abundantly in various tissues, especially in leukocytes embattled to foreign invaders such as microorganisms or oxidants. Taurine-chloramine (Tau-Cl) is produced from taurine at the site of inflammation via the myeoloperoxidase-halide pathway in leukocytes induced by oxidants and/or infectious materials. Previously, our data demonstrated that Tau-Cl inhibited nitric oxide (NO) production and TNF-α secretion induced by lipopolysaccharide (LPS), a Toll-like receptor 4 (TLR-4) ligand or lipoarabinomannan (LAM), a TLR-2 ligand plus interferon-γ (IFN-γ) in peritoneal macrophages or RAW 264.7 cells. Zymosan, a β-glucan of yeast cell wall, is a ligand for TLR-2 and dectin-1 and stimulates macrophages to produce proinflammatory mediators such as NO and TNF-α. Based on our previous data, we examined the effect of zymosan and IFN-γ induced production of NO and TNF-α in the absence or presence of Tau-Cl or taurine using RAW 264.7 cells. Production of NO and secretion of TNF-α is increased when zymosan is combined with IFN-γ. Tau-Cl inhibited production of NO and secretion of TNF-α in zymosan plus IFN-γ activated RAW 264.7 cells in a dose-dependent manner (99% vs. 48% using 0.8mM Tau-Cl). Taurine was without effect. Nitric oxide synthase protein (iNOS), induced by zymosan plus IFN-γ, was inhibited by Tau-Cl (0.8mM) as measured using western blot analysis. NOS mRNA was inhibited by Tau-Cl at four, eight and 16 hours post activation, but not at 24 hours. TNF-α mRNA was inhibited at four hours and eight hours, but not at 16 and 24 hours. These data suggest that expression of both iNOS and TNF-α mRNAs are inhibited by treatment with Tau-Cl within four and eight hours, but not at later time points. Transient suppression of activation of RAW 264.7 cells induced by zymosan may play a critical physiological role for taurine in protecting against tissue injury from initial overt inflammation. This study indicates that tropical treatment of taurine may ameliorate inflammatory dermatoses caused by an environmental yeast or abnormal immune function.
J Drugs Dermatol. 2011;10(6):659-665.
Christina C. Patrone BAa and Larisa J. Geskin MD FAADb| |
Mycosis Fungoides and Sézary Syndrome, the two most common types of Cutaneous T-Cell Lymphoma (CTCL), present many management challenges for dermatologists. Here, we provide a comprehensive review of up-to-date literature, guidelines, and expert clinical insights. We highlight the updates in the World Health Organization Classification of Cutaneous Lymphomas; we summarize the epidemiology, including a recently observed stabilization of increasing incidence of CTCL in the past decade and increased incidence in males, blacks, and veterans; we also provide the most recent updates on prognostic factors for CTCL. Utilization of Next-Generation Sequencing and other novel technologies has shed light on pathogenic mechanisms of CTCL, including immune dysregulation, antigen stimulation, and genomic alterations. CTCL management still remains a significant challenge due to lack of standardization of therapies for every stage of the disease. We provide a straightforward approach to clinical evaluation, diagnostic workup via immunophenotyping and molecular studies, staging guidelines, and select treatment strategies in Mycosis Fungoides and Sézary Syndrome. CTCL patients require individualized, holistic, and multidisciplinary care, for whom addressing management in different skin types and prioritizing quality of life issues are essential.
J Drugs Dermatol. 2017;16(5):405-412.
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.
Safety and Pharmacokinetics of Efinaconazole 10% Solution in Healthy Volunteers and Patients With Severe Onychomycosis: Low Systemic Exposure Suggests Remote Drug-Drug Interaction Potential
Michael Jarratt MD,a William Jo Siu PhD DABT,b Eiko Yamakawa MS,c
Nobuyuki Kodera MS,c Radhakrishnan Pillai PhD,b and Kathleen Smith MBAb
METHODS: Two single-center, open-label studies in healthy volunteers and severe onychomycosis patients. Efinaconazole 10% solution was applied topically to all 10 toenails (0.42 mL total daily dose volume); administered as single and then 7 daily doses to 10 healthy volunteers, and once daily for 28 days to 19 severe onychomycosis patients. Plasma concentrations of efinaconazole and its major metabolite H3 were determined by LC-MS-MS at multiple timepoints. Safety evaluations were carried out throughout both studies.
RESULTS: The mean peak plasma concentrations (Cmax) of efinaconazole and H3 were 0.54 and 1.63 ng/mL, respectively, in healthy volunteers; and 0.67 and 2.36 ng/mL, respectively, in patients. Both parent drug and metabolite accumulated following repeat dosing, and reached steady state in plasma by 14 days. Efinaconazole was well tolerated in both studies; no drug-related adverse events were reported.
CONCLUSIONS: Efinaconazole 10% solution resulted in very low systemic exposures to efinaconazole and H3 when applied topically at maximum use conditions to healthy volunteer and onychomycosis patients’ toenails. Efinaconazole is a CYP inhibitor like other azole antifungals, and its lowest ki is 91 ng/mL for CYP2C9, a >130-fold higher concentration than the mean steady state Cmax observed in patients. The Cmax/ki ratio was 0.007, well below the threshold for clinical DDI evaluation as recommended in regulatory guidances, thereby suggesting efinaconazole 10% solution has remote potential for drug-drug interactions.
J Drugs Dermatol. 2013;12(9):1010-1016.
Colton Nielson BS,b Ryan Fischer MD,a Garth Fraga MD,a and Daniel Aires MDa| |
J Drugs Dermatol. 2016;15(7):894-895.
Leon H. Kircik MD| |
Evelyn J. Cheung MD, Jaroslaw J. Jedrych MD, and Joseph C. English III MD| |
J Drugs Dermatol. 2015;14(10):1161-1162.
Thomas Lee MD, Julia Schwartz MD| |
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.
Kenneth Beer MDa-c
aDepartment of Dermatology, University of Miami, Miami, FL bDepartment of Medicine, Duke University, Durham, NC
cDepartment of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, PA
J Drugs Dermatol. 2012;11(12):1494-1495.
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.
Perry Robins MD| |
Amy Taub MD| |
Resident Rounds. Part III: Erosive and Desquamative Syphilis Associated With Mucositis in the Setting of Acquired Immune Deficiency Syndrome
James Quertermous MS, J. Michael Bernardi MD, Janine Malone MD, Jeffrey P. Callen MD| |
Peter A. Lio MD| |
Review of the Use of a Semisynthetic Bilaminar Skin Substitute in Dermatology and a Case Series Report of Its Utility in Mohs Surgery
Julie Akiko Gladsjo MD PhD, Silvia Soohyun Kim BA, and Shang I Brian Jiang MD| |
J Drugs Dermatol. 2014;13(5):537-541.
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.
Adam Friedman MD| |
Palmoplantar Pustulosis With Fulminant Dystrophic 20-Nail Psoriasis in a Patient Receiving Adalimumab Therapy
Vineet Mishra MDa, Ralph C. Daniel MDb, Craig A. Elmets MDa, Anna Levin MDc, and Boni E. Elewski MDa| |
Euphemia W. Mu MDa and Steven S. Greenbaum MDb| |
The lower cutaneous lip is a highly visible and functionally sensitive unit, and numerous factors must be considered when deciding on the optimal repair for defects in this area. The transposition flap represents an excellent option in the reconstruction of larger lower cutaneous lip defects. We describe the use of random pattern transposition flaps for the repair of lower lateral cutaneous lip defects.
J Drugs Dermatol. 2017;16(4):385-387.
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval. We trust you will find this information beneficial to your practice and research.
Leon H. Kircik MD| |
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
Vineet Mishra MD,a Lee Miller MD,b Salman M. S. Alsaad MD,c and E. Victor Ross MDb| |
METHODS: Five female patients (age range, 30-60) with abdomen striae alba (n=4) and striae rubra (n=1) were enrolled in the study. Skin type distribution among the 5 patients was two type II, one type III, and two type IVs. The device (Accent XL, Alma Lasers Inc.) is a radiofrequency fractional platform (40.68 MhZ) that deploys multiple conical pin electrodes on a moving handheld 6 cogs roller. Four treatments were performed every two weeks with settings based on test spots performed two weeks prior to a full treatment session. Assessment of striae was based on clinical severity of the lesions on a 1-4 scale, with “4” being the most severe. A questionnaire was administered to patients with possible subjective responses ranging from 0-4, with 0 being no improvement and quartiles from 1-4 (1= mild improvement, 2= fair improvement, 3= moderate improvement, and 4= marked improvement, respectively).
RESULTS: Three months after 4 treatments, a mean improvement of 20% was achieved (mean severity score changed from 2.9 to 2.5). Micro-wounds were approximately 200 μm wide on the surface, initially presenting as small gray “dots” and evolving into black dots lasting about 2 weeks. Mean pain was 2/10. Erythema and edema persisted for about one day. No pigmentation abnormalities were observed at the final evaluation. The results from the patient questionnaire revealed a mean score of 2.4/4, thus falling in the range of good to very good.
CONCLUSION: A fractional ablative micro-plasma RF roller device can improve improvement in the appearance of abdomen striae.
J Drugs Dermatol. 2015;14(11):1205-1208.
Anna Kurayev MD, Huda Ashkar MBBS, Ami Saraiya MD, and Alice B. Gottlieb MD PhD| |
J Drugs Dermatol. 2016;15(8):1017-1022.
J Drugs Dermatol. 2012;11(9):1069-1079.
J Drugs Dermatol. 2012;11(8):979-987.
J Drugs Dermatol. 2011;10(12):1370-1375.
Pain Management With a Topical Lidocaine and Tetracaine 7%/7% Cream With Laser Dermatologic Procedures
Joel L. Cohen MD| |
J Drugs Dermatol. 2013;12(9):986-989.
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.
Efficacy and Safety of Aciclovir Mucoadhesive Buccal Tablet in Immunocompetent Patients With Labial Herpes (LIP Trial): A Double-Blind, Placebo-Controlled, Self-Initiated Trial
Thomas Bieber MD,a Olivier Chosidow MD PhD,b Neil Bodsworth MD,c Stephen Tyring MD,d
Jana Hercogova MD,e Mark Bloch MD,f Matthew Davis MD,g Michael Lewis MD,h
David Boutolleau MD,i Pierre Attali MD MSc,j and the LIP Study Group
METHODS: In this multicenter double-blind placebo-controlled patient-initiated trial, 775 patients with recurrent HL were randomly assigned to either a single application of ABT 50 mg or a matching placebo as soon as prodromal symptoms occurred. The primary endpoint was the time to healing (TTH) of primary vesicular lesion (modified intention-to-treat population). Other endpoints included incidence of blocked episodes, duration of herpes episodes, and incidence and time to next recurrence evaluated during a 9-month follow-up period (intention-to-treat population).
RESULTS: With ABT 50 mg, median TTH of primary vesicular lesion was reduced (7 days vs 7.3 days, P=.015), the incidence of blocked herpes episodes was increased by 24.2% (34.9% vs 28.1%; P=.042), and the median duration of herpes episodes was reduced (5.6 days vs 6.4 days, P=.003). During the 9-month follow-up period, recurrence of herpes lesions was less frequent (64.2% vs 73.6%; P=.027) and delayed (205 days vs 165 days, P=.041) in the ABT 50 mg. Both treatments were safe.
CONCLUSION: A single application of ABT improves all endpoints of HL and might modify its clinical course in decreasing the incidence and delaying the onset of the next recurrence.
J Drugs Dermatol. 2014;13(7):791-798.
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.
Reason Wilken MD,a Derek Ho BS,b Tatyana Petukhova MD,a and Jared Jagdeo MD MSa,c,d| |
J Drugs Dermatol. 2015;14(3):303-304.
J Drugs Dermatol. 2012;11(9):e10-e17.
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.
Steven R. Feldman MD PhD| |
J Drugs Dermatol. 2014;13(4):423-427.
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.
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.
Jacqueline E. Greb BA, Caren Garber BA, and Alice B. Gottlieb MD PhD| |
OBJECTIVE: We evaluate disease characteristics and treatment response variation in the moderate-to-severe psoriasis population based on PsA history.
METHODS: Simple-measure for assessing psoriasis activity (S-MAPA) was used to retrospectively analyze treatment responses.
RESULTS: 191 moderate-to-severe psoriatic patients, 58 with and 133 without rheumatologist-diagnosed PsA were analyzed. Regardless of PsA history, S-MAPA improvement was similar with biologic monotherapy (46.2 versus 44.1; P=0.74), traditional systemic monotherapy (62.29 versus 38.12; P=0.22), and combination treatments (64.62 versus 52.71; P=0.40) after 12 weeks. PsA patients on biologic monotherapy experienced a higher infection rate than patients without PsA (0.57% versus 0.19%; P=0.01). PsA patients experienced more adverse events (AEs) associated with traditional systemic monotherapy than biologic monotherapy (3.25 versus 1.04; P=.001).
LIMITATIONS: The relatively small PsA cohort was the primary limitation.
CONCLUSIONS: Patients with moderate-to-severe psoriasis responded similarly to all treatments independent of PsA history. PsA patients received more overall treatments and more biologic monotherapy prescriptions. PsA patients had a greater infection risk on biologic monotherapy compared to those without PsA, and greater adverse events risk on traditional systemic monotherapy compared to biologic monotherapy.
J Drugs Dermatol. 2016;15(8):917-922.
Bensal HP for Second Intention Healing Following Mohs Micrographic Surgery or Shave Skin Biopsy: An Open-label Pilot Study
Breanne Mordorski BA,a Adam J. Friedman MD,b and Leon H. Kircik MDc| |
J Drugs Dermatol. 2016;15(10):1197-1202.
Infliximab is a chimeric monoclonal antibody, which acts by binding to both the soluble and membrane-bound tumor necrosis factor-a. In clinical practice, it is used as either monotherapy or in combination with other systemic therapies, particularly methotrexate. This study reviews clinical response and adverse events in 120 psoriasis patients with moderate-to-severe psoriasis who have received infliximab for a minimum of one year. The medical records of 120 infliximab-treated psoriasis patients at our referral psoriasis clinic in Dallas between 2002-2008 were reviewed for response rates, side effects and concomitant therapies. Of 120 charts reviewed, 112 (93%) patients had plaque type psoriasis, six (5%) had recalcitrant palmoplantar disease and two (1.6%) had severe acropustulosis of Hallopeau. Eighty-four (70%) patients had symptomatic psoriatic arthritis. The mean follow-up time was 2.2±1.1 years. One hundred and nine (91%) of the 120 patients had clearance of their psoriasis (response of more than 90% of initial BSA) at a median time of 12 weeks. Concomitant systemic treatments, primarily methotrexate, were given to 62 (52%) patients. Nineteen patients (16%) discontinued infliximab in the post-one-year treatment period for a variety of reasons, primarily failure to maintain adequate response. One hundred and four (87%) of patients required more than the standard dose of 5 mg/kg every eight weeks to maintain clearance. Infliximab either as monotherapy or in combination with traditional antipsoriatic agents is an effective and well-tolerated treatment option for patients with moderate to severe psoriasis and psoriatic arthritis on therapy for over one year and continuing for the long term.
J Drugs Dermatol. 2011;10(5):539-544.
Program Spotlight: The Unified Division of Dermatology Residency Program of Albert Einstein College of Medicine
Adam Friedman MDa and Steven Cohen MD MPHa| |
Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features The Unified Division of Dermatology Residency Program of Albert Einstein College of Medicine. The editor of Resident Rounds is Omar A. Ibrahimi, MD, PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at firstname.lastname@example.org
Jonathan S. Weiss MD| |
J Drugs Dermatol. 2013;12(suppl 6):s70-s72.
Treatment of Inverse/Intertriginous Psoriasis: Updated Guidelines from the Medical Board of the National Psoriasis Foundation
Hasan Khosravi MD,a Michael P. Siegel PhD,b Abby S. Van Voorhees MD,c and Joseph F. Merola MD MMSca,d| |
Inverse or intertriginous psoriasis commonly involves skin fold areas including the axillae, perianal skin, intergluteal cleft, inframammary, genital/inguinal, abdominal, and retroauricular folds. After reviewing the literature for new treatments, a task force was convened to update a consensus on inverse psoriasis therapy. Short-term treatment continues to be low-potency topical steroids. In order to avoid steroid-induced adverse effects, long-term therapy includes topical immunomodulators, calcitriol, and calcipotriene. Second and third-line therapies include antimicrobials, emollients, and tar-based products. Inverse psoriasis resistant to topical therapy has been shown to respond to botulinum toxin injections, excimer laser therapy, and certain systemic agents (such as anti-TNF and anti-IL12/IL23 therapy). Based on promising results from case reports and prior clinical experience, these systemic agents should be strongly considered in inverse psoriasis resistant to topical therapy. However, they need further evidence-based evaluation. The use of randomized trials and objective severity indices may allow for more robust therapeutic data.
J Drugs Dermatol. 2017;16(8):760-766.
News, Views, & Reviews
The Role of RNA Interference in Dermatology: Current Perspectives and Future Directions
Ife J. Rodney MD, Oge C. Onwudiwe MD, Valerie D. Callender MD, and Rebat M. Halder MD| |
J Drugs Dermatol. 2013;12(4):420-427.
Lucija Kroepfl MBChBa and Jason J. Emer MDb| |
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| |
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.
Salman Bin Dayel MDa and Khalid AlGhamdi MDb| |
Objective: To evaluate the safety and efficacy of alefacept in the treatment of vitiligo.
Methods: After providing informed written consent, 4 adult patients with widespread vitiligo (covering a body surface area ≥5%) were treated with weekly intramuscular injections of 15 mg alefacept for 12 weeks. All patients were monitored clinically, by laboratory investigation, and by digital image analysis. All patients were followed up with for 24 weeks.
Results: All patients tolerated alefacept well, without any adverse events. None of the patients showed any repigmentation. However, 1 patient developed new depigmented patches during treatment with alefacept.
Limitations: A pilot study with a small number of patients.
Conclusion: Alefacept as a monotherapy for vitiligo treatment did not result in any patient improvement, and further evaluation in larger studies may be required.
J Drugs Dermatol. 2013;12(2):159-161.
Topical Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Maintains Efficacy of Etanercept After Step-Down Dose in Patients With Moderate-to-Severe Plaque Psoriasis: Results of an Open Label Trial
Trial Design: In this single-center, open-label study, subjects (n=20) underwent 12 weeks treatment with etanercept 100 mg/week (50 mg, 2x week; weeks –12 to -1), followed by etanercept 50 mg/week maintenance therapy for 40 weeks (weeks 0 to 40). Subjects were followed at four-week intervals. Starting at week 4, subjects who demonstrated an increase from baseline (week 0) body surface area (BSA) of >2% initiated therapy with calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment for four weeks. The study is limited by its small sample size, open-label nature, and lack of blinding.
Findings: Mean BSA involvement decreased significantly from week –12 to 0 with etanercept 50 mg twice a week. At week 4, on the etanercept 50 mg/week dose, mean BSA increased to 9.42±9.39 compared to week 0. With introduction of calcipotriene 0.005%/betamethasone dipropionate 0.064% ointment at week 4, mean BSA decreased to 4.62±8.19 by week 24 and was relatively stable for the remainder of the study period. Similarly, mean PASI (Psoriasis Area and Severity Index) scores improved from week -12 to week 0, increased at week 4, then decreased significantly by week 24 with adjunctive topical treatment.
Conclusion: Topical calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment is a safe and effective adjunct to etanercept 50 mg/week maintenance therapy.
J Drugs Dermatol. 2011;10(8):881-885.
Subhash J. Saxena PhD,a Deysi Duque MS,b and Michael J. Schirripa PhDb| |
METHODS: 85 adult females ages 35-65 with Fitzpatrick skin types I through IV applied the test neck cream twice daily for a 3-month study period. Screening was conducted at Baseline, 2, 30, 60, and 90 days via a virtual trial. Subjects rated satisfaction in each of 4 anti-aging categories including hydration, texture, appearance of wrinkles, and appearance of laxity as well as three product attributes including application, feel, and smell.
RESULTS: Improvement was statistically significant for all measured categories (hydration, texture, appearance of wrinkles, and appearance of laxity) with 94% of study subjects noting improvement in one or more of the measured categories. Further, the quantity of “Satisfied” and “Highly Satisfied” assessments increased 8-fold from baseline with a 94x increase in the quantity of “Highly Satisfied” assessments.
DISCUSSION: The results demonstrate the product’s rapid and continuing ability to improve the self-perceived signs of aging in the neck area including improvement in skin texture on the neck and a reduction in the appearance of wrinkles and laxity along the jawline. Future studies are recommended to determine the primary action mechanisms and to assess the degree of improvement by blinded physician assessment.
J Drugs Dermatol. 2015;14(9):997-1002.
Resident Spotlight. Orlando Dermatology Aesthetic & Clinical Conference (ODAC): Fourth Annual ARTE Poster Competition
Mara Therese P. Evangelista MD, Renita Ahluwalia MD, and Charlotte M. Clark 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.
Efficacy of Topical 4% Quassia amara Gel in Facial Seborrheic Dermatitis:A Randomized, Double-Blind, Comparative Study
Christian Diehl MDa and Alicia Ferrari MDb| |
AIM: To check the efficacy and safety of a topical gel with 4% Quassia amara extract and compare it with topical 2% ketoconazole and 1% topical ciclopiroxolamine in the treatment of facial SD.
METHODS: A group of 60 patients displaying facial SD were randomly distributed in 3 groups and given either a topical gel with 4% Quassia amara extract, a topical gel with 2% ketoconazole, or a topical gel with 1% ciclopirox olamine for 4 weeks. Disease severity was assessed at the start and weekly along treatment, as well as 4 weeks after the end of treatment. In each selected area, severity of erythema, scaling, pruritus, and papules were scored from 0 to 3, the sum of these values representing the score of SD on the face. This evaluation was conducted at each visit. The decrease in SD score with all 3 products was compared at each visit. At each stage, overall improvement, safety, and tolerability were also assessed.
RESULTS: Of the 60 patients, 54 (90%) completed the study. The 3 therapeutic options resulted to be very effective, with a significant advantage in efficacy for 4% Quassia extract. For the other 2 drugs, the results were in line with those previously published in the literature.
CONCLUSION: Topical gel with 4% Quassia extract represents a new, safe, and effective treatment for facial SD.
J Drugs Dermatol. 2013;12(3):312-315.
Multi-Center Clinical Study and Review of Fractional Ablative CO2 Laser Resurfacing for the Treatment of Rhytides, Photoaging, Scars and Striae
Macrene Alexiades-Armenakas MD PhD FAAD,a Deborah Sarnoff MD, Robert Gotkin MD, Neil Sadick MD| |
Laser skin resurfacing has shifted over the past two decades from standard ablative resurfacing to non-ablative resurfacing and most recently, to fractional laser resurfacing. In this most recent category, fractional non-ablative lasers were first introduced followed by fractional ablative lasers, which offer an improved balance between safety and efficacy. In the current article, a review of fractional ablative resurfacing is presented alongside the results from a multi-center clinical study employing the fractional carbon dioxide (CO2) laser (SmartXide DOT, DEKA) for the treatment of rhytides, photoaging, scars and striae distensae.
J Drugs Dermatol. 2011;10(4):352-362.
Peter W. Hashim MD MHS,a Mark G. Lebwohl MD,a Leon H. Kircik MDa,b,c| |
Erin Gilbert MD PhDa and Lucia Calvisi MDb| |
OBJECTIVE: To analyse and discuss the approach to midface as well as lip and perioral volume restoration by two independent dermatologists working in the US and Italy.
METHODS: Seven patients were selected for discussion and divided into two groups: 1) those requiring midface volumization and 2) those undergoing perioral or lip volume replacement. Patients in the midface group were injected with Juvéderm Voluma® XC, Juvéderm® Volift® with lidocaine, Restylane- L®, Perlane-L® or Radiesse®. Patients in the perioral and/or lip group were injected with Juvéderm® Volbella™, with lidocaine, or Belotero Balance™. Patients were photographed before and immediately after injection to evaluate aesthetic outcomes. In each case, filler selection was based upon patient characteristics, anatomical considerations and inherent filler properties.
Results: All patients were extremely satisfied with their treatments. There were no significant immediate or delayed complications following treatment with any of the dermal fillers used.
CONCLUSIONS: Volume restoration in the midface and perioral or lip region can be effectively achieved using a variety of dermal fillers. The dermal filler portfolio available in Europe is exponentially larger than that in the US. Product selection in either market is ultimately the result of the physician’s experience injecting each dermal filler, as well as his or her personal preferences.
J Drugs Dermatol. 2014;13(1):67-74.
J Drugs Dermatol. 2012;11(5):622-625.
John J. Kohorst,a Clinton Hagen,b Christian L. Baum MD,c Mark D. P. Davis MDc| |
OBJECTIVE: We sought to determine the treatments most commonly prescribed and the performance of all systemic and surgical treatments used in hidradenitis suppurativa patients in Olmsted County, Minnesota, treated over a 40-year period.
METHODS: A retrospective chart review was performed to evaluate hidradenitis suppurativa treatments in 376 episodes with 115 Olmsted County patients seen by a clinician at Mayo Clinic in Rochester, Minnesota, between 1968 and 2008. Treatment episode outcomes were recorded from clinical notes for the 73 treatment episodes that had a follow-up period of more than 30 days.
RESULTS: Systemic antibiotics alone were prescribed most frequently in 70.0% of episodes. Systemic antibiotics alone improved 39 of 49 treatment episodes (79.6%), including 13 episodes (26.5%) when the disease was fully cleared. All 5 of 5 episodes (100%) of surgical treatment alone improved, including 4 (80%) in which the disease was fully cleared. Surgery in combination with systemic antibiotic treatment yielded improvement in 5 episodes (71.4%), with 2 episodes (28.6%) showing complete clearance.
CONCLUSION: Systemic antibiotics were the most frequently prescribed treatment type in 115 patients over a 40-year period. Both systemic antibiotic therapy and surgical treatment are effective in disease management.
J Drugs Dermatol. 2014;13(7):827-831.
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.
Sandeep S. Saluja MD, Anneli R. Bowen MD, and Christopher M. Hull MD| |
Ustekinumab Treatment for Psoriasis in 119 Patients Maintained on Therapy for a Minimum of One Year: A Review
Elizabeth G. Wilder MD,a Mahir Patel MD,a Katherine Hebeler BA,b and Alan Menter MDa| |
J Drugs Dermatol. 2014;13(8):905-910.
J Drugs Dermatol. 2011;10(11):1328-1330.
J Drugs Dermatol. 2012;11(11)e55-e60.
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.
Ana Rita Rodrigues-Barata MD and Francisco M. Camacho-Martínez MD| |
OBJECTIVE: To evaluate the type and management of undesirable effects of nonanimal reticulated or stabilized HA observed in our cosmetic unit in the past 3 years.
MATERIALS and METHODS: The consecutive patients using HA attending to our clinic in the past 3 years were divided into 3 categories, according to the time of presentation of the adverse reactions: immediate, early, and late-onset complications. All patients were treated.
RESULTS: Twenty-three patients presented to our clinic complaining of complications after soft tissue augmentation with HA. Ten patients presented immediate-onset complications, 8 showed early-onset complications, and 5 cases complaint of late-onset complications. Treatment of the first group consisted of hyaluronidase injection, massage, and topical antibiotics. Early- and late-onset complications were treated with intralesional triamcinolone acetonide. All patients improved, with the exception of a woman with recurrent granulomas.
CONCLUSION: Generally, undesirable effects of HA (immediate, early, or late onset) are not frequent, and when present, they improve if treated properly. Physicians need to be aware of these possible adverse events in order to establish proper treatment and prevent scarring or other sequelae.
J Drugs Dermatol. 2013;12(4):e59-e62.
Lyn C. Guenther MD FRCPC,a Anneke Andriessen PhD,b Charles W. Lynde MD FRCPC,c John W. P.Toole BSc MD FRCPC,d Gary R. Sibbald MD FRCPC MACP FAAD M.Ed DSc (Hons),e James N. Bergman MD FRCPC,f Marc Bourcier MD FRCPC,g and Ian D.R. Landells MD FRCPCh| |
Successful Treatment of Traumatic Onychodystrophy and Associated Pterygium Unguis With Fractionated Carbon Dioxide Laser: Case Report and Review of the Literature
Derek Ho BS,a,b Andrew Mamalis MD MS,a,b and Jared Jagdeo MD MSa,b,c| |
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.
Anjana Ray PhD,a,* Breanne Mordorski BA,b,* Angelo Landriscina BA,b Jamie Rosen BA,b Joshua Nosanchuk MD,a,c and Adam Friedman MDd| |
J Drugs Dermatol. 2016;15(7):836-840.
Brandon L. Adler BA and Adam J. Friedman MD| |
Jeremy Hugh, MD| |
J Drugs Dermatol. 2012;11(2):160-167.
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2016;15(1 Suppl 1):s11-s16.
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.
Safety Surveillance for Ustekinumab and Other Psoriasis Treatments From the Psoriasis Longitudinal Assessment and Registry (PSOLAR)
Kim Papp MD PhD,a Alice B. Gottlieb MD PhD,b Luigi Naldi MD,c David Pariser MD,d Vincent Ho MD,
e Kavitha Goyal MD,f Steven Fakharzadeh MD PhD,f Marc Chevrier MD PhD,g Stephen Calabro MS,f
Wayne Langholff PhD,g and Gerald Krueger MDh
OBJECTIVE: To assess the risk of adverse events of special interest (AEoSIs) with ustekinumab and other psoriasis treatments in a real-world setting using 2014 Psoriasis Longitudinal Assessment and Registry (PSOLAR) data. AEoSIs included malignancy (excluding nonmelanoma skin cancer), major adverse cardiovascular events (MACE), serious infection, and all-cause mortality.
METHODS: Cumulative rates of AEoSIs/100 patient-years (PY) are reported for ustekinumab, infliximab, other biologics (mostly adalimumab/etanercept), and non-biologics based on pre-specified analyses using attribution rules biased against ustekinumab. Risk factors for AEoSIs, including treatments, were determined using multivariate statistical analysis.
RESULTS: A total of 12,093 patients (40,388 PY) were enrolled in PSOLAR. Overall incidence rates were 0.68/100PY for malignancy, 0.33/100PY for MACE, 1.60/100PY for serious infection, and 0.46/100PY for mortality. Unadjusted rates of serious infection for infliximab (2.91/100PY) and other biologics (1.91/100PY) were numerically higher compared with ustekinumab (0.93/100PY). Exposure to the combined group of biologics other than ustekinumab was significantly associated with serious infection (hazard ratio=1.96, P<.001). None of the biologics was associated with increased risk of malignancy, MACE, or mortality.
LIMITATIONS: Observational data have inherent biases.
CONCLUSION: Analysis of 2014 PSOLAR data identified no increased risk of malignancy, MACE, serious infection, or mortality with ustekinumab.
J Drugs Dermatol. 2015;14(7):706-714.
Magdalene A. Dohil MD| |
J Drugs Dermatol. 2013;12(suppl 9):s128-s132.
E. Eugene Bain III MD,a Shane A. Meehan MD,a Elizabeth K. Hale MDa,b| |
J Drugs Dermatol. 2014;13(5):598-600.
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.
Bryce L. Desmond DO, R. Scott Thomas DO, and Stephanie S. Howerter DO| |
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| |
A Single-Blinded Randomized Controlled Study to Assess the Efficacy of Twice Daily Application of Sinecatechins 15% Ointment When Used Sequentially With Cryotherapy in the Treatment of External Genital Warts
Shelbi C. Jim On MD,a Rita V. Linkner MD,a Madelaine Haddican MD,a Alex Yaroshinsky PhD,b
Matthew Gagliotti BA,a Giselle Singer BS,a and Gary Goldenberg MDa
METHODS: Forty-two subjects with at least two EGW lesions underwent cryotherapy to all lesions. One week following cryotherapy, subjects were randomized 1:1 to receive either no additional treatment or treatment with sinecatechins 15% ointment BID up to 16 weeks or until complete clearance. The total number of visible baseline and new EGW were recorded at each visit. Subjects were followed for a total of 65 weeks post-treatment.
RESULTS: There was a significant reduction in mean number of lesions from baseline after 16 weeks of treatment in the cryotherapy-sinecatechins ointment group compared to cryotherapy alone (-5.0 lesions vs -2.1 lesions respectively, P=0.07).
CONCLUSION: Cryotherapy plus sinecatechins 15% ointment BID resulted in a significant improvement in the reduction of EGW compared to cryotherapy alone. Clinicaltrials.gov registration identifier: NCT02147353
J Drugs Dermatol. 2014;13(11):1400-1405.
Kendra Gail Bergstrom, MD, FAAD| |
Melissa B. Hoffman MD,a Rachna A. Bhandari MD,b and Animesh A. Sinha MD PhDc| |
J Drugs Dermatol. 2016;15(7):821-829.
Deborah S. Sarnoff MD| |
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.
Biologic and Conventional Systemic Therapies Show Similar Safety and Efficacy in Elderly and Adult Patients With Moderate to Severe Psoriasis
Caren Garber BA,a,b Natalia Plotnikova MD,a Shiu-chung Au MD,a Eric P Sorensen BS,a Alice Gottlieb MD PhDa,b| |
METHODS: All patient visits coded for psoriasis or psoriatic arthritis (ICD-9 696.1 or 696.0) at the Tufts Medical Center General Dermatology Clinic from January 1, 2008, to March 1, 2015 were included in this retrospective cohort study. The outcome measure used was the validated simple-measure for assessing psoriasis activity (S-MAPA), the product of the physician’s global assessment and the body surface area.
RESULTS: 194 patients who underwent 278 treatment courses were included in the study. 48 patients were included in the elderly cohort (≥ 65 years old) and 146 in the adult cohort (18-64 years old). There was no significant difference in S-MAPA improvement at 12 weeks between the two cohorts when treated with biologics (42.92% improvement in adults, 48.77% in elderly; P=0.498) or conventional systemics (43.96% and 51.82%, respectively; P=0.448). Within the elderly cohort, there was no significant difference in efficacy of biologics versus conventional systemics at any time point. Topical prescription rates were significantly higher in the elderly cohort (P=0.004) while biologic prescription rates were significantly lower (P=0.014) despite the same baseline S-MAPA in both age groups. For both biologics and conventional systemics, there was no statistically significant intergroup difference in the rate of adverse events (P=0.322 for biologics; P=0.581 for conventional systemics) or infection (P=0.753 for biologics; P=0.828 for conventional systemics). Within the elderly cohort, there was a higher rate of adverse events with conventional systemic treatment than with biologic treatment (P=0.033).
CONCLUSIONS: This study provides preliminary evidence to suggest that biologic and conventional systemic therapies are similarly safe and effective in the elderly and nonelderly cohorts. Within the elderly population, biologics may be a safer option than conventional systemic agents.
J Drugs Dermatol. 2015;14(8):846-852.
Paclitaxel-Associated Subungual Pyogenic Granuloma: Report in a Patient With Breast Cancer Receiving Paclitaxel and Review of Drug-Induced Pyogenic Granulomas Adjacent to and Beneath the Nail
Subungual and periungual pyogenic granuloma occur in association with certain systemic medications. Paclitaxel is an antitumor drug of the taxane family used in the management of breast cancer. Taxanes have many associated nail changes that may occur in patients receiving either docetaxel or paclitaxel for systemic chemotherapy. The nail changes in a 68-year-old woman with metastatic breast cancer who presented for nail changes after receiving 12 cycles of weekly paclitaxel are described herein: nail plate red-brown discoloration, onycholysis with leukonychia, proximal subungual hemorrhage, and subungual pyogenic granuloma. The literature on systemic medications associated with the development of subungual and periungual pyogenic granulomas is reviewed; drugs associated with the development of pyogenic granuloma at the locations include antineoplastics, antiretrovirals, epidermal growth factor receptor inhibitors, immunosuppressants and retinoids. In conclusion, subungual pyogenic granuloma can occur not only in patients receiving docetaxel, but also in patients treated with paclitaxel. And, paclitaxel should be included in the list of drugs associated with the occurrence of subungual pyogenic granuloma
J Drugs Dermatol. 2012;11(2):262-268.
Jay M. Smith MD,a J. Erin Reid MD,b and Morgan L. Wilson MDa| |
Nikki Vyas BS,a Nishit S. Patel MD, band George F. Cohen MDb| |
J Drugs Dermatol. 2013;12(2):210-216.
John R. Griffin MD and Mark D.P. Davis MD| |
J Drugs Dermatol. 2015;14(2):115-118.
Andrew C. Krakowski MD,a Lawrence F. Eichenfield, MDb| |
News, Views, & Reviews
Manifestations and Treatment of Cutaneous Lupus Erythematosus (Part II of II)
David Schairer BA and Adam Friedman MD| |
J Drugs Dermatol. 2012;11(9):1053-1058.
Breanne Mordorski BA,a Adam Friedman MD,b George Han MD PhDc| |
J Drugs Dermatol. 2016;15(9):1132-1135.
aPeter K. Lee MD PhD and bAndrew Kloser PhD| |
J Drugs Dermatol. 2013;12(8):925-930.
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.
Letter to the Editor: The New Face of Fillers: Integrating Evidence, Experience and a Little Imagination at the Next Frontier
Hema Sundaram MD| |
Erythema Nodosum-like Septal Panniculitis Secondary to Lenalidomide Therapy in a Patient With Janus Kinase 2-Positive Myelofibrosis
Tatyana A. Petukhova MD MS, a,b Danielle M. Tartar MD PhD,a,b Karen Mayo MSN FNP-BC OCN,b Maxwell A. Fung MD,a Joseph Tuscano MD,a,b and Jared Jagdeo MD MSa.b| |
J Drugs Dermatol. 2016;15(8):1024-1025.
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.
Systematic Review of Vismodegib Toxicity Profile in the Treatment of Advanced Basal Cell Carcinomas Compared to Other Systemic Therapies in Dermatology
Margit L.W. Juhász MSca and Ellen S. Marmur MDa,b| |
J Drugs Dermatol. 2014;13(6):729-733.
Robin Lewallen, MD| |
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.
Combination Use of Ustekinumab With Other Systemic Therapies: A Retrospective Study in a Tertiary Referral Center
Gillian M. Heinecke BS, Adam J. Luber BA, Jacob O. Levitt MD, and Mark G. Lebwohl MD| |
OBJECTIVE: To evaluate the prevalence, indications, and response to combination systemic therapy with ustekinumab for psoriasis in a tertiary referral center.
METHODS: This retrospective study comprised 102 psoriasis patients treated with ustekinumab at a single tertiary care center. Data was collected pertaining to history of psoriasis, past and current therapies including use of concomitant psoriasis agents, response to therapy, and side effects while on ustekinumab.
RESULTS: Twenty-two of 102 (22%) patients were identified as receiving combination systemic treatment involving ustekinumab and at least one additional agent. The most common indication for combination therapy was psoriatic arthritis (35%), followed by bridging therapy (26%), inadequate psoriasis control (13%), prevention of non-melanoma skin cancers (17%), and control of palmoplantar disease (9%). Methotrexate was the additional agent in 12 patients, cyclosporine in 7 patients, acitretin in 5 patients, and 1 patient received a second biologic agent, first etanercept and then adalimumab. Overall, the reduction in body surface area (BSA) was 80% for patients on combination therapy. For those patients on combination therapy for psoriatic arthritis, 75% had resolution or stabilization of their symptoms. Only one patient, receiving cyclosporine, discontinued combination therapy due to adverse side effects.
CONCLUSION: Combination systemic therapy with ustekinumab can be effective and well tolerated for patients who cannot be adequately treated with ustekinumab alone.
J Drugs Dermatol. 2013;12(10):1098-1102.
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.
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.
Secukinumab Self-Administration by Prefilled Syringe Maintains Reduction of Plaque Psoriasis Severity Over 52 Weeks: Results of the FEATURE Trial
Alice B. Gottlieb MD PhD,a Andrew Blauvelt MD MBA,b Jörg C. Prinz MD,c Philemon Papanastasiou PhD,d Rashidkhan Pathan MS,e Judit Nyirady MD MBA,f Todd Fox PharmD ACPR,d Charis Papavassilis MD PhDd| |
J Drugs Dermatol. 2016;15(10):1226-1234.
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.
Skin Barrier Health: Regulation and Repair of the Stratum Corneum and the Role of Over-the-Counter Skin Care
Thomas Lee MD and Adam Friedman MD| |
J Drugs Dermatol. 2016;15(9):1047-1051.
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.
Safety and Effectiveness of Ustekinumab for Treatment of Moderate to Severe Psoriasis: A Prospective Study in a Clinical Setting
Alejandro Molina-Leyva MD, Husein Husein-Elahmed MD, Ramon Naranjo-Sintes PhD,
and Jose Carlos Ruiz-Carrascosa MD
OBJECTIVE: To assess the utility of ustekinumab in a psoriasis unit.
METHODS: Analysis of the prospective data gathered during the follow-up of 30 consecutive psoriasis patients treated with ustekinumab at a single referral centre. Three effectiveness endpoints were defined 12 weeks, 28 and “long-term treatment”. The main outcome measure was improvement from baseline PASI at week 28 and at a point of adjustment of prolonged treatment signed as “long-term treatment”.
RESULTS: Overall 82.1% and 42.8% patients achieved respectively PASI75 and PASI90 response rates at week 28. Long-term treatment maintained efficacy outcomes 81.5% and 40.7% PASI75 and PASI90, respectively were observed. At week 28, patients naïve to TNFα- blockers agents and patients with a baseline PASI >10 had better PASI75 and PASI90 response rates than previously treated patients.
CONCLUSIONS: In clinical practice, the efficacy and patient adherence to ustekinumab are excellent and even better to the data obtained in clinical trials. Clinical indicators of psoriasis severity: previous treatments with tumor necrosis factor α blockers agents and active treatment beside small increases in PASI determine a delayed maximal response.
J Drugs Dermatol. 2014;13(8):971-974.
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.
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.
Managing Occupational Irritant Contact Dermatitis Using a Two-Step Skincare Regimen Designed to Prevent Skin Damage and Support Skin Recovery
Erika C. von Grote PhD, Kiruthi Palaniswamy PharmD, and Matthew H. Meckfessel PhD| |
James Q. Del Rosso DO FAOCD| |
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.
J Drugs Dermatol. 2012;11(8):907-910.
75% Complete Response and 15% Partial Response to Extracorporeal Photopheresis Combined With Other Therapies in Resistant Early Stage Cutaneous T-Cell Lymphoma
Sila Seremet MD,a* Sunil Abhyankar MD,b* Tiffany J. Herd MD,b and Daniel Aires MDb| |
J Drugs Dermatol. 2016;15(10):1212-1216.
An Open-label Study of the Safety and Efficacy of Sertaconazole Nitrate in the Treatment of Seborrheic Dermatitis
Boni E. Elewski MD and Wendy C. Cantrell CRNP| |
Design: Single-center, open-label study.
Setting: One academic medical center.
Participants: Twenty adult male and female subjects aged 22 to 85 years (average, 56 years) with mild-to-severe seborrheic dermatitis of the face.
Measurements: The primary efficacy evaluation was the proportion of subjects with a score of 0 or 1 at the end of treatment (week 4) on the Investigator's Static Global Assessment scale. Secondary end points included percent change from baseline to week 4 in sum individual scores of erythema, scaling, induration, and pruritus at a preselected target lesion. Other end points included change in scores on Subject's Global Assessment scale and the Dermatology Life Quality Index.
Results: Success on the primary end point was achieved by 10 of 17 evaluable subjects (58.8%). Improvements in Investigator's Static Global Assessment score from baseline were statistically significant at each week. Significant improvements were also demonstrated in erythema, scaling, induration, and pruritus at week 4 compared to baseline. Improvement in Subject's Global Assessment scores compared to baseline were significant only at week 1 (P=0.031). Change in total mean SD Dermatology Life Quality Index scores from baseline to week 4 was 0.34 (± 0.62, P=0.039).
Conclusion: The results of this preliminary study support the efficacy and safety of sertaconazole nitrate cream, 2%, for the treatment of seborrheic dermatitis.
J Drugs Dermatol. 2011;10(8):898-902.
Andrea Chiricozzi MD,a Francesca Specchio MD,b Annunziata Dattola MD,b Monika Fida MD,c
Luca Bianchi MD,b and Sergio Chimenti MD,b
and Rosita Saraceno MDb
OBJECTIVE: The aim of this study is to detect electrophoretic abnormalities in psoriatic patients undergoing treatment with infliximab.
RESEARCH DESIGN AND METHODS: A retrospective study evaluating all charts from the clinic database of all patients treated with infliximab. The evaluation of serum protein profile is routinely performed in the clinical setting during biologic therapies. We reported the occurrence MGUS in infliximab-treated patients.
RESULTS: The study analysis included 141 charts. Overall, 23 patients showed a MGUS in their electrophoretic profile, though in 6 cases MGUS was detected at the baseline. Thereby, 17 cases (12.06% of the study population) developed MGUS during infliximab therapy.
CONCLUSIONS: Serum protein electrophoresis test represents a useful tool to detect and monitor any potentially harmful condition that could occur during treatment with a biologic agent. Particularly, it could be crucial for the detection of MGUS, which does not affect clinical response, and it does not represent a criteria to withdraw the treatment.
J Drugs Dermatol. 2016;15(2):134-138.
A Phase 2, Randomized, Controlled, Dose-Ranging Study Evaluating Crisaborole Topical Ointment, 0.5% and 2% in Adolescents With Mild to Moderate Atopic Dermatitis
Linda F. Stein Gold MD,a Lynda Spelman MBBS FACD,b Mary C. Spellman MD,c Matilda H. Hughes CCRA,d and Lee T. Zane MDd| |
METHODS: In this multicenter, randomized, double-blind, dose-ranging, phase 2 study, adolescent patients 12 to 17 years of age with mild to moderate AD and 2 distinct target AD lesions were randomized to once-daily (QD) or twice-daily (BID) treatment with crisaborole topical ointment. For each patient, 2 target lesions were randomized to receive 29 days of treatment with 0.5% or 2% crisaborole topical ointment. The primary endpoint was change from baseline in AD severity index (ADSI) score for each lesion. Exploratory efficacy endpoints and safety were also assessed.
RESULTS: A total of 86 patients were enrolled and received crisaborole topical ointment 0.5% or 2% QD (n=44) or BID (n=42). All dosing regimens produced dose-related improvements in ADSI as well as in all 5 component signs and symptoms of AD (erythema, excoriation, exudation, lichenification, and pruritus). The greatest improvements were consistently observed with crisaborole topical ointment, 2% applied BID. With this regimen, ADSI improved from baseline by 71%, and total or partial clearance of target lesions (ADSI ≤2) was achieved by 62% of patients after 29 days of treatment. Both doses of crisaborole topical ointment were well tolerated; mild application site reactions were the only treatment-related adverse events (QD, n=3; BID, n=1).
CONCLUSION: These results provide preliminary evidence of the efficacy and safety of crisaborole topical ointment, 2% applied topically BID in adolescents with mild to moderate AD.
J Drugs Dermatol. 2015;14(12):1394-1399.
Randomized, Placebo- and Active-Controlled Crossover Study of the Safety and Efficacy of THVD-102, a Fixed-dose Combination of Oxybutynin and Pilocarpine, in Subjects With Primary Focal Hyperhidrosis
David M. Pariser MD FACP FAAD,a Janakan Krishnaraja MD,b Thomas M. Tremblay RN,d R. Michael Rubison PhD,c Ted W. Love MD,d and Benjamin F. McGraw III PharmDd| |
Human Stem Cell-Derived Skin Progenitors Produce Alpha 2-HS Glycoprotein (Fetuin): A Revolutionary Cosmetic Ingredient
Gabriel Nistor MD,a Aleksandra J. Poole PhD,a Zoe Draelos MD,b Mary Lupo MD,c Thomas Tzikas MD,d Jerome H. Liu MD,e and Hans S. Keirstead PhDa| |
Human stem cells cultivated in balanced conditions were differentiated into skin lineage precursors, and shown to secrete large amounts of fetuin as well as multiple growth factors beneficial for human skin development and maintenance. The cell secretions were incorporated in two simple cosmetic formulations (serum and lotion) and investigated in an IRB-approved 12-week human trial that included 25 subjects in each group. Subjects were examined at 2, 4, 8, and 12 weeks by a dermatologist to evaluate safety, trans-epidermal water loss, wrinkles, firmness, radiance, texture, softness, and overall appearance. A sub-group of subjects from each group consented for biopsies for histological analyses.
Protein analyses in the cell secretions revealed a high concentration of the multifunctional alpha 2-HS glycoprotein (fetuin) along with a multitude of protein factors involved in the development and maintenance of healthy human skin. Clinical investigation demonstrated significant amelioration of the clinical signs of intrinsic and extrinsic skin aging, findings that were confirmed by significant changes in skin morphology, filaggrin, aquaporin 3, and collagen I content.
Our data strongly support our hypothesis that cosmetic application of stem cell-derived skin lineage precursor secretions containing fetuin and growth factors beneficial for human skin development and maintenance, positively influence intrinsic and extrinsic aging.
J Drugs Dermatol. 2016;15(5):583-598.
Transient Improvement in Chronic Psoriasis After Treatment of TNF-α Blocker Induced Disseminated M. Tuberculosis Infection
Philip R. Letada MD, Erin Hitchcock DO, Samuel L. Steele MD, Douglas Winstanley DO| |
J Drugs Dermatol. 2012;11(1):119-120.
Long-term Safety of Ketoconazole Foam, 2% in the Treatment of Seborrheic Dermatitis: Results of a Phase IV, Open-Label Study
Zoe D. Draelos MD a, Steven R. Feldman MD PhD b, Victoria Butners BSc c, and Alessandra B. Alió Saenz MD c| |
Objective: To assess the long-term safety of ketoconazole foam, 2%, twice daily, as required.
Methods: A 12-month, open-label, multicenter study. Subjects were evaluated at baseline and at weeks 4, 8, 16, 26, 39, and 52 (or early termination [ET]) for adverse events (AEs), serious AEs (SAEs), target lesion erythema, scaling, and pruritus, as well as Investigator's Static Global Assessment (ISGA) scores. Physical examinations were performed at baseline and at week 52/ET, and laboratory evaluations at baseline and at weeks 8, 26, and 52. A poststudy product-preference questionnaire was completed.
Results: Of 500 subjects enrolled, 498 were included in the safety population, and 363 completed the study. Overall, 57% of subjects reported ≥1 AE. Treatment-related AEs occurred in 14% of subjects, including application-site irritation (8%), application-site pain (4%), application-site pruritus (1%), and increased alanine aminotransferase (1%). Seven subjects were withdrawn because of treatment-related AEs. No SAEs (21 in 17 subjects) were considered to be related to study drug. Mean target lesion erythema, scaling, and pruritus scores improved by 2 units from baseline at all study visits; mean ISGA score improved by 1 unit at week 4 and by 2 units at subsequent visits. The foam vehicle was preferred by 67% of subjects.
Limitations: Evaluation of severity was limited to target lesion; no objective measure of adherence.
Conclusion: The long-term safety profile of ketoconazole foam, 2%, in subjects with seborrheic dermatitis was favorable and efficacy was maintained. This trial was registered at clinicaltrials.gov (NCT00703846).
J Drugs Dermatol. 2013;12(1):e1-e6.
Catherine N. Tchanque-Fossuo MD MS,a,b,* Derek Ho BS,a,b,* Sara E. Dahle DPM MPH,b,c Eugene Koo MS,a R. Rivkah Isseroff MD,a,b and Jared Jagdeo MD MSa,b,d| |
OBJECTIVE: To review published clinical experiences (case series and case reports) using LLLT for treatment of DFU, and provide evidence-based recommendations and future directions on the potential of LLLT as a therapeutic modality for DFU.
METHODS AND MATERIALS: On January 16, 2016 we searched the published literature using databases: PubMed, EMBASE, CINAHL, and Web of Science with key terms: “diabetic foot” AND (“low level laser therapy” OR “low level light therapy” OR “LLLT” OR “light emitting diode” OR “phototherapy” OR “laser”).
RESULTS: After screening of titles, abstracts and/or full-text, 7 original articles were suitable in our review. Our review contains 5 case series and 2 case reports that evaluated LLLT for treatment of DFU, and all reviewed studies have shown positive improvement of DFU using LLLT with no adverse events, albeit with limitations that may be minimized with future RCTs.
CONCLUSIONS: LLLT is an emerging and promising treatment modality to current alternatives that are costly and have shown limited success. Based upon the published evidence, we envision additional research may allow for stronger recommendation with LLLT for treatment of DFU.
J Drugs Dermatol. 2016;15(7):843-848.
Ross Brothers MD, Rawn E. Bosley MD, and Steven Daveluy MD| |
J Drugs Dermatol. 2014;13(8):960-966.
Elephantiasis nostras verrucosa is a rare disorder characterized by dermal fibrosis, hyperkeratotic, verrucous, and papillomatous le- sions that result from both chronic filarial and nonfilarial lymphedema. Various treatment options have been reported for this disease. We present a 64-year-old man with erythrodermic psoriasis and elephantiasis nostras verrucosa in whom the lesions were resolved almost completely after acitretin treatment.
J Drugs Dermatol. 2012;11(3):402-405.
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.
Pedram Ghasri BS,a Brad A. Yentzer MD,a Tushar S. Dabade MD,a Steven R. Feldman MD, PhDa,b,c| |
Background: Combination therapy is a common and appropriate treatment strategy for moderate-to-severe psoriasis, as it provides for enhanced efficacy and decreased toxicity compared to the use of a single agent. Acitretin is an effective oral retinoid for psoriasis that seems to find its greatest value when complemented by other topical and systemic treatments.
Objective: The primary aim of this study is to assess the use of acitretin in combination with other treatments for psoriasis.
Methods: We assessed the use of acitretin for the treatment of psoriasis using nationally representative survey data from the National Ambulatory Medical Care Survey (NAMCS).
Results: Among visits where acitretin was listed in the NAMCS, other psoriasis medications were co-prescribed in 62 percent of visits. The co-prescribed medications included topical corticosteroids (51%), calcipotriene (31%), biologics (6%), cyclosporine (5%), methotrexate (5%) and tazarotene (2%).
Conclusion: The use of acitretin in combination with other psoriasis treatments, particularly topical corticosteroids and calcipotriene, is a common practice. Acitretin is co-prescribed with the biologics, likely because of the relative lack of overlapping effects on immune function. The immune-sparing method of action of acitretin makes combination treatment with the systemic agents an attractive treatment option, especially in patients where further immunosuppression is unwarranted.
J Drugs Dermatol. 2011;10(8):876-880.
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| |
Ramsin Joseph Yadgar BS,a and Adam J. Friedman MDa,b| |
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
Acquired Epidermodysplasia Verruciformis and Its Relationship to Immunosuppressive Therapy: Report of a Case and Review of the Literature
Channa G. Ovits MD, Bijal D. Amin MD, Caroline Halverstam MD| |
J Drugs Dermatol. 2012;11(3):385-389.
Patricia Farris MD,a,b Jean Krutmann MD,h Yuan-Hong Li MD PhD,i
David McDaniel MD,c,d,e,f,g and Yevgeniy Krolj
J Drugs Dermatol. 2013;12(12):1389-1394.
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.
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.
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| |
Non-melanoma skin cancer most commonly affects Caucasians, and only rarely affects darker-skinned individuals. However, skin cancer in these groups is associated with greater morbidity and mortality. Ultraviolet radiation is the major etiologic factor in basal cell carcinoma (BCC) and likely plays a pivotal role in the development of other forms of skin cancer. Yet it is commonly thought among patients as well as physicians that darker pigmentation inherently affords complete protection from skin cancer development. This low index of suspicion results in delayed diagnoses and poorer outcomes. This review follows a detailed computer search that cross-matched the diagnosis of BCC with skin color type in a large commercial dermatopathology facility. The reported skin types, all Fitzpatrick skin types IV, V, and VI, and histories were confirmed. A predominance of pigmented BCCs was found in sun-exposed areas of these older individuals. Although less common in darker-skinned ethnic groups, BCC does occur and can pose significant morbidity. Thus, it is essential that dermatologists are familiar with the epidemiology and clinical presentation of all cutaneous malignancies in darker skin so that these patients are fully aware of risks as well as prevention of the disease.
J Drugs Dermatol. 2012;11(4):484-486.
Effectiveness of the "Mohs and Close" Technique in Increasing the Efficiency of a Mohs Micrographic Surgery
Dhwani Mehta MD,a Rebecca Jacobson MD,a Tonja Godsey,b Brian Adams MD MPH,a and Hugh Gloster Jr. MD a| |
Jamie Rosen BA, Angelo Landriscina BA, and Adam J. Friedman MD| |
Treatment of Actinic Keratoses With 5% Topical Imiquimod: A Multicenter Prospective Observational Study from 93 Austrian Office-based Dermatologists
Background: While randomized, controlled trials have generated information about the safety and efficacy of imiquimod 5% cream in
the treatment of actinic keratosis, still very little is known about the challenges and pitfalls of this therapy in the daily clinical routine.
Objective: To mirror the full picture of the actinic keratosis imiquimod routine therapy, ie, patient profile, in-therapy decisions, tolerability, and satisfaction.
Methods: The present observational, multicenter study included 463 patients from the offices of 93 non-hospital based Austrian dermatologists. Inclusion was solely based on the treatment decision of the dermatologist and the patient's will to participate. There were no specific interventions except suggested time points of visits with pre-defined documentation forms.
Results: The typical actinic keratosis patient was a male, aged 74 years, with a disease history of 5.7±5.3 years, who presented with 8.4±8.0 multiple pre-treated lesions at the face. More than 95% of the patients developed therapeutic skin responses (dominated by erythema and crusting), which led to a significant reduction of lesions from baseline to the end of the therapy. Notably, one-third of those patients prone to a second therapeutic course were submitted to another form of treatment. Post-imiquimod therapy comprised of antibiotic creams, topical steroids, and numerous emollients. Patients and dermatologists reported high satisfaction with the therapy including the cosmetic outcome.
Conclusion: Our data show the high need for experience at the dermatologist side and information at the patient side. Moreover, the method of treatment for imiquimod-related skin reactions definitively asks for standardization.
The study was registered at ClinicalTrials.gov (NCT01151956). Decision by ClinicalTrials.gov: Federal University Teaching Hospital, Feldkirch, Austria Protocol Record OBIMQ465-AK-08, Imiquimod and actinic keratoses: an observational study.
J Drugs Dermatol. 2012;11(5):574-578.
Matthew C. Matsunaga MDa and Paul S. Yamauchi MD PhDb| |
J Drugs Dermatol. 2016;15(8):925-929.
Christine S. Ahn BA,a Rosa Mateus MD,b Irfan Khan BA,c Babar K. Rao MDb,d| |
J Drugs Dermatol. 2013;12(12):1477-1480.
Pearl E. Grimes MD| |
OBJECTIVE: To assess the efficacy and safety of bimatoprost 0.03% alone and in combination with a topical steroid (mometasone) compared with mometasone alone in patients with nonsegmental vitiligo on nonfacial areas in a proof-of-concept study.
METHODS: This randomized, double-blind, controlled study was conducted over a 20-week treatment period. Patients were randomized to 1 of 3 treatment groups: bimatoprost monotherapy (n=11), bimatoprost plus mometasone (n=10), and mometasone plus placebo (n=11). The primary outcome was global response at week 20, based on an investigator’s assessment of improvement score of at least 5 (at least 50%–75% improvement from baseline) on an 8-point scale (0=worse; 7=cleared). Other outcomes included global response at other visits, response by anatomic site, change from baseline lesion severity (overall and by site), and safety.
RESULTS: Because of a lack of response observed for the primary end point, a post hoc analysis with a less stringent definition of response (score of ≥4 [25%–50% improvement]) was conducted. In this analysis, 46% of the bimatoprost plus mometasone group responded overall compared with 18% in the bimatoprost monotherapy group, and no patients in the mometasone plus placebo group. Greater response rates were observed in both bimatoprost groups compared with the mometasone plus placebo group starting at week 12. There were no differences among groups in signs and symptoms of irritation.
CONCLUSIONS: Bimatoprost alone or with mometasone provided greater repigmentation than treatment with mometasone alone. Larger studies that also assess facial lesions are warranted.
J Drugs Dermatol. 2016;15(6):703-710.
Purpose: To characterize trends in older adult psoriasis health care practices of US ambulatory physician offices from 1993 to 2009.
Methods: We used data from the National Ambulatory Medical Care Survey to assess demographics, specialties seen, and treatment in visits by older adult patients, 55 years of age and older.
Results: There were approximately 14.1 million outpatient visits for psoriasis among the older adult population during the study period. Older adult psoriasis patients were 52.4% female and 47.6% male. The most frequent older adult age group seen for psoriasis was the 55 to 64 year age group. Dermatologists saw 69.3% of patients, internists saw 14.5%, and general and family practitioners saw 11.6%. Topical corticosteroids were the most frequently prescribed medications. Dermatologists preferred clobetasol whereas non-dermatologists more commonly prescribed betamethasone. For both the 18 to 54 year age group and the 55 and older group, the leading 7 out of 10 medications prescribed were topical corticosteroids and calcipotriene. However, etanercept, coal tar, and fluocinolone were among the leading medications in the younger group but not in the 55 and older group.
Conclusions: Treatment approach for older adult psoriasis patients showed some differences among medical specialties and among the younger and older age groups. Further research specific to older adult psoriasis patients is needed to determine optimal treatment strategies for this patient population.
J Drugs Dermatol. 2012;11(8):957-962.
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| |
Nicholas A. Soter MD| |
Andrew Mamalis*,a,b Natallia Fiadorchanka MD*,c Lauren Adams MD,b Melissa Serravallo MD,c
Edward Heilman MD,c Daniel Siegel MD MS,c Neil Brody MD PhD,c and Jared Jagdeo MD MSa,b,c
J Drugs Dermatol. 2014;13(5):574-578.
Aesthetic Applications of Calcium Hydroxylapatite Volumizing Filler: An Evidence-Based Review and Discussion of Current Concepts: (Part 1 of 2)
Jason Emer MD FAADa and Hema Sundaram MD FAADb| |
METHODS: The first article of this two-part series provides an evidence-based review of study data pertaining to the mechanism of action and biocompatibility of CaHA filler, and its safety, efficacy and tolerability when used for aesthetic purposes. The review includes data from a number of prospective, controlled comparative studies, from several retrospective studies, and from a meta-analysis of reported complications from alloplastic filler procedures over a 20-year period. The study methodology and number of study subjects are sufficiently robust to provide a high Evidence Level for much of the data.
RESULTS: CaHA has good safety, efficacy and tolerability profiles that are comparable to those of hyaluronic acid (HA) fillers. It provides an initial, immediate volume replacement for up to 12 months followed by longer term correction due to biostimulation, resulting in collagenesis. Evidence Level II studies show longevity of 30 months or more after nasolabial fold implantation. Other studies demonstrate the appropriateness of CaHA filler for volume restoration to areas including the mid face, lower face and hands. CaHA is classified as an adjustable filler, whereas HA is fully reversible by hyaluronidase digestion. For this reason, and also because of CaHA's high viscosity and elasticity, evidence-based and experiential consensus suggests its avoidance in highly mobile areas (e.g. lips) or in anatomically unforgiving areas (e.g. the periocular region), where there may be increased incidence of nodules.
CONCLUSION: CaHA filler is safe, efficacious and well-tolerated when used appropriately. It is increasingly recognized that many patients require pan-facial volume restoration, and that many can benefit from combined treatments. Therefore, CaHA and HA fillers may be considered complementary rather than competitive to each other. The second article of this series offers a discussion of product characteristics, scientific principles and injection techniques to optimize treatment with CaHA filler, including special considerations for avoidance and management of complications.
J Drugs Dermatol. 2013;12(12):1345-1354.