Search Results for "Aging"
Michael K. Robinson PhD, Robert L. Binder PhD, Professor Christopher E.M. Griffiths| |
The Evolution of Injectable Poly-L-Lactic Acid From the Correction of HIV-Related Facial Lipoatrophy to Aging-Related Facial Contour Deficiencies
Cheryl Burgess MD| |
Ramsin Joseph Yadgar BS,a and Adam J. Friedman MDa,b| |
Joel Schlessinger MD,a Subhash Saxena PhD,b and Stuart Mohrb| |
J Drugs Dermatol. 2016;15(4):496-503.
Divya Sharma BS,a Mary-Margaret Kober MD,b and Whitney P. Bowe MDc| |
J Drugs Dermatol. 2016;15(1):9-12.
Sona Shah BS and Tina S. Alster MD| |
Review of Periorbital and Upper Face: Pertinent Anatomy, Aging, Injection Techniques, Prevention, and Management of Complications of Facial Fillers
Julie Woodward MD| |
Rosemarie Osborne PhD, Lisa A. Mullins, Bradley B. Jarrold| |
J Drugs Dermatol. 2011;10(2):125-132
Joseph R. Kaczvinsky, Jr. PhD and Pearl E. Grimes MD| |
Allison P. Weinkle BS,a Bryan Sofen MD,b and Jason Emer MDc| |
J Drugs Dermatol. 2015;14(11):1215-1228.
Composite Volumization of the Aging Face: Supra-Periosteal Space as the Foundation for Optimal Facial Rejuvenation
Z. Paul Lorenc MDa and Johnson C. Lee MDb| |
J Drugs Dermatol. 2016;15(9):1136-1141.
Macrene Alexiades MD PhD| |
OBJECTIVE: To clinically study the cosmetic effects of a novel jasmonate complex LR2412-Cx in the treatment of visible skin aging.
METHODS: LR2412-Cx was evaluated in a 15-subject open-label prospective clinical trial for the treatment of fine wrinkle appearance, texture, and pores. Subjects were evaluated by an investigator at baseline, day 1, day 3, and week 6 with the Alexiades comprehensive grading scale of skin aging, and introducing a novel pore-grading scale and subject quality of life assessments.
RESULTS: The mean (SEM) at baseline and at week 6 following twice-daily application were: for the appearance of wrinkles 2.91 (0.12) and 2.70 (0.10); for texture 2.91 (0.10) and 2.55 (0.10); and for pores 3.29 (0.08) and 2.46 (0.09), respectively. The differences in all 3 categories at all follow-up intervals were statistically significant (P<.005). The percentage improvement in investigator-assessed grades relative to baseline at day 1, day 3, and week 6 were: 2.3%, 4.9%, and 7.4% for the appearance of wrinkles, 5.7%, 9.4%, and 12.4% for texture, and 14.2%, 21.6% and 25.2% for pores, respectively. No significant untoward effects were reported.
CONCLUSION: Visionnaire LR2412-Cx is a novel jasmonate-containing compound that is safe and effective for the cosmetic treatment of fine wrinkle appearance, texture, and pores of the facial skin.
J Drugs Dermatol. 2016;15(2):209-215.
C. William Hanke MD MPH FACP, Kelley Pagliai Redbord MD
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.
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.
Dermatological Implications of Skeletal Aging: A Focus on Supraperiosteal Volumizationfor Perioral Rejuvenation
Danny Vleggaar MD, Rebecca Fitzgerald MD| |
A Novel, Multistep, Combination Facial Rejuvenation Procedure for Treatment of the Whole Face With IncobotulinumtoxinA, and Two Dermal Fillers- Calcium Hydroxylapatite and a Monophasic, Polydensified Hyaluronic Acid
Tatjana Pavicic MD,a Julius W. Few MD,b and Jürgen Huber-Vorländer MDc| |
J Drugs Dermatol. 2013;12(9):978-984.
12-month Effects of Stabilized Hyaluronic Acid Gel Compared With Saline for Rejuvenation of Aging Hands
Elena I. Gubanova MD,a,b Polina A. Starovatova MD,a,b Maria Y. Rodina MDc| |
Thirty women (mean age: 53 years) provided data up to M05. At M03, HA gel treatment improved hand skin condition in all patients versus D01, according to the GAIS; improvements were sustained to M12. Mean patient scores at M01–M03 were significantly higher for HA gel than for saline (P<0.05). Self-assessment questionnaire grades up to M03 were generally significantly better for HA gel versus saline (P<0.05); grades were maintained to M12. Statistically significant improvements with HA gel in hydration and elasticity was demonstrated at M03, compared with D01 and saline (P<0.05), and in terms of skin roughness versus D01. Maximum roughness (P<0.05) and waviness (P<0.01) were significantly improved versus saline.
All AEs were mild and anticipated, with no serious AEs.
Overall, HA gel injections were generally well tolerated and efficacious for rejuvenation of aging hands compared with saline. Sustained improvements at 12 months compared with baseline indicate that efficacy could be maintained long term.
J Drugs Dermatol. 2015;14(3):288-295.
Efficacy and Tolerability of a Skin Brightening/Anti-Aging Cosmeceutical Containing Retinol 0.5%, Niacinamide, Hexylresorcinol, and Resveratrol
Patricia Farris MD,a Joshua Zeichner MD,b and Diane Berson MDc| |
The use of this skin brightening/anti-aging cosmeceutical was found to provide statistically significant improvements in all efficacy endpoints by study end. Fine lines, radiance, and smoothness were significantly improved as early as week 2 (P<.001). By week 4, hyperpigmentation, overall skin clarity, evenness of skin tone, and wrinkles showed statistically significant improvement compared to baseline. Mild retinoid dermatitis including flaking and redness occurred early in the study as reflected by tolerability scores. By week 10, subjects reported no stinging, itching, dryness, or tingling.
The results of this open-label clinical study suggest that a topical cream containing retinol 0.5% in combination with niacinamide, resveratrol, and hexylresorcinol is efficacious and tolerable for skin brightening/anti-aging when used with a complementary skin care regimen including SPF 30 sun protection.
J Drugs Dermatol. 2016;15(7):863-868.
Susan Weinkle MD| |
A New Approach in Topical Hyaluronic Acid: Going Beyond Instant Benefits to Restore Epidermal HA Homeostasis
Debbie M. Palmer DO and Jennifer Silverman Kitchin MD| |
David E. Bank MD| |
Redaelli Alessio MD,a Berthold Rzany MD ScM,b Linda Eve MD,c Yann Grangier MD,d
Pedro Herranz MD,e Frédérique Olivier-Masveyraud MD,f and Danny Vleggaar MDg
J Drugs Dermatol. 2014;13(9):1057-1066.
Neil S. Sadick MD| |
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
A Firming Neck Cream Containing N-Acetyl Glucosamine Significantly Improves Signs of Aging on the Challenging Neck and Décolletage
Joel Schlessinger,a MD, Barbara Green RPh MS,b Brenda L. Edison BA,b Lynn Murphy MA,b and Yamini Sabherwal PhDb| |
OBJECTIVE: A clinical study was conducted to evaluate the efficacy and safety of the antiaging neck/décolletage cream over a 16-week treatment period.
METHOD: Caucasian women with moderate texture (including wrinkles, fine lines, laxity, and/or crepiness) on the neck and hyperpigmentation on the décolletage used the test cream for 16 weeks. At weeks 0, 8, 12 and 16, the dermatologist investigator graded neck texture, décolletage texture and décolletage pigmentation using a 0-5 scale, and irritation/tolerability using a 0-4 scale. Subjects were photographed and provided self-assessment of their aging parameters as well as product tolerability. Chromameter measurements were collected in triplicate on the chest at weeks 0, 8, and 16 to quantitatively and objectively assess pigmentation.
RESULTS: Forty-two women completed the study. All dermatologist-graded aging parameters were significantly improved at each time point, P<0.001. Chromameter measurements demonstrated significant improvements in brightness (L*) and redness (a*), P<0.05. Self-assessed aging parameters were significantly improved on the décolletage and neck, P<0.05. Digital photography demonstrated obvious antiaging effects including improved texture of neck and décolletage areas, reduced appearance of lines and wrinkles, reduced mottled hyperpigmentation, and a more youthful, firm appearance. The test cream was well-tolerated with no significant changes in irritation parameters throughout the study.
CONCLUSION: The antiaging neck/décolletage cream delivered significant firming and smoothing effects with reduced appearance of hyperpigmentation and can be considered an effective topical homecare treatment option for patients seeking rejuvenation of this challenging area.
J Drugs Dermatol. 2016;15(1):47-52.
Michael Kockaert, MD and Martino Neumann, MD, PhD| |
Evaluation of a Novel Anti-Aging Topical Formulation Containing Cycloastragenol, Growth Factors, Peptides, and Antioxidants
Robert A. Weiss MD FAAD FACPh and Margaret A. Weiss MD| |
METHODS: Twenty subjects were enrolled in a 12-week, open-label, patient-assessment study. Subjects used a gentle cleanser, cycloastragenol, growth factors, peptides, and antioxidants (Regeneration Booster™, Jan Marini Skin Research (San Jose, CA) and a broad spectrum SPF for the duration of the 12-week study. Assessments were taken at baseline, 2, 4, 8, and 12 weeks. All assessments were compared against baseline for statistical significance.
RESULTS: Eighteen of the twenty subjects completed the 12-week study. Improvement was significant after just 2 weeks of use for all measured categories except erythema and significant for all categories at 12 weeks. One hundred percent of study subjects noted improvement in at least 3 or more of the 8 assessed categories with an average improvement in 6.7 categories. Improvement response rate for individual categories ranged from 67% to 100% of study subjects. There were zero cases of sensitivity or irritation and product smell, feel and ease of application were rated “positive” by 100% of study subjects. Photographic improvement was most notable in texture and lines on the cheeks and eye area.
CONCLUSION: Regeneration Booster, when used as a stand–alone anti-aging solution, delivers rapid and significant reduction in the visible signs of aging. Subject satisfaction was extremely high and there were zero reported cases of sensitivity or irritation. Based on these observations, Regeneration Booster is a safe and effective topical product for individuals seeking significant improvement in the appearance of aging skin.
J Drugs Dermatol. 2014;13(9):1135-1139.
Sarah A. Malerich BS,a,b Amer H. Nassar MD,b Andrew S. Dorizas MD,b,d Neil S. Sadick MDb,c| |
J Drugs Dermatol. 2014;13(11):1331-1335.
An Open Label Clinical Trial of a Multi-Ingredient Anti-Aging Moisturizer Designed to Improve the Appearance of Facial Skin
James H. Herndon Jr. MD,a Lily Jiang PhD,a Tatiana Kononov BS MBA,b Theresa Fox BSb| |
J Drugs Dermatol. 2015;14(7):699-704.
Kendra Gail Bergstrom MD FAAD| |
J Drugs Dermatol. 2013;12(8):952-953.
Efficacy and Tolerability of Two Commercial Hyperpigmentation Kits in the Treatment of Facial Hyperpigmentation and Photo-Aging
Objective: This investigator-blinded, randomized trial was undertaken to compare two commercial hyperpigmentation systems (kits) used for the treatment of facial hyperpigmentation and photo-aging.
Methods: Female subjects with at least mild facial hyperpigmentation and photo-aging were randomized to treatment with either the four product SkinMedica (SKM) regimen or the 7-product Obagi (OMP) regimen. Evaluations were conducted at baseline, 4, 8, and 12 weeks. Subjects were evaluated by the blinded investigator for clinical efficacy and tolerability using grading scales. Standardized digital photographs were taken at baseline and week 12. Self-assessment questionnaires were completed at week 12. Thirty-five females (SKM=17, OMP=18) completed the 12-week study.
Results: Both treatment regimens showed a significant improvement at week 12 (compared to baseline) for Overall Hyperpigmentation, Global Photo-aging and Sallowness. At week 12, there was no significant difference between treatment groups in Global Response to Treatment. Tolerability was good for both regimens based on investigator assessments. Subject self-assessments showed no consistent differences in efficacy between the two regimens. Similarly, there was no significant difference in subject satisfaction or intent to continue use between the two regimens.
Conclusion: This clinical study demonstrated that both systems were equally effective at reducing hyperpigmentation and global photo-aging in females with mottled pigmentation and photodamaged facial skin.
J Drugs Dermatol. 2012;11(8):964-968.
William P. Werschler MD FAAD, Susan Weinkle MD FAAD| |
Macrene Alexiades MD PhD| |
J Drugs Dermatol. 2016;15(2):206-207.
Anne Chapas MD FAAD and Kendra Gail Bergstrom MD FAAD| |
Susan H.Weinkle MD and Jay P.Tiesman Phd| |
Zoe Diana Draelos MD,a Jwala Karnik MD,b and Gail Naughton PhDc| |
Clinical Evidence for the Activity of Tetrahydroxypropyl Ethylenediamine (THPE), a New Anti-Aging Active Cosmetic
Background/ Objectives: The cellular surface modification of superficial epidermal keratinocytes can induce immediate skin tensioning effects
and may improve signs of skin aging. Tetrahydroxypropyl ethylenediamine (THPE) is an active that has been described to induce keratinocytes'
morphological changes in vitro. We conducted an in vivo study to assess anti-aging clinical benefits of a THPE-containing product.
Methods: An eight-week double-blind, randomized intra-individual placebo controlled clinical study was performed to evaluate the clinical benefits of a 2.5% THPE-containing cream. This study included 41 Caucasian women who received the THPE cream product on one side of the face and a placebo cream on the other side daily. Evaluations were performed at baseline, 45 minutes after first application, week 4 and week 8 and included clinical examination and digital photography.
Results: The study demonstrated the immediate lifting effect of a 2.5% THPE-containing cream. Forty-five minutes after a single application on the face, as the skin surface smoothed out, light reflection was modified: healthy glow and radiance of the skin were significantly improved (respectively 22.9% and 40% of improvement) and skin yellowishness was reduced (7.1%). Notably, the THPE-treated side was significantly lifted, both immediately after product application (8.1%) and after 8 weeks of application (14%), compared to the placebo-treated side.
Conclusion: This clinical study demonstrated that the effect of a 2.5% THPE-containing cream on the keratinocytes cells leads to an immediate and long-term clinical improvement of the skin appearance (radiance and skin firmness, skin lifting) and can therefore be considered as a new anti-aging cosmetic active.
J Drugs Dermatol. 2011;10(10):1102-1105.
By Danny Vleggaar MD, and Ute Bauer MD| |
Application of a Topical Biomimetic Electrical Signaling Technology to Photo-Aging: A Randomized, Double-Blind, Placebo-Controlled Trial of a Galvanic Zinc-Copper Complex
Jeannette Chantalat MS MBA, Elizabeth Bruning BSC LLB, Ying Sun PhD, Jue-Chen Liu PhD| |
Objectives: To evaluate the efficacy and tolerability of a galvanic zinc-copper complex on photo-aging parameters in a randomized, double-blind, placebo-controlled clinical trial.
Materials and Methods: In this eight-week study, women (40-65 years) with mild to moderate photo-aging were randomized to use placebo or 1 of 3 galvanic zinc-copper complex compositions (gel and activating moisturizer). Efficacy evaluations included clinical grading, specialized clinical imaging, and subject self-assessments performed at baseline, 15-30 minutes after product application and after 1, 2, 4, and 8 weeks. Tolerability was based on adverse events and clinical grading of irritation. Significance was set at P≤0.05 versus baseline and between treatment groups.
Results: The study was completed by 124 women. Compositions containing the galvanic zinc-copper complex showed statistically significant clinical improvements versus placebo and baseline rapidly (15-30 min) after application and through week 8. Clinical grading showed significant improvement versus placebo in skin radiance and under-eye dark circles 15-30 minutes after first application with continued improvement through week 8, and in overall photo-damage, fine lines, lifted appearance of the eyes, and under-eye wrinkles starting after two weeks and continuing through week 8. Test compositions were well tolerated.
Conclusion: This galvanic zinc-copper complex provided rapid and lasting improvements versus placebo in photo-aged skin, supporting its use in topical anti-aging formulations.
J Drugs Dermatol. 2012;11(1):30-37.
Superior Efficacy of an Herbal-based Cosmeceutical Compared With Common Prescription and Cosmetic Antiaging Therapies
Carl R. Thornfeldt MDa and Ronald L. Rizer PhDb| |
MATERIALS AND METHODS: Six randomized split face, double blind, prospective, controlled clinical trials involving a total of 110 subjects compared a cosmeceutical blend of novel herbs in regimens consisting of one to three products to several common antiaging topical treatments. These comparative products include prescription tretinoin, physician strength idebenone, kinetin, polyhydroxy, lactic and glycolic acids in reversing signs of photoaging.
RESULTS:The novel cosmeceutical blend regimen showed superior efficacy and safety in all six trials.
DISCUSSION: These trials substantiate that herbs not used in common antiaging products effectively and safely mitigate and reverse photoaging signs and symptoms. The novel concept of treating photoaging and preventing its progression by repairing and optimizing the stratum corneum barrier, while reversing and inhibiting chronic cutaneous inflammation, has now been proven.
J Drugs Dermatol. 2016;15(2):218-223.
Skin Through the Ages: State-of-the-Art Options for the Topical Treatment of Acne, Photodamage, and Aging
A Novel, Volumizing Cosmetic Formulation Significantly Improves the Appearance of Target Glabellar Lines, Nasolabial Folds, and Crow's Feet in a Double-Blind, Vehicle-Controlled Clinical Trial
Patricia K. Farris MD,a Brenda L. Edison BA,b Ronni L. Weinkauf PhD,b Barbara A. Green RPh MSb| |
J Drugs Dermatol. 2014;13(1):41-46.
Magdalene Dohil MD, Leslie Baumann MD, Hema Sundaram MD, Jason Emer MD| |
Providing optimal patient outcomes continues to be a challenge in the treatment and management of dermatologic conditions. Most physicians and patients are interested in doing everything possible to optimize the treatment of their skin disease. This is especially important in treating patients with chronic disorders such as eczema, acne, psoriasis, rosacea, photodamage and the negative effects of aging. Physicians and patients often explore the therapeutic benefits of natural ingredients as alternative or complementary treatments to conventional methods. It is important that dermatologists remain up-to-date on the research and new advances in skin care products with natural ingredients.
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 1 category 1 CME Credit.
The Effect of a Combination of Recombinant EGF Cosmetic Serum and a Crosslinked Hyaluronic Acid Serum as Compared to a Fibroblast-Conditioned Media Serum on the Appearance of Aging Skin
Zoe Diana Draelos MD| |
J Drugs Dermatol. 2016;15(6):738-741.
Randomized, Double-Blind, Split-Face Study Evaluating Fractional Ablative Erbium:YAG Laser-Mediated Trans-Epidermal Delivery of Cosmetic Actives and a Novel Acoustic Pressure Wave Ultrasound Technology for the Treatment of Skin Aging, Melasma, and Acne Scars
Macrene Alexiades MD PhDa,b| |
AIM: Evaluate the safety and efficacy of a novel acoustic pressure wave ultrasound device following fractional ablative Er:YAG 2940-nm laser (FELR) and topical agents for rhytids, melasma, and acne scars.
STUDY DESIGN: Randomized, blinded, parallel group split-face side-by-side, controlled study evaluating FELR and topical anti-aging and anti-pigment agents to entire face succeeded by ultrasound to randomized side. Fifteen subjects were enrolled to three treatment arms:rhytids, melasma, and acne scars. Two monthly treatments were administered with 1, 3, and 6 month follow-up. Efficacy was assessed by Comprehensive Grading Scale of Rhytids, Laxity, and Photoaging by Investigator and two blinded physician evaluators. Subject assessments, digital photographs, and reflectance spectroscopic analyses were obtained.
RESULTS: Rhytid severity was reduced from a mean of 3.25 to 2.60 on the 4-point grading scale. Spectrophotometric analysis demonstrated increases in lightness (L*) and reductions in redness (a*) and pigment (b*), with greater improvements on the ultrasound side as compared to FELR and topicals alone. Moderate erythema post-treatment resolved in 7 days and no serious adverse events were observed.
CONCLUSION: In this randomized, paired split-face clinical study, FELR-facilitated TED of topical anti-aging actives with ultrasound treatment is safe and effective with improvement in rhytids, melasma, and acne scars. Statistically significant greater improvement in pigment levels was observed on the ultrasound side as compared to FELR-TED and topical agents alone.
J Drugs Dermatol. 2015;14(11):1191-1198.
Suzanne Bruce MD,a Jwala Karnik MD,b Laurence Dryer PhD,c and David Burkholder PhDd| |
METHODS: Female subjects age 35-65 with Fitzpatrick Skin Type I-IV and mild to moderate amounts of photodamage, fine lines, and wrinkles used Regenica® Replenishing Crème and Regenica® Renew SPF 15 for 3 months. At each visit, photos were taken of subjects while investigators completed skin grading assessments and subjects completed self-assessments. Investigator assessments included evaluation of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance, and translucence on a 5-point scale. Subjects’ self-assessments included assessment of fine lines and wrinkles, firmness, evenness of skin tone, brightness, resilience, clarity, and radiance. Changes from baseline were evaluated for each parameter and P values for changes from baseline to each study visit for investigator’s assessments and to end-of-study for self-assessments were calculated.
RESULTS: Eighteen of 21 enrolled female subjects completed the study. Three subjects chose to drop from the study. Statistically significant improvements in investigator assessments of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance and translucency compared to baseline were observed at weeks 4, 8, and 12 after initiating treatments. Progressive improvement was seen through the last study visit (visit 5, week 12). Similar statistically significant improvements in subjects’ self-assessments were seen comparing the first post-baseline visit (visit 2, week 2) to subsequent visits. 93.5 % subjects agreed (somewhat or strongly) with all of the positive subject assessment statements at week 12. Importantly, 100 % of subjects indicated at the end of the study that they would recommend the product to a friend and would want to purchase the product. No treatment-related adverse events were recorded during the study.
CONCLUSIONS: Regenica was safe and clinically effective in reducing anti-aging effects in this group of female subjects aged 35-65 years as measured by both investigator assessments and subjects’ self-assessments.
J Drugs Dermatol. 2014;13(9):1074-1081.
Skin Rejuvenation in Asian Skin: The Analysis of Clinical Effects and Basic Mechanisms of IntensePulsed Light
Yujie Feng, Junying Zhao, Michael H. Gold MD| |
Objectives: The objective of this clinical trial was to evaluate the effects and the mechanism of action of an IPL by comparing clinical photographs and biopsy results before and after treatment.
Methods: A total of 58 patients were treated using a new IPL device. Clinical photographs were taken before treatment and compared to those taken 3 weeks after the treatment. Also, 4 cases had pathological analyses of tissues that were stained by haematoxylin-eosin and Uana orcein. Immunohistology of human collagen of types 1 and 3 and quantitative analyses of elastin and collagen were performed by a poly-functional digital image light microscope; a transmission electron microscope was used for 2 of the cases to look for additional changes.
Results: After 3 treatments, 62.1% of the patients showed improvement in wrinkles and skin texture. Pigmentation improved in 84.6% of the patients, and a reduction in telangiectasis was seen in 81.25% of the patients. Pathological examination showed that both type 1 and type 3 collagens increased following treatment, but elastin content decreased; however, the elastin fibers were arranged more neatly. In the transmission electron microscope study, the amount of fibroblast activity increased, the fibroblasts were more active, and there were more collagen fibers neatly rearranged within the stroma.
Conclusion: Clinical and pathological studies demonstrated that the IPL was effective in improving wrinkles and skin texture. The mechanism of action may be through the increasing activity of the fibroblasts, hyperplasia of the fibroblasts, and rearrangement of both collagen and elastin within the stroma.
Pollution as a Risk Factor for the Development of Melasma and Other Skin Disorders of Facial Hyperpigmentation ‑ Is There a Case to Be Made?
Wendy E. Roberts MD FAAD| |
J Drugs Dermatol. 2015;14(4):337-341.
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.
An Experimental Double-Blind Irradiation Study of a Novel Topical Product (TPF 50) Compared to Other Topical Products With DNA Repair Enzymes, Antioxidants, and Growth Factors With Sunscreens: Implications for Preventing Skin Aging and Cancer
Enzo Emanuele MD PhD,a James M. Spencer MD MS,b and Martin Braun MDc| |
J Drugs Dermatol. 2014;13(3):309-314.
Evidence-Based Skincare: The Importance of Offering Moisturization, Relief, and Protection in Common Skin Disorders
Cheryl Burgess MD| |
Multi-Center Pilot Study to Evaluate the Safety Profile of High Energy Fractionated Radiofrequency With Insulated Microneedles to Multiple Levels of the Dermis
Joel L. Cohen MD,a Steven F.Weiner MD,b Jason N. Pozner MD,c Omar A. Ibrahimi MD PhD,d David B.Vasily MD,e E.Victor Ross MD,f and Zena Gabriel MDg| |
Topical Application of Preparations Containing DNA Repair Enzymes Prevents Ultraviolet-Induced Telomere Shortening and c-FOS Proto-Oncogene Hyperexpression in Human Skin: An Experimental Pilot Study
Enzo Emanuele MD,a Velimir Altabas MD,b Karmela Altabas MD,b and Enzo Berardesca MDc| |
J Drugs Dermatol. 2013;12(9):1017-1021.
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.
Neocollagenesis in Deep and Superficial Dermis by Combining Fractionated Q-Switched ND:YAG 1,064-nm With Topical Plant Stem Cell Extract and N-Acetyl Glucosamine: Open Case Series
Kavita Beri MDa and Sandy S. Milgraum MDb| |
METHOD: Six healthy females (Skin types III - V) were selected for the study with mean average age of 56 years +/- 11 years. The rhytides on the face and neck were assessed using a comprehensive grading scale. Patients were then divided into two groups, one received only laser treatment with the fractionated QSW 1,064 nm laser and the other group received combined treatment with the laser and topical. Patients were assessed again at 4 and 8 weeks.
RESULTS: We observed an enhanced anti-aging effect of the laser in the patients with combined treatment.
DISCUSSION: Understanding the effect of this novel laser therapy on human stem cells and investigating the basis of its synergistic effect with plant stem cell extract and NAG will lead us to better understand stem cell activity. Non-ablative tissue regeneration is the next step in providing optimal anti-aging treatments.
J Drugs Dermatol. 2015;14(11):1342-1346.
Pilot Evaluation of a Novel Topical Formulation Containing High Level, Cholesterol-Dominant, Physiological Lipids for Specific Targeting of Skin Barrier Deficits in Aging Skin
Hema Sundaram MD,a Ana Du BS,b Margarita Yatskayer MS,b Stephen Lynch PhD,b Yevgeniy Krol,c and Christian Oresajo PhDb| |
Generational Dermatology: Model for Prevention and Multi Decade Approach Toward the Evolving, Aging Patient
Wendy E. Roberts MD FAAD| |
J Drugs Dermatol. 2013;12(12):1396-1399.
One-year Topical Stabilized Retinol Treatment Improves Photodamaged Skin in a Double-blind, Vehicle-controlled Trial
Manpreeet Randhawa PhD,a Dianne Rossetti BSc,a James J. Leyden MD,b Jared Fantasia MSc,a
Joshua Zeichner MD,c Gabriela Oana Cula PhD,a Michael Southall PhD,a and Samantha Tucker-Samaras PhDa
OBJECTIVE: This study aimed to assess the efficacy and safety of 0.1% stabilized retinol on photodamaged skin during a one-year treatment.
METHODS: The investigation included two 52-week, double-blind, vehicle-controlled studies. In the main study, 62 subjects applied either a stabilized retinol formulation or its vehicle to the full face. A second exploratory study evaluated histological/histochemical markers in 12 subjects after 52 weeks of either retinol or vehicle use on contralateral dorsal forearms.
RESULTS: The retinol group showed significant photodamage improvement over vehicle at all timepoints during the study. After 52 weeks, retinol had improved crow’s feet fine lines by 44%, and mottled pigmentation by 84%, with over 50% of subjects showing +2 grades of improvement in many parameters. Additionally, at week 52, histochemical data confirmed the clinical results, showing increased expression of type I procollagen, hyaluronan, and Ki67 as compared to vehicle
CONCLUSION: This study confirms that a stabilized retinol (0.1%) formulation can significantly improve the signs of photoaging, and improvements in photodamage continue with prolonged use.
J Drugs Dermatol. 2015;14(3):271-276.
Emily C. Milam BA and Evan A. Rieder MD| |
J Drugs Dermatol. 2016;15(4):452-456.
A Randomized, Double-Blind, Controlled Comparative Trial of the Anti-Aging Properties of Non-Prescription Tri-Retinol 1.1% vs. Prescription Tretinoin 0.025%
Elizabeth T. Ho BS,a Nathan S. Trookman MD,b Brian R. Sperber MD PhD,b Ronald L. Rizer PhD,c Ralph Spindler PhD,d Sujatha Sonti PhD,a Vincent Gotz MS Pharm,e Rahul Mehta PhDa| |
J Drugs Dermatol. 2012;11(1):64-69.
David H. McDaniel MD FAAD,a Iltefat H. Hamzavi MD,b Joshua A. Zeichner MD,cSabrina G. Fabi MD FAAD FAACS,d Vivian W. Bucay MD,e Julie C. Harper MD,f Jody A. Comstock MD,g Elizabeth T. Makino BS CCRA MBA,h Rahul C. Mehta PhD,h and Virginia L. Vega PhDh| |
J Drugs Dermatol. 2015;14(suppl 7):s3-s11.
A High-Potency, Multimechanism Skin Care Regimen Provides SignificantAntiaging Effects: Results From a Double-Blind, Vehicle-Controlled Clinical Trial
Patricia K. Farris MD, Brenda L. Edison BA, Irina Brouda MA, Ronni L. Weinkauf PhD, andBarbara A. Green RPh MSPatricia K. Farris MD,a Brenda L. Edison BA,b Irina Brouda MA,b Ronni L. Weinkauf PhD,b and Barbara A. Green RPh MSb| |
J Drugs Dermatol 2012;11(12):1447-1454.
Leslie Baumann MD,a Deysi K. Duque MS,a and Michael J. Schirripa PhDb| |
OBJECTIVE: The purpose of this study was to assess the subjective efficacy, wearability, tolerance and overall preference of two professional vitamin C topical serums and sunscreens in Caucasian females using a split face method.
METHODS: A virtual split-face study of 39 Caucasian women compared two popular vitamin C and SPF product combinations – C-ESTA® Face Serum and Marini Physical Protectant SPF 45 (Jan Marini Skin, San Jose, CA; Products A) and CE Ferulic® and Physical Fusion UV Defense SPF 50 (Products B; SkinCeuticals Inc, Garland, TX). The products were assigned to each subject’s left or right side of the face, and subjects rated and compared products through 5 online surveys at baseline, 24 hours, days 3, 7, and 14.
RESULTS: Over 86% of the 35 subjects who completed the study preferred the smell and 83% preferred the feel and application of vitamin C Serum A over Serum B. Seventy-one percent of subjects preferred the feel and application of Sunscreen A over Sunscreen B. Results also showed a significant skin texture improvement and skin tone with Products A vs Product B. Products A trended higher for multiple additional categories.
CONCLUSIONS: Products A exhibited superior anti-aging benefits than Products B. Subjects preferred the smell, feel, and application of Products A and experienced significantly less irritation than Products B. Overall, Products A were preferred over Products B with subjects willing to pay more for Products A over Products B.
J Drugs Dermatol. 2014;13(10):1208-1213.
Improved Texture and Appearance of Human Facial Skin After Daily Topical Application of Barley Produced, Synthetic, Human-like Epidermal Growth Factor (EGF) Serum
A three month, open-label, single center study was conducted to determine whether a uniquely derived serum containing barley bioengineered, human-like epidermal growth factor protein could improve visible signs of photodamage and aging in facial skin. Twenty-nine females, aged 39 to 75 years, with mild to severe, fine and course rhytids, photodamage, and pigmentation were enrolled. Subjects then applied the treatment serum per the prescribed protocol twice-daily for 3 months, in addition to the use of a basic sunscreen and facial cleanser. In-person clinical evaluations and subject self-assessment questionnaires were administered at each follow up visit. In addition, clinical photography was completed at baseline, and each subsequent visit. Clinical evaluations showed statistically significant improvement in the appearance of fine lines and rhytids, skin texture, pore size, and various dyschromatic conditions apparent within the first month of use, and continuing improvement trends for the duration of the study. The treatment serum was well tolerated with minimal treatment-related complications reported throughout. Efficacy of this novel serum and treatment protocol resulted in meaningful improvements in photodamage and visible signs of aging.
J Drugs Dermatol. 2012;11(5):613-620.
An Open Label Clinical Trial to Evaluate the Efficacy and Tolerance of a Retinol and Vitamin C Facial Regimen in Women With Mild-to-Moderate Hyperpigmentation and Photodamaged Facial Skin
James H. Herndon Jr. MD,a Lily I. Jiang PhD,a Tatiana Kononov BS MBA,b and Theresa Fox BSb| |
J Drugs Dermatol. 2016;15(4):476-482.
Comparative Study of Professional vs Mass Market Topical Products for Treatment of Facial Photodamage
Hilary Reich MD,a,b Irmina Wallander BA,a Lacie Schulte MS BA,a Molly Goodier BS,a and Brian Zelickson MDa| |
OBJECTIVE: This split face study compares a mass market skincare regimen with a prescription skin care regimen for improvement in photo damaged skin.
METHODS: Twenty-seven subjects with moderate photo damaged facial skin were enrolled. Each subject was consented and assigned with the mass market anti-aging system (Treatment A) to one side of the face and the prescription anti-aging system (Treatment B or Treatment C) to the other side of the face. Treatment B contained 13 subjects whom did not use 0.025% Retinol cream. Treatment C contained 14 subjects who used a 0.025% Retinol Cream. Subjects had 4 visits over 12 weeks for digital photography and surveys. Photographs were evaluated by blinded physicians.
RESULTS: Physician objective analysis showed all three systems to have a statistically significant clinical improvement in photoaged skin seen in as little as 4 weeks of use. Participant’s surveys rated the mass market system higher than both of the professional systems for visible skin changes, ease of use, and likelihood to recommend to a friend. Twelve of twenty-seven subjects preferred the mass market system for overall improvement while twelve thought each system gave the same improvement.
CONCLUSION: This study demonstrates that a mass marketed skin care system can give similar clinical improvements in photo-aged skin as a professionally dispensed prescription system and the majority of participants preferred the mass-marketed system.
J Drugs Dermatol. 2016;15(1):37-44.
Alan D. Widgerow MBBCh MMed FCS FACS,a Sabrina G. Fabi MD FAAD FAACS,b
Roberta F. Palestine MD,c Alexander Rivkin MD,d Arisa Ortiz MD FAAD,b Vivian W. Bucay MD FAAD,e
Annie Chiu, MD,f Lina Naga MD,g Jason Emer MD,h and Paul E. Chasan MD FACSi
J Drugs Dermatol. 2016;15(Suppl 4):s63-s71.
Gary D. Monheit MD, Chad L. Prather MD| |
Excess Salt and Pepper Hair Treated with a Combination of Laser Hair Removal and Topical Eflornithine HCl
Laura K. Ganger MD, Iltefat H. Hamzavi MD| |
From DNA Repair to Proteome Protection: New Molecular Insights for Preventing Non-Melanoma Skin Cancers and Skin Aging
Enzo Emanuele MD PhD,a James M. Spencer MD MS,b and Martin Braun MDc| |
J Drugs Dermatol. 2014;13(3):274-281.
Hernan Pinto MDa and Luis G. Garrido MDb,c| |
J Drugs Dermatol. 2013;12(3):322-326.
Eileen L. Axibal MD,a Julia D. Kreger MD,a Michael E. Contreras MD,b and Joel L. Cohen MD FAADa,b,c| |
D. Vleggaar MD, R. Forte MD| |
Scott W. Dunbar MDa and David J. Goldberg MDa,b| |
J Drugs Dermatol. 2015;14(11):1229-1238.
Deborah S. Sarnoff MD FAAD FACPa,b and Robert H. Gotkin MD FACSb,c| |
OBJECTIVE: To demonstrate that a combination technique called ACELIFT – an acronym for the Augmentation of Collagen and Elastin using Lasers, Injectable neurotoxins, Fillers, and Topicals – in selected patients, is a viable, safe, and effective alternative to a facelift.
METHODS: Ten healthy women, ages 50 to 62 (mean age = 58), with cervical and facial stigmata of aging were enrolled in a prospective study conducted in the authors’ private practice. Patients underwent a two-step procedure; the first step was laser lipolysis of the submental and anterior cervical areas with a pulsed 1440nm Nd:YAG laser with a side-firing fiber (PrecisionTx, Cynosure, Westford, MA). Three months later, the patients were treated in a single session that combined injectable neurotoxin, fillers, and fractional (Fx) CO2 laser resurfacing delivered in a novel “hammock” distribution. After two weeks, following complete re-epithelialization, the patients were started on a topical regimen that included daily use of sunscreen and antioxidants and nightly use of retinoids and peptides. This regimen was continued for a period of six months when all patients returned for final evaluation.
RESULTS: Nine months following the initiation of treatment, all patients were evaluated by the following: Global Aesthetic Improvement Scale, cervicomental angle scale, physician, and subject evaluation. Clinical improvement was evident, and often marked, for all subjects. Both physician and subject satisfaction scores were high, indicating overall satisfaction with the procedure and the outcomes. Side-effects were mild and transient; there were no incidents of adverse scarring, thermal injuries, permanent nerve injury, or dyschromia, hematomas, seromas, or infection. Subjects were likely to recommend the procedure to a friend.
CONCLUSIONS: In properly selected patients, the ACELIFT proved to be a safe and effective, minimally invasive alternative to a facelift. There was little downtime and high patient satisfaction.
J Drugs Dermatol. 2014;13(9):1038-1046.
A Double-Blind, 12-Week Study to Evaluate the Antiaging Efficacy of a Cream Containing the NFκB Inhibitor 4-Hexyl-1, 3-Phenylenediol and Ascorbic Acid-2 Glucoside in Adult Females
Romain Roure MS,a Virginie Nollent Pharm.D,a Liliane Dayan MD,b Etienne Camel Pharm.D,c
Christiane Bertin MSa
J Drugs Dermatol. 2016;15(6):750-758.
Vic A. Narurkar MD,a Sabrina G. Fabi MD FAAD FAACS,b Vivian W. Bucay MD FAAD,c Ruth Tedaldi MD,d Jeanine B. Downie MD,e Joshua A. Zeichner MD,f Kimberly Butterwick MD,g Amy Taub MD,h Kuniko Kadoya PhD,i Elizabeth T. Makino BS MBA CCRA,i Rahul C. Mehta PhD,i and Virginia L. Vega PhDi| |
SkinMedica’s HA5 Rejuvenating Hydrator (SkinMedica Inc., an Allergan company, Irvine, CA) promotes restoration of endogenous epidermal HA homeostasis and provides instant smoothing and hydration of the skin. These dual benefits are accomplished through the combination of 2 breakthrough technologies: 1) a unique blend of actives powered by SkinMedica proprietary flower-derived stem cell extract that restores the endogenous production of HA; and 2) a proprietary mix of 5 HA forms that plump the skin, decreasing the appearance of fine lines/wrinkles.
Pre-clinical studies demonstrated that HA5 induces expression of key epidermal differentiation and barrier markers as well as epidermal HA synthases. A decrease expression of hyaluronidases was also observed upon HA5 application. Initial clinical studies showed that within 15 minutes of application, HA5 instantly improves the appearance of fine lines/wrinkles and skin hydration. Subjects that continue using HA5 (for 8 weeks) demonstrated significant improvements in fine lines/wrinkles, tactile roughness, and skin hydration. In summary, the blend of these 2 key technologies present in HA5 promotes restoration of endogenous epidermal HA while delivering instant smoothing effects.
J Drugs Dermatol. 2016;15(1 Suppl 2):s24-s37.
J Drugs Dermatol. 2011;10(5):494-498.
Terrence Keaney MD| |
J Drugs Dermatol. 2015;14(9):1036-1040.
Adam J. Luber BA, Shaheen H. Ensanyat BS, and Joshua A. Zeichner MD| |
J Drugs Dermatol. 2014;13(2):130-134.
J Drugs Dermatol. 2012;11(9):1053-1058.
Fractional, Nonablative Q-switched 1,064-nm Neodymium YAG Laser to Rejuvenate Photoaged Skin: A Pilot Case Series
Methods: Seven healthy female subjects (mean ±standard deviation age, 53.8 ± 10.0 years) with visible signs of facial and neck skin aging were treated with fractional, nonablative Q-switched 1,064-nm Nd:YAG laser device (Pixel QS Nd:YAG; Alma Lasers Ltd, Caesarea, Israel). Treated areas were the face, including the periorbital and perioral regions (particularly the upper lip), neck, and chest. Treatments consisted of 3 sessions at 2- to 4-week intervals. Follow-up was performed monthly following the final treatment. The Alexiades-Armenakas Comprehensive Grading Scale of Skin Aging was employed to assess efficacy. Pain ratings were recorded by 10-point visual assessment scoring.
Results: Employing the validated, quantitative grading scale for rhytides of the face and neck, a 0.29 grade improvement, or 11.3% improvement, over baseline grade was observed in the 7-subject cohort that completed follow-up following a mean of approximately 2 treatments at approximately 1-month follow-up. No pain and rapidly resolving minimal erythema were noted in all subjects during treatment.
Conclusion: The results of this pilot case series suggest that the treatment with the fractional, nonablative Q-switched 1,064-nm Nd:YAG laser device significantly improves superficial rhytides. With its outstanding safety, it seems to be particularly suitable for the treatment of sensitive areas, such as the periorbital region, lips, neck, and chest. The Q-switched Nd:YAG laser is a facile, safe, and fast treatment for aesthetic skin rejuvenation.
J Drugs Dermatol. 2012;11(11):1300-1304.
Stefanie Luebberding PhDa and Macrene Alexiades-Armenakas MD PhDa,b| |
In October 2013 the FDA approved for the first time ever an injectable dermal filler for the augmentation of age-related volume loss. This low-molecular-weight (LMW) 20mg/ml hyaluronic acid (HA) filler competes on the market with poly-L-lactic acid (PLLA) and calcium hydroxylapatite (CaHA), that have been used off-label for many years to restore age-related volume loss. The safety profile and efficacy of all three injectables has been intensively evaluated in innumerous clinical studies. However, each volume filler has its benefits and disadvantages, including usage, method of action and duration of effect that are reviewed in this article.
J Drugs Dermatol. 2013;12(12):1339-1344.
Currently, sunscreens play an important role in maintaining the health of the skin by providing “broad spectrum” protection against the harmful effects of UV radiation. However, this does not protect human skin from 94.2% of solar radiation (comprised of visible and IR lights), and nor does it prevent heat accumulation damage. Thus, none of the commercially-available sunscreens is able to block 100% of UV radiation.
Inspired by the need to provide patients with a more comprehensive solar protection, SkinMedica® has created Total Defense + Repair (TD+R), which combines broad spectrum UV protection with a unique blend of antioxidants (SOL-IR Advanced Antioxidant ComplexTM) that provide protection from IR radiation while promoting skin repair. These antioxidants are the product of scientific research and breakthrough technology, providing the next generation of multifunctional skin care products.
Whitney P. Bowe MD, Magdalene A. Dohil MD, Alan C. Logan ND, Andrew F. Alexis MD MPH| |
Jean Carruthers MD FRCSC FRC (OPHTH)a and Alastair Carruthers MD MRCP FRCPCb| |
J Drugs Dermatol. 2014;13(suppl 1):s7-s11.
J Drugs Dermatol. 2012;11(9):1046-1052.
Kimberly J. Butterwick, MD| |
In this study, thirty patients underwent concomitant submental tumescent liposuction and fat augmentation with the FAMI (fat autograft muscle injection) technique in order to assess short-term results and complications associated with these two relatively noninvasive procedures.
All patients had improvement in the cervicomental border, a smoother mandibular border, and a more proportioned chin following 3-5 days of swelling. Patients followed for 6 months to one year had long term retention of fat. There were no significant complications.
In this preliminary series, submental tumescent liposuction with FAMI provided enhanced aesthetic results with little downtime and minimal complications
Marina Landau MD| |
Rhytides, Laxity, and Photoaging Treated with a Combination of Radiofrequency, Diode Laser, and Pulsed Light and Assessed with a Comprehensive Grading Scale
Macrene Alexiades-Armenakas MD PhD| |
Neil S. Sadick, MD, FACP, FAACS| |
The major challenge facing the practicing dermatologist is how to employ this ever-growing array of products to improve patient care. Many questions are still unanswered, and the ultimate recommendation of which are optional products for the aging patient should be based upon peer-reviewed, scientifically based clinical research studies which prove the agent's therapeutic efficacy.
Optimizing Facial Rejuvenation Outcomes by Combining Poly-L-Lactic Acid, Hyaluronic Acid, Calcium Hydroxylapatite, and Neurotoxins: Two Case Studies
Z. Paul Lorenc MD FACSa and Elizabeth Daro-Kaftan PhDb| |
J Drugs Dermatol. 2014;13(2):191-195.
J Drugs Dermatol. 2012;11(2):220-224.
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.
The History Behind the Use of Injectable Poly-L-Lactic Acid for Facial and Nonfacial Volumization: The Positive Impact of Evolving Methodology
Danny Vleggaar MD,a Rebecca Fitzgerald MD,b and Z. Paul Lorenc MD FACSc| |
J Drugs Dermatol. 2014;13(suppl 4):s32-s34.
Joseph F. Fowler Jr. MD, Heather Woolery-Lloyd MD, Heidi Waldorf MD, Ritu Saini MD| |
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.
Methods:10 women aged 40 to 60 years were not preselected but were the first 10 women willing to undergo the study who fit the inclusion and exclusion criteria. Prior to receiving the filler, participants were asked to rate on a visual analog scale (VAS) from 1 to 6 how they felt about their appearance. Each woman received 1.0 cc of hyaluronic acid filler (Perlane, Medicis Corporation, Phoenix, AZ) into each cheek. Two weeks later they returned for photos and to complete the same VAS scale.
Results: Seven of ten women felt 0.5 to 2 points better about their appearance as measured by their VAS responses.
Conclusion:Cheek augmentation improves how a woman feels about her attractiveness.
J Drugs Dermatol. 2012;11(9):1077-1080.
Open-Label Study Evaluating the Anti-Aging Effects of a 3-Product, 2-Step Retinol-Rejuvenation System Following 3 Months of Treatment in Subjects With Photodamage
Suzanne Bruce MDa and Sylvia Barkovic BAb| |
Novel Eye Cream Containing a Mixture of Human Growth Factors and Cytokines for Periorbital Skin Rejuvenation
Mary L. Lupo MD, Joel L. Cohen MD, Marta I. Rendon MD| |
The Two Faces of Fractionated Photodynamic Therapy: Increasing Efficacy With Light Fractionation or Adjuvant Use of Fractional Laser Technology
Margit L.W. Juhasz MD,a,b Melissa K. Levin MD,a and Ellen S. Marmur MDa,c| |
Amir Moradi MD,a Azadeh Shirazi MD,b Veronica Pereza| |
Loss of volume in the temple can result in a gaunt, wasted appearance. Dermal filler augmentation of the temples can counteract volume loss and achieve a more balanced and youthful appearance. Although the temporal fossa is a critical area for volume restoration of the aging face, published information is limited. The authors retrospectively describe the treatment of 20 female patients who sought facial rejuvenation and received small gel particle hylauronic acid (SPG-HA) injections for temporal fossa augmentation. The authors discuss a rationale for their choice of dermal filler and provide a detailed, illustrated injection technique guide for restoring volume in the temporal fossa region with SPG-HA. There is a need for prospective, controlled studies investigating safety, efficacy and persistency of hyaluronic acid fillers in this area of the face.
J Drugs Dermatol. 2011;10(6):673-676.
Nonablative Skin Tightening with a Variable Depth Heating 1310-nm Wavelength Laser in Combination with Surface Cooling
Macrene Alexiades-Armenakas MD PhD| |
Ralph Fiore II DO, Sarah M. Coffman DO MSc, and Richard Miller DO| |
J Drugs Dermatol. 2013;12(3):353-357.
Mary P. Lupo MD FAAD| |
Hilary C. Reich MD,a Irmina Wallander BA,b Lacie Schulte BA,b Hilary Frickman BA,b
and Suzanne Flickenger BA,b Brian Zelickson MDb
J Drugs Dermatol. 2015;14(4):391-399.
Jean Carruthers MD, Steven R Cohen MD, John H. Joseph MD, Rhoda S. Narins MD, Mark Rubin MD| |
Evaluation of Efficacy and Tolerance of a Nighttime Topical Antioxidant Containing Resveratrol, Baicalin, and Vitamin E for Treatment of Mild to Moderately Photodamaged Skin
Patricia Farris MD,a Margarita Yatskayer MS,b Nannan Chen PhD,b Yevgeniy Krol BS,c Christian Oresajo PhDb| |
J Drugs Dermatol. 2014;13(12):1467-1472.
Aikaterini I. Liakou MD,a Michael J. Theodorakis MD,b Bodo C. Melnik MD PhD,c
Apostolos Pappas PhD,d and Christos C. Zouboulis MD PhDa
METHODS: Nutritional clinical studies in dermatology have been reviewed using the MedLine literature source and the terms "diet" or "nutrition" and "skin".
RESULTS & CONCLUSIONS: The data on the relationship between nutrition and skin are until now controversial and much more work is needed to be done to clarify possible etiological correlations.
J Drugs Dermatol. 2013;12(10):1104-1109.
Stabilized Hyaluronic Acid-based Gel of Non-animal Origin for Skin Rejuvenation: Face, Hand, and Decolletage
Meike Streker MD, Tilmann Reuther MD, Nils Krueger MD PhD, and Martina Kerscher MD| |
OBJECTIVE: To assess the efficacy and safety of a stabilized HA-based gel of non-animal origin manufactured using the patented NASHA® technology (Restylane® Vital Light, Q-Med AB, Uppsala, Sweden) administered using a pre-filled micropuncture injector device for rejuvenation of the skin.
METHODS: Three treatment sessions 4 weeks apart were performed on one side of the face, the dorsum of one of the hands and one side of the decolletage, leaving the other side untreated. Skin quality was assessed via blinded live evaluation and subject satisfaction by questionnaire. Aesthetic change was evaluated independently by the subject and a blinded evaluator. Subjects were followed up to week 36.
RESULTS: Thirty subjects aged 40–65 years were enrolled. Overall skin quality across all three treatment areas was judged to be improved on the treated side in over 80% of subjects throughout the study. Significant aesthetic improvements on the treated sides were observed at all visits, with the exception of the decolletage at week 36.
CONCLUSIONS: This was the first study that used a micropuncture injector device for injection of NASHA gel, and reveals that this is a promising treatment option for rejuvenation of the skin.
J Drugs Dermatol. 2013;12(9):990-994.
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.
Jonathan I. Silverberg MD PhD MPH,a,b,c Jared Jagdeo MD MS,a Mital Patel MD,a Daniel Siegel MD MS,a Neil Brody MD PhDa| |
Oxidative damage by reactive oxygen species (ROS) plays a major role in skin aging, carcinogenesis and inflammation. Little is known about the protective effects of green tea extract (GTE) on toxic ROS-induced skin death. We use an in vitro model of normal human skin fibroblasts (AG13145) to study the effects of green tea extract (GTE) on hydrogen peroxide (H2O2) induced necrosis. Cell morphology, numbers, apoptosis, necrosis, and ROS were assessed by epifluorescence microscopy and flow cytometry. This study demonstrates that GTE protected from H2O2-induced necrosis in a dose-dependent manner, with highest dose GTE (100 ng/mL) resulting in the most protection from necrosis, as assessed by improved cell morphology, increased cell numbers, and decreased necrosis. The protective effects of GTE on H2O2-induced necrosis appear to be mediated directly by decreasing intracellular ROS. The present study suggests that pretreatment with high doses of GTE could protect from toxic ROS-induced injury of skin in the clinical setting. However, additional studies are necessary to determine the clinical utility of GTE for decreasing skin cell ROS, necrosis and inflammation.
J Drugs Dermatol. 2011;10(10):1096-1101.
M. Shane Hamman MD,a Sabrina G. Fabi MD,b and Mitchel P. Goldman MDb
aDepartment of Dermatology, University of California San Diego, San Diego, CAbGoldman Butterwick Fitzpatrick Groff & Fabi, Cosmetic Laser Dermatology, San Diego, CA
Objective: To report and compare the efficacy and safety of HA used to treat tear trough deformities with two different injection techniques.
Materials and Methods: This is a retrospective, single-center study of 81 patients comparing the two injection techniques used for the treatment of tear trough deformities from 2003 to 2011. Hyaluronic acid was administered either in a single depot in the nasojugal groove and massaged into position or in multiple small aliquots along the inferior orbital rim and massaged into position. Patient satisfaction and the incidence of adverse reactions were evaluated.
Results: Of the 194 patients treated during the study period, 81 (42%) were successfully contacted. The overall patient satisfaction with the correction was similar for both techniques. Two patients treated with a single depot of HA were later given hyaluronidase, but otherwise, there was no statistically significant difference in the incidence and severity of side effects.
Conclusions: We describe and compare an alternative technique for the correction of tear trough deformity using a single deposition of HA in the nasojugal groove with favorable outcomes.
J Drugs Dermatol. 2012;11(12):e80-e84.
Derek Ho BSa and Jared Jagdeo MD MSa, b, c| |
OBJECTIVE: Evaluate the biological properties, including biochemical, biophysical and rheological, of this new 20 mg/ml HA dermal filler and discuss the importance of these properties in clinical applications.
METHODS AND MATERIALS: A systematic search of the computerized bibliographic databases Medline, Embase, Embal, Biosis, SciSearch, Pascal, HCAPlus, IPA, and Dissertation Abstracts with key term “Voluma.” Four articles on the biological properties of this new 20 mg/ ml HA dermal filler were suitable for inclusion in this review.
RESULTS: Biological analysis of elasticity and viscosity values of this new 20 mg/ml HA dermal filler demonstrated intermediate properties in three studies and high in one study compared to other HA dermal fillers. This 20 mg/ml HA dermal filler retained the highest elasticity and viscosity values at temperature of 37°C. Histology demonstrated that this 20 mg/ml HA dermal filler has an intermediate pattern of distribution within the superficial and deep reticular dermis.
CONCLUSION: This 20 mg/ml HA dermal filler demonstrated volumizing ability, and maintaining viscosity and free-flowing characteristics for easy injection, tissue lifting, and molding. We hope future research incorporates biological properties analysis of this HA dermal filler in clinical trials.
J Drugs Dermatol. 2015;14(1):50-54.
J Drugs Dermatol. 2012;11(11):1342-1346.
Novel Nonablative Radio-Frequency Rejuvenation Device Applied to the Neck and Jowls: Clinical Evaluation and 3-Dimensional Image Analysis
Lisa K. Chipps MD MS,a,b,c Jason Bentow MD,c Heidi B. Prather MD,d Jeffrey J. So MS PA-C,a
Jonathan M. Schouest BS,a and David M. Ozog MD,a,e Ronald L. Moy MDa,b
STUDY DESIGN: Forty-nine subjects received a total of two radio-frequency treatments to the face and neck one-month apart. The novel radio-frequency delivery device was used to heat the dermis between 41-43°C for five heat cycles. Primary outcome measures were clinical efficacy quantified by the Global Assessment Improvement Scale (GAIS) and a patient survey that assessed treatment satisfaction.
RESULTS: Assessments of 3D photographs revealed an overall improvement in 74% of study subjects. 85% of patients noted an overall improvement in the appearance of their skin. 81% of patients rated their post-treatment skin laxity as improved, 85% rated their skin smoothness as improved and 62% rated their skin brightness as improved.
CONCLUSION: Subjects in this study demonstrated an overall improvement in face and neck appearance with regard to skin tightening, wrinkles, and skin texture suggested by overall patient satisfaction (85%) and physician-rated GAIS improvement (74%). This study suggests that radiofrequency applied with a continuous thermal treatment device is a safe and efficacious way to improve the overall appearance of aging facial skin.
J Drugs Dermatol. 2013;12(11):1215-1218.
Frank Dreher PhD| |
J Drugs Dermatol. 2016;15(4):457-464.
2016 Arte Poster Competition First Place Winner: Circadian Rhythm and UV-Induced Skin Damage: An In Vivo Study
Linna Guan BS,a,* Amanda Suggs MD,a,* Sayeeda Ahsanuddin BS,a Madeline Tarrillion DO,a Jacqueline Selph MD,a Minh Lam PhD,a and Elma Baron MDa,b,c| |
J Drugs Dermatol. 2016;15(9):1124-1130.
An Open Label Clinical Trial of a Peptide Treatment Serum and Supporting Regimen Designed to Improve the Appearance of Aging Facial Skin
Zoe Diana Draelos MD,a Tatiana Kononov BS MBA,b and Theresa Fox BSb| |
J Drugs Dermatol. 2016;15(9):1100-1106.
Human Growth Factor and Cytokine Skin Cream for Facial Skin Rejuvenation as Assessed by 3D in Vivo Optical Skin Imaging
Michael H. Gold MD, Mitchel P. Goldman MD, Julie Biron| |
Reduced Appearance of Under-eye Bags With Twice-daily Application of Epidermal Growth Factor (EGF) Serum: A Pilot Study
Rachel Seidel BAa and Ronald L. Moy MD FAADa,b| |
OBJECTIVE: We studied the ability of a topical serum containing epidermal growth factor (EGF) to minimize the appearance of under-eye bags.
METHODS: A single-center clinical trial was performed on eighteen volunteer male and female patients with under-eye bags. Subjects applied EGF serum to the infraorbital area twice daily for 12 weeks. At each visit, subjects were evaluated using clinical photography and written self-assessment. A grade on the Merz Infraorbital Hollowness Scale was also given and two independent, blind investigators assigned an Investigator’s Global Assessment (IGA) score. At the trial’s end, patients shared their final evaluation and perception of results with a questionnaire.
RESULTS: Sixteen subjects completed the trial. The final average Merz grade was 1.63 (SEM = .273), statistically significantly lower than the mean baseline average of 2.06 (SEM = .232) (P = .0019). A reduction in average IGA score was also significant (P < .0001). Average initial IGA was 2.75 (SEM = .270) and average final IGA was 2.00 (SEM = .310). All but two subjects reported improvement at the final visit. Improvement was quantified as 76-100% by two subjects, 50-75% by three subjects, and 25-49% by nine subjects. Eleven subjects classified their under-eye bags as milder at the end of the trial compared to the first visit. Seven subjects reported greater satisfaction with their overall facial appearance. Of the subjects who had used other topical treatments in the past, two reported the serum to be “significantly better” and four said it was “better” in treating their under-eye bags.
CONCLUSION: Our results offer evidence that topical EGF can reduce the appearance of under-eye bags.
J Drugs Dermatol. 2015;14(4):405-410.
Evaluation of the Safety and Efficacy of a Novel 1440nm Nd:YAG Laser for Neck Contouring and Skin Tightening Without Liposuction
Deborah S. Sarnoff MD FAAD FACP| |
OBJECTIVE: To test the safety and efficacy of a pulsed 1440nm Nd:YAG wavelength and side-firing fiber for the treatment of subcutaneous fat and skin laxity associated with the aging neck.
METHODS: Twenty-four subjects aged 40 to 65 years underwent laser lipolysis of the submental and anterior cervical areas. An average of 1205J per 5x5cm square was delivered, with a maximum internal temperature setting of 47 degrees C. Cervicomental Angle Score (CAS), Global Aesthetic Improvement Scale (GAIS), subject and investigator satisfaction, and safety were assessed.
RESULTS: At six months post-treatment, 79% of subjects had a significant improvement in the CAS (P<.001) and 79% demonstrated an improvement on the GAIS. Clinical improvement was marked and evident for all but one subject, with physician and patient satisfaction scores indicating overall satisfaction with the procedure and outcomes. Adverse events were mild and transient with no incidence of burns, seromas, hematomas, infection, or nerve damage.
CONCLUSION: The 1440nm Nd:YAG device with the side-firing fiber was safe and effective for the treatment of subcutaneous fat and skin laxity in the neck. This device offers an alternative to selected individuals aged 40 and over who do not wish to undergo rhytidectomy.
J Drugs Dermatol. 2013;12(12):1382-1388.
Topical Human Epidermal Growth Factor in the Treatment of Senile Purpura and the Prevention of Dermatoporosis
Braden McKnight BS,a Rachel Seidel BA,b and Ron Moy MDa| |
OBJECTIVE: To examine the effects of topically human epidermal growth factor on the clinical presence of senile purpura and its effect on skin thickness as measured via cutaneous ultrasound.
METHODS: Six subjects applied human epidermal growth factor morning and night for six weeks. Clinical outcomes were evaluated by comparing initial clinical photos to 6-week photos and performing a blinded investigator’s global assessment (IGA). Skin thickness was evaluated via cutaneous ultrasound measurement.
RESULTS: Ultrasound measurements indicated a mean skin thickening of 195.2 ± 35.7um (SEM) over 6 weeks. The average number of purpuric lesions decreased from 15 ± 4.6 (SEM) to 2.3 ± 0.7 (SEM) over that same period.
CONCLUSION: Senile purpura presents itself as a cosmetic disturbance posing significant psychological distress and serves as a marker of the severity of skin thinning. In this study, we demonstrate that topical h-EGF diminishes the appearance of senile purpura by thickening skin and may help prevent the development of late stage dermatoporosis.
J Drugs Dermatol. 2015;14(10):1147-1150.
A Proposed Method for Upper Eyelid and Infrabrow Tightening Using a Transcutaneous Temperature Controlled Radiofrequency Device With Opaque Plastic Eye Shields
Douglas J. Key MD and Lauren Boudreaux DO| |
Wendy E. Roberts MD| |
J Drugs Dermatol. 2014;13(4):472-482.
A Split-Face Assessment of the Synergistic Potential of Sequential Q-Switched Nd:YAG Laser and 1565 nm Fractional Nonablative Laser Treatment for Facial Rejuvenation in Fitzpatrick Skin Type II-V Patients
Girish Munavalli MD MHS FAAD FACMS| |
Efficacy and Safety of IncobotulinumtoxinA for the Treatment of Platysmal Bands of the Aging Neck: An Open-Label, Prospective Pilot Study
Elena I. Gubanova MD,a Olga S. Panova MD,b Elena A. Sanchez MD,b
Maria Y. Rodina MD,a and Polina A. Starovatovaa
OBJECTIVE: To determine the efficacy and safety of incobotulinumtoxinA for the treatment of platysmal bands.
METHODS: Women, 35–65 years of age, with platysmal bands scoring 2 or 3 on the validated 5-point Merz dynamic platysmal bands scale received a total of 60 U incobotulinumtoxinA divided between four platysmal bands (20 U in both medial bands and 10 U in both lateral bands). Investigator assessments according to the 5-point scale were made at baseline and from standardized clinical photographs taken at follow-up visits 14±2, 56±7 and 84±7 days after treatment. The global aesthetic improvement scale (GAIS) and a novel questionnaire were used to assess subject treatment satisfaction. Adverse events were recorded.
RESULTS: Twenty-five women (mean age 51.8 years) were included in the study. With a responder defined as a subject with at least a 1-point improvement from baseline on the dynamic platysmal bands scale, the response rate at maximum contraction was 100% at Day 14 as assessed by the investigator. By the same definition, a high response rate (96%) was maintained at maximum contraction at Day 84. Subjects reported that, at Day 84, 86.3% of the maximal effect (defined as the effect on Day 14) persisted. Subject-reported satisfaction was high, as indicated by the self-assessment on the GAIS and results from the subject satisfaction questionnaire. Treatment- related adverse events were mild and reversible.
CONCLUSION: IncobotulinumtoxinA is an effective, well-tolerated treatment for platysmal bands, with a high percentage of the treatment effect maintained at 3 months after treatment. Investigator and subject assessments both indicated high levels of treatment satisfaction.
J Drugs Dermatol. 2013;12(12):1461-1466.
Two-Treatment Protocol for Skin Laxity Using 90-Watt Dynamic Monopolar Radiofrequency Device With Real-Time Impedance Intelligence Monitoring
David McDaniel MD,a Robert Weiss MD,b Margaret Weiss MD,b Chris Mazur BS,a and Charmaine Griffin CCRPa| |
OBJECTIVE: The objective was to validate effectiveness of a modified treatment protocol for a unique monopolar radiofrequency device, which has been engineered with greater power and self-monitoring circuitry.
METHODS: Twenty-four female subjects received bilateral monopolar radiofrequency treatments to the mid and lower face from the sub malar region to the submentum. Subjects completed 1 and 3 month follow ups with digital imaging. Skin biopsies (on 4 subjects) and ultrasound measurements (on 12 subjects) were completed.
RESULTS: Assessments demonstrated a reduction in skin laxity of 35%, a reduction in fine lines/wrinkles of 42%, and a reduction in the appearance of global photodamage of 33%. Expert photograding demonstrated 92% of subjects showing at least a mild improvement in skin laxity at three months post treatment. 50MHz ultrasound measurements in 12 subjects showed an increase of 19% in skin density. Histology showed a marked increase in dermal collagen and elastin fibers in two subjects who demonstrated a clinically noticeable reduction in skin laxity and minimal changes in two subjects who demonstrated minimal clinical improvements. There were no significant adverse events reported.
CONCLUSION: This modified radiofrequency device and treatment protocol was well tolerated and produced improvements in the appearance of skin laxity and overall anti-aging effects in the majority of subjects. Objective measurements including ultrasound and histology help explain the clinical outcome.
J Drugs Dermatol. 2014;13(9):1112-1117.
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.
Pilot Comparative Study of the Topical Action of a Novel, Crosslinked Resilient Hyaluronic Acid on Skin Hydration and Barrier Function in a Dynamic, Three-Dimensional Human Explant Model
Hema Sundaram MD,a Nicolas Mackiewicz PhD,b Emeline Burton MSc,b Laurent Peno-Mazzarino BSc,c Elian Lati PhD,c and Stéphane Meunier PhDb| |
METHODS: Standardized doses of each HA product were applied daily for 9 days to human skin explant surfaces. Untreated explants served as controls. Water content of the stratum corneum and entire epidermis was analyzed by Raman spectroscopy. Transepidermal water loss (TEWL) was measured to assess skin barrier function. Explant morphology and microrelief were evaluated by optical and scanning electron microscopy.
RESULTS: Crosslinked RHA achieved a significant increase in epidermal water content (7.6%) over the control. Spectral cartography confirmed a higher epidermal water content with RHA than with HMW HA or LMW HA. TEWL was reduced by 27.8% with RHA, and by 15.6% with HMW HA, but increased by 55.5% with LMW HA. Cutaneous microrelief improved with RHA. Corneocyte cohesion improved with RHA and HMW HA.
CONCLUSIONS: This comparative, multimodal study demonstrated greater benefits of topical crosslinked RHA over linear HMW HA or LMW HA in reducing TEWL, retaining and redistributing water within the epidermis, maintaining skin integrity, and improving skin barrier structure and function. RHA was a more efficacious humectant than LMW HA, and a more efficacious occlusive moisturizer than HMW HA. These integrative epidermal repair activities are of significant value for addressing primary deficits of aging skin, improving tolerance to retinoids and other topical agents, and optimizing procedural outcomes. A combination of topical and injectable HA provides an elegant model of synergistic, multi-level skin restoration.
J Drugs Dermatol. 2016;15(4):434-441.
A Review of Clinical Trials Conducted With Oral, Multicomponent Dietary Supplements for Improving Photoaged Skin
Jay Birnbaum PhD,a Anne Le Moigne,b Lisa Dispensa MS RD,c and Larry Buchner BAd| |
J Drugs Dermatol. 2015;14(12):1453-1461.
Macrene Alexiades-Armenakas MD PhD| |
Macrene Alexiades-Armenakas MD PhD holds three Harvard degrees, an extensive 20+ year background in research, and runs clinical and laboratory studies focusing on anti-aging skin care, acne, skin cancer, and lasers. Her clinical practice on Park Avenue is focused on dermatology and laser surgery. Dr. Alexiades holds a BA from Harvard University, where she was elected to Phi Beta Kappa and awarded the Fay Prize, the highest undergraduate honor, an MD from Harvard Medical School, and a PhD in Genetics from Harvard University. She is dual certified in medicine, surgery, and dermatology in the EU as well as the US.
Jeremy B. Green MD a board-certified dermatologist, graduated cum laude with a bachelor's degree from Princeton University. He completed his medical education at the Northwestern University Feinberg School of Medicine and the University of Miami Miller School of Medicine where he graduated with Alpha Omega Alpha (AOA) honors. He trained at the University of Miami Department of Dermatology where he served as its chief resident. Dr. Green currently practices with Dr. Brandt Dermatology Associates in Coral Gables, Florida, where they have chosen to make the Excel V laser an integral part of their practice.
Neil Sadick MD FAAD FAACS FACP FACPh a native New York City resident, completed his medical school training at SUNY Upstate. His residency, in internal medicine, was completed at Cornell/North Shore University/Memorial Sloan Kettering Medical Center. Dr. Sadick then went on to train in dermatology at New York Hospital, during which time he served as chief resident until the completion of his training in 1983. Dr. Sadick holds five board certifications in internal medicine, dermatology, cosmetic surgery, hair restoration surgery, and phlebology. Dr. Sadick is the medical director and owner of Sadick Aesthetic Surgery and Dermatology with locations on Park Avenue in New York City and Great Neck, Long Island.
David B. Vasily MD FAAD received a Bachelor of Science in Biology degree, with honors from Moravian College, magna cum laude. He obtained his medical degree from SUNY at Buffalo School of Medicine. Following his internship at Allentown Hospital, he completed a dermatology residency at Geisinger Medical Center in Danville, Pennsylvania. Dr. Vasily is board-certified by the American Board of Dermatology and a Fellow of the American Academy of Dermatology. He is a well-known dermatologist, who has also served as founder and president of Lehigh Valley Dermatology Associates, Ltd. since its inception over 30 years ago.
Michele Gasiorowski MD| |
Evidence-Based Skincare: The Importance of Offering Moisturization, Relief, and Protection in Common Skin Disorders
Leon H. Kircik MD| |
C. William Hanke MD MPH FACP| |
Anne Goldsberry MD MBA,a Alan Dinner PhD, and C. William Hanke MD MPHa| |
J Drugs Dermatol. 2014;13(3):306-307.
Macrene Alexiades-Armenakas MD PhD| |
The Need for Consensus Recommendations on the Use of Injectable Poly-L-LacticAcid for Facial and Nonfacial Volumization
Danny Vleggaar MD, Rebecca Fitzgerald MD, and Z. Paul Lorenc MD FACS| |
Prospective, Multicenter Study to Determine the Safety and Efficacy of a Unique Radiofrequency Device for Moderate to Severe Hand Wrinkles
Janelle M. Vega MDa, Vivian W. Bucay MDb, and Flor A. Mayoral MDa| |
J Drugs Dermatol. 2013;12(1):24-26.
An Evaluation of the Benefits of a Topical Treatment in the Improvement of Photodamaged Hands With Age Spots, Freckles, and/or Discolorations
Michael H. Gold MDa,b and Conor Gallagher PhDc| |
OBJECTIVE: To evaluate the efficacy of a topically applied cream formulated with an alpha-hydroxy acid, depigmenting agents, and antioxidants to improve the appearance of characteristics associated with photodamaged hands.
METHODS: This was a single-site, open-label study of a proprietary topical treatment (Vivité Vibrance Décolleté, Allergan, Inc.) in adult female subjects with moderate-to-severe photoaging of the hands. The treatment was administered to the hands twice daily over an 8-week period. Treatment efficacy was assessed at baseline and weeks 4 and 8 using the Investigator Global Assessment (IGA) score based on the percentage coverage and color depth of photodamaged areas. The severity of age spots, freckles, and hand skin discoloration were also assessed; digital and ultraviolet photography of the hands was performed. Subject-reported assessments of treatment efficacy were evaluated using a questionnaire administered at week 8. Statistical significance was defined with an α set at P≤.05.
RESULTS: Thirty-five subjects were enrolled with a mean age of 55.6 years; 33 subjects completed the study. The IGA of the appearance of hand photodamage improved from a mean (standard deviation) score of 5.0 (0.8) at baseline to 3.1 (1.5) and 2.6 (1.3) at weeks 4 and 8, respectively (1=mild; 9=severe). Based on expert-grader evaluation, subjects demonstrated statistically significant improvements from baseline in IGA at weeks 4 and 8 in age spots and freckling at weeks 4 and 8, (P<.0003) and in skin discolorations at week 8 (P<.05). The majority of subjects reported that they perceived improvements in each of the 9 parameters associated with skin appearance. No adverse events were reported.
CONCLUSIONS: The appearance of age-related hand pigmentation characteristics were significantly improved at 4 and 8 weeks of treatment. Subjects reported post-treatment improvements in other characteristics associated with healthy skin.
J Drugs Dermatol. 2013;12(12):1468-1472.
Efficacy and Safety of Incobotulinumtoxin A for the Correction of Glabellar Lines Among Patients With Skin Types IV to VI
Brooke A. Jackson MDa and Mark R. Vogel MAb| |
OBJECTIVE: To investigate the efficacy and safety of incobotulinumtoxin A [Xeomin® (XEO)] for the correction of glabellar lines among non-Caucasian patients with Fitzpatrick skin types IV to VI.
METHODS: This open-label, single-center, post-marketing study treated 29 patients with Fitzpatrick skin types IV to VI with moderate to severe glabellar frown lines. Evaluation at day 0 included standardized photographs and patient and investigator assessments. Post evaluation, XEO was administered at 5 intramuscular injection sites with equal aliquots of 4 units per 0.1 mL. Photographs and assessments were repeated at days 30 and 90.
RESULTS: Response to treatment was defined as a 1 or more point improvement in patient and investigator assessments. At day 30, 100% (n = 29; 95 C.I. 0.87, 1.00; P< .001) responded to treatment. At day 90, 69% (n=20; 95% C.I. 0.52, 0.83; P= .42) responded to treatment. The safety profile was similar to previously reported trials with BoNTA.
CONCLUSION: The efficacy and safety of XEO among patients with skin types IV to VI is similar to that among persons with fairer skin.
J Drugs Dermatol. 2015;14(4):350-353.
Danny Vleggaar MD,a Rebecca Fitzgerald MD,b and Z. Paul Lorenc MD FACSc| |
J Drugs Dermatol. 2014;13(suppl 4):s40-s43.
Assessment of the Safety and Efficacy of Topical Copper Chlorophyllin in Women With Photodamaged Facial Skin
Monya L. Sigler PhD, and Thomas J. Stephens PhD| |
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 women with mild-moderate fine lines and wrinkles in the periocular areas and facial solar lentigenes over a course of 8 weeks.
METHODS: Subjects were supplied with the test product, a topical gel containing chlorophyllin complex salts (0.066%), with directions to apply a pea-sized amount to the periocular areas, cheeks and nose every morning and evening. Clinical assessments were performed at screening/baseline and at week 8. Standardized digital photographs were taken and self-assessment questionnaires were conducted.
RESULTS: Ten subjects completed the 8-week study. All clinical efficacy parameters showed statistically significant improvements over baseline at week 8. 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 photodamage and solar lentigenes when used for 8 weeks.
J Drugs Dermatol. 2015;14(4):401-404.
Whitney P. Bowe MD| |
Safety and Effectiveness of Hyaluronic Acid Injectable Gel in Correcting Moderate Nasolabial Folds in Chinese Subjects
Yan Wu MD PhD,a Jinhua Xu PhD,b Yi Jia MD MSc PhD,c and Diane K. Murphy MBAd| |
OBJECTIVE: To evaluate the safety and effectiveness of Juvéderm Ultra vs Restylane® for the correction of moderate NLFs in Chinese subjects.
METHODS: In this double-blind randomized study, adult Chinese subjects with moderate NLFs received Juvéderm Ultra (24 mg/mL) in 1 NLF and Restylane injectable gel (20 mg/mL) in the other NLF. NLFs were evaluated using the validated 5-point photonumeric Allergan NLF Severity Scale (NLFSS); scores ranged from 0 (“no wrinkle”) to 4 (“very deep wrinkle”). Response was defined as ≥1-point improvement at 6 months. Investigator-assessed responder rate (primary outcome), NLF mean improvement, and subject-assessed responder rate and preference were assessed.
RESULTS: Among the 104 subjects who completed the study, median initial volumes (mL) were 0.8 (range, 0.2–1.4) for Juvéderm Ultra and 0.8 (0.3–1.5) for Restylane; median touch-up volumes were 0.3 (0.1–0.5) and 0.3 (0.1–0.5), respectively. At 6 months, investigator-assessed responder rates were 87.3% for both products, indicating that Juvéderm Ultra was noninferior to Restylane; mean improvement in NLFSS scores from baseline was 1.0 for both products. At 6 months, Juvéderm Ultra and Restylane subject-assessed responder rates were 86.3% and 79.4%, respectively, and mean improvement in NLFSS scores from baseline was 1.2 and 1.0, respectively. Among subjects who expressed a preference, 57.9% preferred Juvéderm Ultra. For both products, the most commonly reported treatment site responses were swelling, firmness, and tenderness; treatment site responses were generally mild or moderate in severity. Juvéderm Ultra had fewer severe responses than Restylane.
CONCLUSIONS: Juvéderm Ultra is noninferior to Restylane and is a safe and effective treatment for correcting moderate NLFs in Chinese subjects.
J Drugs Dermatol. 2016;15(1):70-76.
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.
J Drugs Dermatol. 2011;10(11):1277-1280.
J Drugs Dermatol. 2012;11(9):e1-e4.
Scott KM Barr MD FRCPC,a Arie Benchetrit MD FRCPC,b Mariusz Sapijaszko MD FRCP,c
and Anneke Andriessen PhDd
OBJECTIVE: A 24-week study evaluated clinical efficacy with HA.
METHODS AND MATERIALS: Included were 15 healthy subjects recruited from 4 centers, between ages of 35 to 65 years, who had a Wrinkle Severity Rating Scale (WSRS) score ≥ 3, indicating moderate volume loss. Revanesse® Ultra (Prollenium), a HA dermal filler, was used. Primary study outcome was physicians scored facial volume correction, using the Global Aesthetic Improvement Scale (GAIS), comparing baseline (day 0) versus 24 weeks (end) and blindly assessed photographs. Subject satisfaction and comfort was evaluated using self-administered questionnaires at day 0 and at week 24.
RESULTS: N = 15, 13 female and 2 males with a mean age (years) of 48.52 ( SD ± 10.46) received treatment with HA and completed the 24-week study. At screening they had a moderate (mean 2.85, SD ± 0.45) WSRS score. At week 24 a market facial volume restoration was shown and no adverse events were reported. All patients reported to be satisfied with the obtained results.
CONCLUSION: Good – excellent volume enhancement was noted almost immediately after the HA injections, improving patient reported quality of life aspects. HA treatment was shown to be safe.
J Drugs Dermatol. 2015;14(1):19-23.
Kenneth R. Beer MD FAAD,a Stephanie Bayers BSBA,b and Jacob Beerc| |
J Drugs Dermatol. 2014;13(suppl 1):s17-s20.
Tian-Hua Xu MD,a John ZS Chen MD,b Yuan-Hong Li MD,a Yan Wu MD,a Yao-Jia Luo MD,a Xing-Hua Gao MD,a Hong-Duo Chen MDa| |
Background: L−ascorbic acid has been widely used to treat photo-aged skin. However, its aqueous formula is prone to oxidation. Therefore, a new formula that contains 23.8% L−ascorbic acid and a chemical penetration enhancer was developed.
Objective: Observe the efficacy and safety of topical 23.8% L−ascorbic acid serum on photo-aged skin.
Methods: Twenty Chinese women with photo-aged skin were enrolled in this split-face study. They were treated with topical L−ascorbic acid serum with iontophoresis on one side of the face once a day for 2 weeks; the other side of the face was spared treatment through participants´ self-control. Changes in photo-aged skin were evaluated using a global evaluation, an overall self-assessment, a spectrophotometer, the phase-shift rapid in vivo measurement of skin (PRIMOS) 3D, and a corneometer.
Results: Sixteen of 20 patients (80%) experienced a score decrease of 2 or 3 grades, according to the dermatologist. Fifteen patients (75%) rated their overall satisfaction as excellent or good. Dyspigmentation, surface roughness, and fine lines on the treated side improved significantly.
Conclusion: Topical 23.8% L−ascorbic acid serum is effective for the treatment of photo-aged skin and does not cause any obvious side effects.
J Drugs Dermatol.2012;11(1):51-56.
Topical Formulation Engendered Alteration in p53 and Cyclobutane Pyrimidine Dimer Expression in Chronic Photodamaged Patients
James M. Spencer MD MS,a Summer D. Moon BS,b Kara M. Trapp BA,c and Michael B. Morgan MDd-f| |
J Drugs Dermatol. 2013;12(3):336-340.
Facial Contouring With Fillers, Neuromodulators, and Lipolysis to Achieve a Natural Look in Patients With Facial Fullness
Chytra Anand MD| |
Vivian W. Bucay MD FAAD| |
The Effects of a Daily Skincare Regimen on Maintaining the Benefits Obtained from Previous Chemical Resurfacing Treatments
Suzanne Bruce MD,a Wendy Roberts MD,b Craig Teller MD,c and Lora Colvan BSd| |
OBJECTIVES: To evaluate whether a daily skin care regimen used for 12 weeks could maintain the benefits achieved with AGE and MELA chemical resurfacing treatments.
METHODS: Subjects who completed participation in the AGE and MELA skin resurfacing clinical trial were recruited to participate in a continuation trial and used a daily regimen of MDRejuvena facial products for 12 weeks. No other facial products were permitted. Physicians assessed the severity of individual skin parameters at baseline and week 12 and provided global assessment. Subjects assessed improvement of individual skin parameters at week 12 and provided an overall assessment.
RESULTS: Thirteen subjects participated in the 12-week continuation trial. According to the physician’s global assessment, all subjects demonstrated some level of improvement at week 12 compared to baseline. Physician assessment showed a decrease in severity of all skin parameters assessed at week 12 compared to baseline. According to the subject overall assessment at week 12, 11 of 12 subjects noted some level of improvement, 1 subject saw no improvement, and 1 subject did not provide an overall assessment. Mild to moderate improvement was observed by subjects in all individual skin parameters assessed except for skin discoloration.
CONCLUSIONS: The results of the continuation study demonstrate that use of a daily skin care regimen, which include combination of 2 various strengths of MDRejuvena Rejuvaphyl® Rejuvenating Complex: low strength (LS) and high strength (HS), not only maintains but can enhance the beneficial effects of skin resurfacing treatments for at least 12 weeks.
J Drugs Dermatol. 2016;15(9):1145-1150.
A 12-Month, Prospective, Evaluator-Blinded Study of Small Gel Particle Hyaluronic Acid Filler in the Correction of Temporal Fossa Volume Loss
Amir Moradi MD,a Azadeh Shirazi MD,b and Jeanette Moradi CRCa| |
STUDY DESIGN: This is a US Food and Drug Administration-approved, blinded, prospective, single-center, open-label trial enrolling 20 subjects undergoing subcutaneous injection of SGP-HA for rejuvenation of the temples. Primary outcomes were measured using a standardized grading system—the Hollowness Severity Rating Scale (HSRS)—at each visit by the treating investigator, a blinded physician assessment of randomized photos using the HSRS, and patient questionnaires over a 12-month period. AEs were monitored by the investigator and via patient diaries.
RESULTS: At weeks 4, 12, and 24, and month 12, all graders (ie, investigator, blinded physician assessor, and patients) reported improvement overall in hollowness. At baseline, temporal fossa hollowness was measured as moderate to severe. At week 4 to month 12, temporal fossa was graded at none or only mild hollowness. No touch-ups were necessary at week 4 on all subjects. All AEs were mild or moderate and resolved within 2 weeks.
CONCLUSION: Our study demonstrates clinically significant efficacy and safety in the use of Restylane for temple augmentation and, thus, facial rejuventation.
J Drugs Dermatol. 2013;12(4):470-475.
Deborah S. Sarnoff MD| |
Efficacy of a Comprehensive Serum in Japanese Subjects With Moderate to Severe Facial Hyperpigmentation
Elizabeth T. Makino BS CCRA MBA,a Shoichiro Yano MD,b Tsing Cheng PhD,a Rahul C. Mehta PhDa| |
Whitney P. Bowe MD| |
J Drugs Dermatol. 2013;12(suppl 9):s133-s136.
Derek Ho BSa and Jared Jagdeo MD MSa,b,c| |
OBJECTIVE: We sought to systematically review clinical studies and expert opinions of this 20 mg/ml HA dermal filler and to provide evidence-based recommendations and expert opinions.
METHODS AND MATERIALS: A search of the computerized bibliographic databases Medline, Embase, Embal, Biosis, SciSearch, Pascal, HCAPlus, IPA, and Dissertation Abstracts was performed on August 18th 2014.
RESULTS: Thirteen articles met inclusion and were included in our review: clinical trials with this 20 mg/ml HA dermal filler (10) and expert opinions and questionnaire survey studies of experts (3). This 20 mg/ml HA dermal filler has shown consistent, favorable results for treatment of age-related facial volume loss, aesthetic enhancement, and HIV facial lipoatrophy.
CONCLUSION: HA fillers are safe and effective with minimal recovery time and complications. Future studies with longer follow-up period and use of this 20 mg/ml HA dermal filler on areas other than midface may provide additional efficacy and safety outcomes.
J Drugs Dermatol. 2015;14(9):934-940.
Synergistic Effects of Green Tea and Ginkgo Biloba Extracts on the Improvement of Skin Barrier Function and Elasticity
Patrícia M.B.G. Maia Campos PhD, Mirela D.Gianeti PhD, Daiane G. Mercurio ScM, and Lorena R. Gaspar PhD| |
J Drugs Dermatol. 2014;13(9):1092-1097.
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.
Efficacy of Cream-Based Novel Formulations of Hyaluronic Acid of Different Molecular Weights in Anti-Wrinkle Treatment
Tatjana Pavicic,b Gerd G. Gauglitz,b Peter Lersch,a Khadija Schwach-Abdellaoui,c Birgitte Malle,c Hans Christian Korting,b Mike Farwickaa| |
Background: Due to its strong water-binding potential, hyaluronic acid (HA) is a well-known active ingredient for cosmetic applications. Native HA is proposed to help the skin to retain and maintain elasticity, turgor and moisture.
Objective: To observe the efficacy of topical application of 0.1% hyaluronan formulations of different molecular weights (MW) (50, 130, 300, 800 and 2000 kDa, respectively) in the periocular area as anti-wrinkle treatment.
Material and Methods: Seventy-six female subjects between 30 and 60 years of age with clinical signs of periocular wrinkles applied one of the formulations twice-daily to the area of interest in a randomized fashion for 60 days. Around the other eye, a vehicle control cream was applied. Measurements of skin hydration and skin elasticity were performed before treatment, 30 and 60 days thereafter. At similar time points negative replicas were taken and evaluated by semi-automated morphometry.
Results: All HA-based creams utilized in this study demonstrated a significant improvement in skin hydration and overall elasticity values (R2) when compared to placebo. Measurements of wrinkle depth using mean roughness (Ra) and maximum roughness (Rz) values revealed significant improvement in the 130 and the 50 kDa HA group after 60 days of treatment compared to placebo-treated area.
Conclusion: Topical application of all 0.1% HA formulations used in this study led to significant improvement in skin hydration and elasticity. Application of low-molecular-weight (LMW) HA was associated with significant reduction of wrinkle depth, which may be due to better penetration abilities of LMW HA.
J Drugs Dermatol. 2011;10(9):990-1000.
Shino Bay Aguilera DO FAAD,a Sean Branch DO FAAD,b and Luis Soro DO FAADa| |
Calcium Hydroxylapatite for Augmentation of Face and Hands: A Retrospective Analysis in Italian Subjects
Gabriele F. Muti MD,a Giorgio Astolfi MD,b Massimo Renzi MD,c and Pier P. Rovatti MDd| |
J Drugs Dermatol. 2015;14(9):948-954.
Moetaz El-Domyati MD,a Tarek S. El-Ammawi MD,a Osama Moawad MD,b Walid Medhat MD,a, c Mỹ G. Mahoney PhD,c Jouni Uitto MD PhDc| |
Background: The use of intense pulsed light (IPL) for facial rejuvenation had been the topic of many studies. However, few of them
discussed quantitative changes in extracellular matrix proteins after IPL therapy.
Objective: To objectively quantify the histological changes in extracellular matrix proteins after IPL treatment for facial wrinkles.
Methods: Biopsy specimens were obtained from the periocular area of six volunteers of Fitzpatrick skin type III–IV and Glogau's class I–III wrinkles. They were subjected to three months of IPL treatment (six sessions at two-week intervals). Using histological and immunostaining analysis coupled with computerized morphometric analysis, quantitative evaluation of collagen types I, III and VII, newly synthesized collagen, total elastin and tropoelastin was performed for skin biopsies at baseline, end of treatment, and three months post-treatment.
Results: Clinical assessment of volunteers did not show clinically noticeable improvement in facial wrinkles after IPL treatment. Furthermore, quantitative evaluation of extracellular matrix proteins showed no statistically significant changes (P>0.05) in response to IPL treatment.
Conclusion: Although 50 percent of volunteers showed mild improvement in skin texture at the end of IPL treatment, none of them reported improvement in skin tightening or wrinkles. No statistically significant histological changes were observed three months post IPL treatment.
J Drugs Dermatol. 2011;10(11):1246-1252.
Salman M.S. Alsaad MDa and Maryann Mikhail MDb| |
Objective/Methods: To present dermatologists with a complete review of the literature with regard to anatomy, definition, etiology, and treatment of periocular hyperpigmentation.
Conclusions: Our understanding of the causes and treatment of periocular hyperpigmentation continues to advance. Nevertheless, we are in need of additional controlled clinical trials and novel therapeutic options. Individual patients will likely benefit most from a combination of approaches. Although more randomized clinical studies are necessary, Pfaffia paniculata/Ptychopetalum olacoides B.⁄Lilium candidum L. - associated compound cream seems to be a promising option, with 90% improvement. For patients with increased melanin deposition, quality-switched ruby laser therapy could offer a better treatment option. In the hands of experienced professionals, a surgical option might be suitable, either by autologous fat transplantation or hyaluronic acid filler.
J Drugs Dermatol. 2013;12(2):154-157.
A Two-Center, Open-Label, Randomized, Split-Face Study to Assess the Efficacy and Safety of One Versus Three Intradermal Injection Sites of AbobotulinumtoxinA in the Treatment of Lateral Periocular Rhytides
Sabrina G. Fabi MD,a Hema Sundaram MD,b Isabella Guiha BS,a and Mitchel P. Goldman MDa,| |
OBJECTIVE: To determine the efficacy of one versus three injection sites of AbobotulinumtoxinA (ABO) in the treatment of lateral canthal rhytides.
METHODS: This was a two-center, evaluator-masked, 120 day study in which 40 patients with moderate to severe hyperdynamic lateral canthal rhytides at maximal contracture were randomized to receive one injection of 36 Units of ABO into the middle of the lateral orbital rhytides on one side, with the contralateral side treated with the same total dose of ABO, divided into three intradermal injections of 12 Units each, along the lateral canthal area. A blinded evaluator assessed lateral orbital rhytides at rest and maximal contraction at baseline, 7, 42, 90, and 120 days post treatment. Standardized digital photography and subject self- assessment were performed at each visit.
RESULTS: No statistically significant difference was seen at any visit between sides treated with one injection and those treated with three injections in any evaluation category. There was no difference in adverse events between the two sides.
CONCLUSION: Sites treated with three injections of ABO showed no statistically significant difference from those treated with one injection.
J Drugs Dermatol. 2013;12(8):932-937.
J Drugs Dermatol. 2013;12(10):1177-1179.
Evan A. Rieder MD,a Euphemia W. Mu MD,a and Jeremy A. Brauer MDa,b,c| |
J Drugs Dermatol. 2015;14(9):1023-1026.
Martin Ray MDa and Michael Gold MDb| |
J Drugs Dermatol. 2015;14(11):1268-1271.
Ramin Fathi MD1 and Joel L. Cohen MD FAAD1,2,3| |
J Drugs Dermatol. 2016;15(7):809-815.
J Drugs Dermatol. 2012;11(9):1081-1088.
Hilary Reich MD,a,b Irmina Wallander BA,a Lacie Schulte MS BA,a Molly Goodier BS,a and Brian Zelickson MDa| |
Consensus Recommendations on the Use of Injectable Poly-L-Lactic Acid for Facial and Nonfacial Volumization
Danny Vleggaar MD,a Rebecca Fitzgerald MD,b Z. Paul Lorenc MD FACS,c J. Todd Andrews MD,d Kimberly Butterwick MD,e Jody Comstock MD,f C. William Hanke MD,g T. Gerald O’Daniel MD FACS,h Melanie D. Palm MD MBA,i Wendy E. Roberts MD,j Neil Sadick MD,k and Craig F. Teller MDl| |
J Drugs Dermatol. 2014;13(suppl 4):s44-s51.
Hema Sundaram MD FAAD| |
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.
Histologic Improvement in Photodamage After 12 Months of Treatment With Tretinoin Emollient Cream (0.02%)
Methods: Subjects were female, 18 years of age or older, and instructed to apply tretinoin 0.02% to the treatment areas for 12 months. Histology was undertaken using facial photographs and 2-mm biopsies of the lateral canthus area that were obtained from 3 subjects at baseline and 12 months.
Results: Histopathologic analyses revealed evidence of extensive solar elastosis at baseline for 2 of the 3 subjects who were white, with moderate elastosis observed for the third subject who was African American. Histologic improvements in photodamage following 12 months of treatment with tretinoin 0.02% were observed for each subject. Improvements included smoothing of the epidermis, a slightly thinner keratin layer, and thin, comparatively straight elastic and collagen fibers in the mid- to deep-dermal layer.
Conclusions: The histologic changes in all subjects could be attributed to a remodeling (elastin) or repair (collagen) process that affected the connective tissue fibers in all layers of the dermis. These results suggest that tretinoin 0.02% may be an effective treatment for photodamage, and additional evaluation is warranted in future studies.
J Drugs Dermatol. 2012;11(9):1036-1040.
Effect of Midfacial Volume Augmentation With Non Animal Stabilized Hyaluronic Acid on the Nasolabial Fold and Global Aethestic Appearance
Brian S. Biesman MD FACSa and Whitney P. Bowe MDb| |
METHODS: Twenty subjects with moderate midfacial volume loss and prominence of nasolabial folds underwent injection of the midface with Perlane between May and July, 2009. The average volume administered was 3.68 +/- 0.55 ml. Assessments were performed by the injecting physician and subject self-assessment for 6 months following treatment.
RESULTS: 17 of 20 subjects completed all study visits. At the 6-month follow up visit 16 of 17 subjects were found to have clinically significant improvement of the midface and 14 of 17 subjects were found to have clinically significant improvement of the nasolabial folds. No serious adverse events occurred.
CONCLUSION: In this early stage, proof-of-concept trial, the majority of patients treated demonstrated clinically significant, aesthetically pleasing improvement 6 months after injection of Perlane in the midface.
J Drugs Dermatol. 2015;14(9):943-947.
Safety and Efficacy Evaluation of Tretinoin Cream 0.02% for the Reduction of Photodamage: A Pilot Study
Objective: We performed independent assessments to demonstrate the long-term safety and efficacy of tretinoin emollient cream 0.02% for moderate to severe facial photodamage.
Methods: A single-center, open-label, single-group observational study followed 19 patients over 52 weeks. Efficacy assessments consisted of the Glogau Photodamage Classification Scale and severity grading of photodamage signs and symptoms. Facial photography and biopsies were taken from three subjects at baseline and final visits. Tolerability was assessed by the investigator.
Results: Twelve patients completed 52 weeks of treatment. Mean change in Glogau photodamage demonstrated statistically significant differences at 3, 6, 9, and 12 months (P<.0005). All patients with moderate to severe photodamage had improved to mild photodamage status by 9 months. Statistically significant improvements (P<.05) were observed at all time points for fine wrinkling, tactile roughness, and mottled hyperpigmentation as well as for lentigines at 6, 9, and 12 months and telangiectasia at 12 months. Biopsy samples revealed microscopic improvement in photodamage. Tretinoin cream 0.02% was generally well-tolerated, with few subjects experiencing adverse events.
Limitations: Our pilot study is limited by lack of control and the small study sample.
Conclusions: Tretinoin cream 0.02% was safe and effective for moderate to severe photodamage of facial skin and demonstrated sustainable benefits over an entire year based on the clinically validated Glogau classification system and expert visual grading analysis.
J Drugs Dermatol. 2012;11(1):83-90.
Melissa Meland BS,a Chris Groppi MS,a and Z. Paul Lorenc MDb| |
MATERIALS AND METHODS: The rheological properties of complex viscosity (η*) and elastic modulus (G’) were measured for 2 types of CaHA fillers [CaHA without lidocaine and CaHA (+) with integral 0.3% lidocaine] and 5 HA fillers using an oscillation frequency sweep at a sheer stress of 5 pascal tau (Pa) and an interpolation of 0.7 Hz.
RESULTS: CaHA with and without integral lidocaine demonstrate similar η* and G’ measurements. CaHA with and without integral lidocaine demonstrates higher η* and G’ compared with HA fillers with integral lidocaine.
CONCLUSION: CaHA with integral lidocaine has a similar rheological profile to CaHA without lidocaine: the highest η* and G’ compared with available HA fillers with integral lidocaine.
J Drugs Dermatol. 2016;15(9):1107-1110.
Complementary Antioxidant Function of Caffeine and Green Tea Polyphenols in Normal Human Skin Fibroblasts
Jared Jagdeo MD MS and Neil Brody MD PhD| |
The study of free radicals is particularly relevant in the context of human skin carcinogenesis and photoaging because of these oxidants´ ability to induce DNA mutations and produce lipid peroxidation byproducts, including 4-hydroxy-2-nonenal (HNE). Therefore, it is important to identify and evaluate agents with the ability to modulate intracellular free radicals and HNE. The purpose of this research is to investigate the ability of antioxidants green tea polyphenols (GTPs) and caffeine, alone and in combination, to modulate the hydrogen peroxide (H2O2)-induced upregulation of reactive oxygen species (ROS) free radicals and HNE in normal human skin fibroblast WS-1 cells in vitro. GTPs and caffeine were selected for evaluation because these compounds have demonstrated antioxidative properties in various skin models. Furthermore, GTPs and caffeine share a close natural botanical association as caffeine is present in green tea, as well. Hydrogen peroxide is a well-known generator of free radicals that is produced during endogenous and UV-induced oxidation processes in human skin and was used to upregulate ROS and HNE in normal human fibroblast WS-1 cells. Using a flow cytometry-based assay, the results demonstrate that at 0.001% concentration, green tea polyphenols alone, and in combination with 0.1 mM caffeine, inhibited the upregulation of H2O2-generated free radicals and HNE in human skin fibroblasts in vitro. Caffeine alone demonstrated limited anti-oxidant properties.
J Drugs Dermatol. 2011;10(7):753-761.
Marko Lens MD PhD,a Marie-Helen Podesta Marty PharmDb| |
J Drugs Dermatol. 2011;10(3):262-267.
Danny Vleggaar MD,a Rebecca Fitzgerald MD,b and Z. Paul Lorenc MD FACSc| |
J Drugs Dermatol. 2014;13(suppl 4):s29-s31.
Improved Neocollagenesis and Skin Mechanical Properties After Injection of Diluted Calcium Hydroxylapatite in the Neck and Décolletage:A Pilot Study
Yana Alexandrovna Yutskovskaya MD PhDa and Evgeniya Alexandrovna Kogan MD PhDb| |
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.
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.
Real-time, High-resolution, In Vivo Characterization of Superficial Skin With Microscopy Using Ultraviolet Surface Excitation (MUSE)
Derek Ho BS,a,b Farzad Fereidouni PhD,c Richard M. Levenson MD,c and Jared Jagdeo MD MSa,b,d| |
Fractionated Carbon Dioxide Laser Treatment of Fibroelastolytic Papulosis With Excellent Cosmetic Result and Resolution of Pruritus
Derek Ho BSa and Jared Jagdeo MD MSa,b,c| |
J Drugs Dermatol. 2015;14(11):1354-1357.
J Drugs Dermatol. 2012;11(9):1089-1093.
A Randomized, Split-Face, Histomorphologic Study Comparing a Volumetric Calcium Hydroxylapatite and a Hyaluronic Acid-Based Dermal Filler
Yana Yutskovskaya MD,a Evgenjia Kogan MD,b and Eugene Leshunov MDa| |
OBJECTIVE: To compare neocollagenesis and elastin production stimulated by Radiesse® (calcium hydroxylapatite; CaHA, Merz Pharmaceuticals GmbH) and a hyaluronic acid-based filler (HA; Juvéderm® VOLUMA®).
METHODS: Twenty-four women, aged 35–45, participated in this split-face, comparative study. Punch biopsies were taken 4 and 9 months after supraperiostal injection of each filler into the ipsilateral or contralateral postauricular area. Samples were analyzed for collagens type I and III, elastin, Ki-67, and inflammatory and angiogenic markers.
RESULTS: At month 4, collagen type III was greater with CaHA vs HA (P=0.0052). By month 9, type I staining was higher with CaHA vs HA (P=0.0135), whereas type III was lower with CaHA than HA (P=0.0019). Staining for elastin, Ki-67 and angiogenesis was greatest with CaHA at both timepoints. Inflammatory markers increased most with HA treatment.
CONCLUSIONS: CaHA resulted in more active, physiologic remodeling of the extracellular matrix than HA by stimulating a two-step process whereby collagen type I gradually replaced type III. Increased elastin stimulated by CaHA also indicates active remodeling. The results of this study suggest that, in the first 9 months after treatment, by reconstituting tissue homeostasis without inducing inflammation suggests CaHA has more desirable characteristics for a dermal filler than HA.
J Drugs Dermatol. 2014;13(9):1047-1052.
Home-Based Wrinkle Reduction Using a Novel Handheld Multisource Phase-Controlled Radiofrequency Device
Neil S. Sadick MD,1 Yoram Harth MD,2,3 Andrew S. Dorizas MD,6 Hanna Levy PhD,4 and Avner Shemer MD5| |
PATIENTS AND METHODS: A total of 69 participants (age 54.3 years ± 8.09; age range 37-72 years) were enrolled in the study after meeting all inclusion/exclusion criteria (100%) and providing informed consent. Participants were provided with the tested device together with a user manual and treatment diary, to perform independent treatments at home for 4 weeks. The tested device, (Newa™, EndyMed Medical, Cesarea, Israel) emits 12 W of 1Mhz, RF energy through six electrodes arranged in a linear fashion. Independent control of RF polarity through each one of the 6 electrodes allows significant reduction of energy flow through the epidermis with increased dermal penetration. Participants were instructed to perform at least 5 treatments a week, for one month. Four follow-up visits were scheduled (once a week) during the period of independent treatments at home, following 4 weeks of home treatments, 1 month follow-up visit (1 month after treatment end) and at 3 months follow-up (3 months following treatment end).
Analysis of pre-and post treatment images was conducted by three uninvolved physicians experienced with the Fitzpatrick Wrinkle and Elastosis Scale. Fitzpatrick Wrinkle and Elastosis score of each time point (4 weeks following home use treatments; 1 month follow-up, 3 months follow-up) was compared to baseline.
Participants were asked a series of questions designed to explore usability concerns and level of satisfaction regarding the device use and subjective efficacy.
RESULTS: Altogether, 62 subjects completed the study course and follow-up visits. No unexpected adverse effects were detected or reported throughout the independent treatment. All study participants did not experience any difficulties while operating the tested device for independent wrinkle reduction treatments. Photographic analysis of pre- and post-one month of independent home use treatments, and one and three months follow-up after end of treatment course, was conducted by three uninvolved board certified dermatologists. Analysis of results revealed improvement (downgrade of at least 1 score according to the Fitzpatrick scale) in 91.93%, 96.77%, and 98.39% of study subjects (according to the first, second, and third reviewer, respectively). Results were found to be statistically significant. The majority of study participants were very satisfied from the results of the independent treatment using the tested device for wrinkle reduction.
J Drugs Dermatol. 2014;13(11):1342-1347.
Background:Over the past 10 years, radiofrequency (RF) technology has been utilized for nonablative treatments for the treatment of
rhytides and skin laxity. This manuscript reviews the scientific background of collagen synthesis in vivo and in response to RF energy as
well as a clinical study of 17 patients receiving a series of facial treatments with a 4-MHz monopolar RF (Pellevé,Ellman International,
Inc, Oceanside, NY). Clinical methods, results, and a review of the literature for RF aesthetic treatments of the face are presented.
Methods:Seventeen patients were treated in one site with 6 total treatments scheduled as follows:1 session was performed every 15 days for 2 consecutive sessions, 1 session every month for 2 consecutive sessions, and 1 session every 2 months for 2 consecutive sessions. Both the treating physician and the patients via live viewing and comparison with baseline photographs performed assessment of results. Results are reported as averages across the 17 patients.
Results: Two weeks after the first treatment,patients noted an overall average of 25% to 30% improvement. Just before the last or sixth treatment, there was an average of 50% improvement noted by the physician, with patients ranking an average self-improvement of 48%. The treating physician rated average improvement of 46% compared with baseline,whereas the patients ranked average improvement of 30% compared with baseline at 1 year after treatment was initiated (6 months after the final treatment).Patients find this treatment to be very well tolerated, with minimal to no discomfort and no downtime or significant side effects.
Conclusions: The Pellevé 4-MHz monopolar RF device is effective, safe, and very well tolerated for treating laxity, texture, and wrinkles of the skin without complication or discomfort. Evidence in the literature supports the scientific mechanism of action of acute collagen modification and continued neocollagenesis observed with the system. In this cohort, patients maintain approximately 50% improvement on average at 6 months and a 30% to 50% improvement 1 year after beginning the treatments, 6 months after completion.
Joshua A. Farhadian,a Bradley S. Bloom,b and Jeremy A. Brauera,b,c| |
J Drugs Dermatol. 2015;14(9):1029-1034.
Rebecca S. Danhof MD MPHa and Joel L. Cohen MDa,b,c| |
J Drugs Dermatol. 2016;15(1):111-112.
Pilot, Multicenter, Open-Label Evaluation of Safety, Tolerability and Efficacy of a Novel, Topical Multipotent Growth Factor Formulation for the Periorbital Region
Hema Sundaram MD,a Michael Gold MD,b Heidi Waldorf MD,c Mary Lupo MD,d Vivien L. Nguyen PharmD,e and Jwala Karnik MDe| |
METHODS: Thirty-nine female subjects with mean age of 56.8 years who had periorbital lines and wrinkles, uneven skin texture, puffiness, and lack of skin firmness were enrolled, and 38 completed the study. All subjects applied the multipotent growth factor formulation bilaterally to the periorbital area, twice daily for 60 days. Efficacy and treatment-related adverse events were evaluated at Baseline and days 14, 30, and 60. Investigators rated the periorbital areas based on 10-point scales.
RESULTS: Subjects’ self-reported compliance with treatment was greater than 99% throughout the study. At day 60, all subjects had improvement in infraorbital brightness (≥ 2 points), moistness (≥ 2 points), wrinkles (≥ 1 point), sallowness (≥ 1 point), crepiness (≥ 1 point), smooth texture (≥ 1 point), skin tightness (≥ 1 point), and skin tone (≥ 1 point). Investigator-rated assessments showed ≥ 1-point improvement for lateral canthal wrinkles, dyschromia/mottled pigmentation, skin tone, overall brightness, and moistness. Investigator-rated scoring on the Global Aesthetic Improvement Scale (GAIS) demonstrated that 67.6% of subjects were much improved/improved at day 14, and 63.1% remained improved at day 60. Overall, 76.2% and 79.0% of subjects were very pleased/pleased/mostly pleased with the appearance of their infraorbital and lateral canthal areas at day 60. Adverse events comprised one case of mild canthal erythema, and one case of mild eye irritation, both of which were respectively resolved.
CONCLUSIONS: This pilot study demonstrated that the topical multipotent growth factor formulation was safe, effective and well tolerated for periorbital skin rejuvenation.
J Drugs Dermatol. 2015;14(12):1410-1417.
Objective: To compare injections of filler with microcannulas versus hypodermic needles in terms of ease of use, amount of filler required to achieve desired aesthetic outcome, perceived pain by patient, adverse events such as bleeding and bruising and to demonstrate the advantages of single-port injection technique with the blunt-tip microcannula.
Materials and Methods:Ninety-five patients aged 30 to 76 years with a desire to augment facial, décolleté, and hand features were enrolled in the study. Subjects were recruited in a consecutive manner from patients interested in receiving dermal filler augmentation. Each site was cleaned with alcohol before injection. Anesthesia was obtained with a topical anesthesia peel off mask of lidocaine/tetracaine. Cross-linked hyaluronic acid (20 mg to 28 mg per mL) was injected into the mid-dermis. The microcannula or a hypodermic needle was inserted the entire length of the fold, depression or lip and the filler was injected in a linear retrograde fashion. The volume injected was variable, depending on the depth and the extent of the defect. The injecting physician assessed the ease of injection. Subjects used the Visual Analog Scale (0-10) for pain assessment. Clinical efficacy was assessed by the patients and the investigators immediately after injection, and at one and six months after injection using the Global Aesthetic Improvement Scale (GAIS) and digital photography.
Results: Overall, the Global Aesthetic Improvements Scale (GAIS) results were excellent (55%), moderate (35%), and somewhat improved (10%) one month after the procedure, decreasing to 23%, 44%, and 33%, respectively, at the six month evaluation. There was no significant differences in the GAIS score between the microcannula and the hypodermic needle. However, the Visual Analog Scale for pain assessment during the injections was quite different. The pain was described as 3 (mild) for injections with the microcannula, increasing to 6 (moderate) for injections with the hypodermic needle. Bruising and ecchymosis was more marked following use of the hypodermic needle.
Conclusion:Using the blunt-tip microcannula as an alternative to the hypodermic needles has simplified filler injections and produced less bruising, echymosis, and pain with faster recovery.
J Drugs Dermatol. 2012;11(9):1098-1103.
Flor A. Mayoral MD,a Julie R. Kenner MD PhD,b and Zoe Diana Draelos MDc| |
J Drugs Dermatol. 2014;13(4):414-421.
J Drugs Dermatol. 2012;11(1):106-108.
W.Walsh Thomas MDa and Jason D. Bloom MDb| |
Successful Treatment of Calcium Hydroxylapatite Nodules With Intralesional 5-Fluorouracil, Dexamethasone, and Triamcinolone
Shino Bay Aguilera DO,a Miguel Aristizabal MD,b and Ann Reed DOc| |
J Drugs Dermatol. 2016;15(9):1142-1143.
The projections of increases in the number of skin of color patients over the next several decades, necessitates expertise in cultural competence for health care providers. Acquiring competency begins with practitioners reflecting on their self identity and personal beliefs. Additionally, understanding African-American cultural habits and practices and their impact on disease is critically important. We review, in this article, the fundamentals of becoming cultural competent. Patients are best served when their physician embraces their culture, their view of the health care system as well as habits and practices.
J Drugs Dermatol. 2012;11(4):460-465.
Two Randomized, Controlled, Comparative Studies of the Stratum Corneum Integrity Benefits of Two Cosmetic Niacinamide ⁄ Glycerin Body Moisturizers vs. Conventional Body Moisturizers
Jeremy C. Christman MS,a Deborah K. Fix BS MBA,b Sawanna C. Lucus BS,a Debrah Watson BS,a Emma Desmier BS,a Rolanda J. Johnson Wilkerson PhD,a Charles Fixler MDb| |
Methods: 63 and 58 female subjects were enrolled and randomized in an incomplete block design to six of nine products (eight moisturizers or no treatment control) in studies 1 and 2, respectively. The primary endpoints included visual dryness by a qualified skin grader, skin hydration as measured by Corneometer, and barrier integrity as measured by transepidermal water loss (TEWL). The primary comparisons for the two niacinamide/glycerin moisturizers were to the other six moisturizers and to the no treatment control for each endpoint.
Results: The two niacinamide/glycerin moisturizers demonstrated an overall better solution towards rapid and prolonged improvement of cosmetic xerosis due to functional improvement of stratum corneum barrier function compared to no treatment and the other moisturizers tested.
Conclusions: These studies establish the benefit of including niacinamide in a body moisturizer to improve the integrity of the stratum corneum and thus reduce cosmetic xerosis over time.
J Drugs Dermatol. 2012;11(1):22-29.
An Evaluation of Efficacy and Tolerability of Novel Enzyme Exfoliation Versus Glycolic Acid in Photodamage Treatment
Maria Mekas BSN,a,b Jennifer Chwalek MD,a,c Jennifer MacGregor MD,a,d and Anne Chapas MDa,c| |
METHODS: 75 female subjects with mild to moderate photodamage, all skin types, and ages 31-70 years, were enrolled. In this 12 week study of twice daily self-treatments, patients were assigned to one of 3 groups; Group 1 (n-19) was assigned hydrolyzed roe cream, Group 2 (n=17), 4% glycolic acid, or Group 3 (n-16), 8% glycolic acid plus 2% citric acid. All patients used the same mild face wash and SPF 30 sunscreen throughout the study. Patients were evaluated at weeks 0, 8 and 12 for objective and subjective tolerability, improvement in photodamage by VISIA Complexion Analysis, modified Packman and Gans method, Visual Analog Scale (VAS), and answered an opinion questionnaire.
RESULTS: Group 1 improved in skin clarity from a VAS 44.1 to 55.7 (P=0.0317) at week 12. VISIA mean scores correlated with office evaluation showing improvement in brown spots from 453 to 417 (P = 0.0115) at 12 weeks. Group 2 improved in superficial fine lines at week 8 (-5.9, P=0.0428) and week 12 (-9.1, P=0.0019). Group 3 improved at week 12 in skin clarity (11.5, P = 0.0469) and skin roughness (-13.3, P = 0.0426), and in hyperpigmentation at week 8 (-9.4, P=0.0462) and week 12 (-14.6, P= 0.0019).
CONCLUSION: Topical hydrolyzed roe protein used twice daily improves skin clarity. It has good tolerability with fewer instances of stinging and burning than the other glycolic acid containing creams. Patient’s opinions of the 3 products were similar.
J Drugs Dermatol. 2015;14(11):1306-1319.
Isabela T. Wieczorek MD,a Brian P. Hibler BS,b and Anthony M. Rossi MDc| |
J Drugs Dermatol. 2015;14(9):1043-1051.
Patrick Micheels MD,a Stéphanie Besse MD,b and Didier Sarrazin MDc| |
METHOD: The “resistance traction test” and “cohesiveness test” were conducted according to standard methods. Juvéderm® Volbella™ gel was injected into the buttock area, both in the superficial reticular and mid-reticular dermis. Tissue samples were analyzed at days 0, 15, and 90 by histology and immunohistochemistry, and visualized using electron microscopy. For Volbella™ gel, the same ultrasound devices as previously used were employed.
RESULTS: Prior to staining, Volbella™ gel presented resistance to spreading, suggesting a certain degree of cohesiveness. When smeared between two slides and following toluidine blue staining, the gel was visible through the microscope in the form of multiple tiny discrete particles, possibly resulting from gel desintegration. At 1/3 dilution with saline serum, Volbella™ gel disintegrated into several lumps, whereas at 1/1 dilution, Volbella gel appeared more cohesive. Yet when adding one drop 70% ethanol, the gel resembled a poorly defined magma, with numerous small lumps. On ultrasound, Volbella™ gel was found to leak in the hypodermis. On histological analysis, Volbella™ gel was visible as pools of variables sizes, particularly in the superficial and mid-reticular dermis, but also hypodermis.
CONCLUSION: Juvéderm Volbella™ gel appears to be a gel characterized by low-medium cohesiveness. The study findings, combined with our previous work, show that HA fillers using Vycross™ technology are not ideally suited for superficial use, unlike HA fillers using CPM technology™.
J Drugs Dermatol. 2016;15(9):1092-1098.
Safety and Effectiveness of Small and Large Gel-Particle Hyaluronic Acid in the Correction of Perioral Wrinkles
Background: FDA-approved for the correction of moderate-to-severe facial wrinkles and folds, small gel-particle hyaluronic acid (SGP-HA, Restylane,® Medicis Aesthetics, Inc., Scottsdale, AZ) and large gel-particle hyaluronic acid (LGP-HA, Perlane,® Medicis Aesthetics, Inc., Scottsdale, AZ) were studied to evaluate their safety for the correction of oral commissures, marionette lines, upper perioral rhytides and nasolabial folds (NLFs).
Objectives: The primary objective of this study was to investigate the safety of SGP-HA and LGP-HA in treating facial wrinkles and folds around the mouth; the secondary objective was to evaluate the effectiveness of these products.
Methods: This open-label, 4-week study at two US centers evaluated SGP-HA and LGP-HA in patients who intended to undergo intradermal injection for correction of of perioral wrinkles and folds. At screening, a 5-grade Wrinkle Severity Rating Scale (WSRS) was used to evaluate the baseline appearance of bilateral NLFs, and a 6-grade Wrinkle Severity (WS) scale was used to evaluate the appearance of bilateral oral commissures, marionette lines and upper perioral rhytides. To qualify, each patient must have had moderate-to-severe wrinkles at one pair of marionette lines and upper perioral rhytides. Each wrinkle was treated to optimal correction with either SGP-HA or LGP-HA at the discretion of the treating investigator. All reported local and systemic adverse events (AEs) were recorded. At two weeks after treatment or touch-up, the treating investigator and the patient assessed appearance using the Global Aesthetic Improvement Scale (GAIS).
Results: Twenty patients with a mean age of 59.6 years (range 49 to 65 years) were treated with an average of 5.58±1.15 mL of HA for the entire perioral area. Treatment areas included NLFs, marionette lines, oral commissures and perioral rhytides. Eighteen of 20 patients received both SGP-HA and LGP-HA. Product was injected into the mid or deep dermis using primarily linear threading and multiple punctate pools. Patients experienced a total of 66 treatment-emergent AEs (TEAEs); each patient experienced at least one TEAE. The reported events in decreasing order of occurrence were bruising, tenderness, swelling, redness, headache and discomfort. Bruising was more common in the NLFs and marionette lines than in the oral commissures and perioral rhytides. Tenderness occurred more often in the perioral rhytides than in the other areas. The maximum intensity of all TEAEs was considered mild. Most TEAEs resolved within seven days, with an average duration of four days. No serious TEAEs occurred during the study. One hundred percent of GAIS evaluations by both investigators and patients indicated improvement, regardless of filler used or area treated.
Conclusion: Both SGP-HA and LGP-HA were found to be safe and effective for the correction of perioral wrinkles and folds, with few differences among treatment areas Both investigator and patient GAIS evaluations indicated aesthetic improvement after SGP-HA and LGP-HA treatment in the perioral area.
J Drugs Dermatol. 2011;10(9):982-987.
Understanding, Avoiding, and Treating Potential Adverse Events Following the Use of Injectable Poly-L-Lactic Acid for Facial and Nonfacial Volumization
Danny Vleggaar MD,a Rebecca Fitzgerald MD,b and Z. Paul Lorenc MD FACSc| |
J Drugs Dermatol. 2014;13(suppl 4):s35-s39.
Reduction of Facial Redness With Resveratrol Added to Topical Product Containing Green Tea Polyphenols and Caffeine
Georgina Ferzli MD MS, Mital Patel MD, Natasha Phrsai BS, and Neil Brody MD PhD| |
METHODS: Subjects (n=16) presenting with facial redness applied the resveratrol-enriched product twice daily to the entire face. Reduction in redness was evaluated by trained staff members and dermatology house staff officers. Evaluators compared clinical photographs and spectrally enhanced images taken before treatment and at 2-week intervals for up to 12 weeks.
RESULTS: 16 of 16 clinical images showed improvement and 13 of 16 spectrally enhanced images were improved. Reduction in facial redness continued to evolve over the duration of the study period but was generally detectable by 6 weeks of treatment. Adverse effects were not observed in any subject.
CONCLUSION: The skin product combination of resveratrol, green tea polyphenols, and caffeine safely reduces facial redness in most patients by 6 weeks of continuous treatment and may provide further improvement with additional treatment.
J Drugs Dermatol. 2013;12(7):770-774.
The Effect of Benzoyl Peroxide 9.8% Emollient Foam on Reduction of Propionibacterium acnes on the Back Using a Short Contact Therapy Approach
Benzoyl peroxide (BP) exerts its therapeutic effect for acne vulgaris through reduction of Propionibacterium acnes. A 1.0 to 2.0 log reduction in P acnes has been demonstrated primarily on the face with use of “leave-on” BP formulations, but also with some BP cleansers. In addition to use for facial acne vulgaris, cleanser formulations of BP are commonly used for truncal acne vulgaris due to ease of use on a large body-surface area and to avoid bleaching of fabric. To date, evaluation of P acnes reduction on the trunk has not been well studied with BP formulations, especially with the use of recognized and standardized methods to accurately determine P acnes colony counts. A previous study demonstrated that a BP 8% cleanser did not reduce counts of P acnes on the back when subjects were instructed to apply the cleanser in the shower, allow it to dry for 20 seconds on the skin, and then rinse off the cleanser. Evaluation of specified time intervals between application on the back and rinsing with BP formulations would help to better define the necessary skin contact time associated with high reductions of P acnes (>90%), recognizing also the potential roles of BP concentration and vehicle. This 2 week study using quantitative bacteriologic cultures evaluates the effectiveness of BP 9.8% emollient foam in reducing P acnes levels on the back with 2 minutes of skin contact time and compares results with a BP 5.3% “leave-on” emollient foam formulation. Short contact therapy utilizing a 2 minute skin contact time with BP 9.8% emollient foam used once daily over a 2 week duration was highly effective in reducing the quantity of P acnes organisms on the back and provided comparable colony count reduction to “leave on” therapy using BP 5.3% emollient foam.
J Drugs Dermatol. 2012;11(7):830-833.
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.
Safety and Efficacy of a New Device Combining Radiofrequency and Low-Frequency Pulsed Electromagnetic Fields for the Treatment of Facial Rhytides
Methods: Thirty-one subjects with facial wrinkles and rhytides were entered into this study. Every subject received 10 treatments of the face with a device that combines 1 MHz radiofrequency with PEMF with a flux of 15 gauss. Patients rated the pain level immediately after the treatment by using a visual analog scale (VAS) for pain. Side effects were recorded at every visit. The study's efficacy end point was evaluated by 2 blinded physicians who rated the standardized pictures from baseline and 3-month follow-up using the Fitzpatrick Wrinkle and Elastosis Scale (FWES).
Results: No unexpected adverse side effects were detected or reported for the duration of the study. Both raters recognized improvements of at least 1 grade on the FWES in 30 of 31 subjects (97%). The score decreased from 5.2 before the first treatment to 3.6 at 3 months after the last treatment. Furthermore, all patients rated the treatment to be free of pain on the VAS pain scale.
Conclusion: The results of this study show that the combination of multipolar RF with PEMF is a safe, effective, and painless approach to treat facial rhytides and is suitable to answer the demands of patients for safe treatments without pain or downtime.
J Drugs Dermatol. 2012;11(11):1306-1309.
Erling Thom PhD| |
Amongst various treatment methods and substances, oral supplementation with a specific bioavailable proteoglycan stands out as a promising new therapeutic treatment method.
J Drugs Dermatol. 2016;15(8):1001-1004.
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Trial of a Novel Nutritional Supplement Product to Promote Healthy Skin
Steven H. Dayan MD,a,b John P. Arkins BS,c Vinny Sharma BS,d Elaine Paterson PhD,e David Barnes PhDf| |
Background: Despite an abundance of nutritional supplements, very few well-controlled trials have assessed their beneficial effect on the skin, such as hydration, antioxidant levels, texture or appearance. The objective of the following placebo-controlled, double-blind study was to determine the effects of the Skin Health Experimental Product (SHEP) on skin health.
Methods: The study enrolled healthy men and women aged 30 years or older. Subjects were randomized to receive a twice-daily regimen of SHEP or placebo. The effects SHEP had on overall skin appearance and health were assessed by measuring improvements in: (1) skin hydration using a closed-aperture transepidermal water-loss moisture meter and a vapometer; (2) skin texture using silicon profilometry; (3) skin carotenoid concentration using Raman spectrometry; and (4) reported self-image assessments using the Global Aesthetic Improvement Scale (GAIS).
Results: SHEP-treated subjects demonstrated a significant reduction in fine lines compared to the placebo-treated group. Raman spectroscopy showed that SHEP increased carotenoids at some measurement sites. Based on the GAIS, SHEP-treated subjects were three times more likely to perceive an improvement in their appearance compared to placebo-treated subjects (P>0.049).
Conclusion: The orally-administered SHEP nutritional supplement improves skin texture, carotenoid levels in specific areas of the hand, and improves patients' perception of skin health.
J Drugs Dermatol. 2011;10(9):1106-1114.
The Evaluation of Hyaluronic Acid, With and Without Lidocaine, in the Filling of Nasolabial Folds as Measured by Ultrastructural Changes and Pain Management
Josefina Royo de la Torre MD, Paloma Cornejo MD, Gema Pérez MD, Irene Cruz MD, Estefania Muñoz BSc, Maria J. Isarría MD, and J. Moreno-Moraga MD| |
OBJECTIVE: To compare the 1-year clinical results of filling the nasolabial fold with 2 types of filler: large-gel particle HA and large-gel particle HA plus 0.3% lidocaine (HA+L). We compared the level of pain during treatment and 10 minutes after treatment and assessed the safety and efficacy profile, satisfaction, and histological findings (using reflectance confocal microscopy [RCM]).
MATERIALS and METHODS: We performed a comparative, parallel-group, double-blind trial with an external observer (blinded to the type of treatment administered). The filler was applied to the nasolabial fold in 119 patients (HA in 62 patients and HA+L in 57). Patients were followed at months 3, 9, and 12. Pain was evaluated using a visual analog scale. Efficacy and satisfaction were evaluated using the Wrinkle Severity Rating Scale and the Global Aesthetic Improvement Scale. RCM images (n=32) were taken at baseline and at months 3 and 12.
RESULTS: Pain: The severity of pain was decreased in patients treated with HA+L on application (P<.001) and 10 minutes later (P=.008). Efficacy and satisfaction: No significant differences existed between the 2 groups at months 3, 9, and 12. RCM: Skin rejuvenation occurred with a 32% increase in the height of the dermoepidermal junction at month 12 (P<.001), which was similar in both groups. Adverse events: At month 3, the most common adverse events (AEs) were erythema (68%) and hematoma (11%). No AEs were recorded at months 9 or 12.
CONCLUSION: The use of HA+L provides pain relief without affecting efficacy, satisfaction, safety, or the duration of results. RCM showed that the changes in the dermoepidermal junction represented a histological improvement in the skin with similar results in both groups.
J Drugs Dermatol. 2013;12(3):e46-e52
Safety and Efficacy of a Cohesive Polydensified Matrix Hyaluronic Acid for the Correction of Infraorbital Hollow: An Observational Study With Results at 40 Weeks
Oscar Hevia MD,a,b Bernard H. Cohen MD,b,c and David J. Howell PhDd| |
OBJECTIVE: The objective of this study was to determine the safety and efficacy of the latest hyaluronic acid filler, created with a cohesive polydensified matrix, with a low elasticity and viscosity, for infraorbital hollows correction.
METHODS AND MATERIALS: Subjects (49) with at least a grade 2 Merz infraorbital hollow scale in the Validated Assessment Scales for the mid face (0-4) of the right and/or left side were photographed and treated at baseline, and with a touch up treatment after 2 weeks if necessary. Subjects were also photographed at 2, 6, and 10 months after baseline, with optional retreatment at 6 months. The photographs were graded by a blinded sub-investigator.
RESULTS: Mean hollowness scores for both eyes, either individually or combined, at 2, 6, and 10 months were considerably improved compared to baseline (P <.001). No serious adverse events were reported. Of the 46 subjects completing the study, 31 (66%) did not request retreatment after 6 months. At 10 months, 27/31 (87%) still exhibited a hollowness improvement of at least 1-point from baseline.
CONCLUSION: Belotero Balance was safe and effective for the correction of infraorbital hollows.
J Drugs Dermatol. 2014;13(9):1030-1036.
The Efficacy and Tolerability of Dapsone 5% Gel in Female vs Male PatientsWith Facial Acne Vulgaris: Gender as a Clinically Relevant Outcome Variable
Objective: To evaluate the effect of gender on the efficacy and tolerability of dapsone 5% gel.
Methods: This was a pooled analysis of data from 2 identical phase 3 randomized, double-blind, and vehicle-controlled trials (DAP0203 and DAP0204) of dapsone 5% gel conducted in the United States and Canada between November 2002 and September 2003. A total of 2,898 patients with acne vulgaris were included in the pooled analysis. Of these, 1,453 patients (753 female, 700 male) received dapsone 5% gel twice daily, and 1,445 patients (767 female, 678 male) received vehicle twice daily. End points included the mean percentage reduction from baseline in acne lesion counts and the proportion of patients achieving clinical success (Global Acne Assessment Scale score of 0, clear skin, or 1, almost clear skin). Assessments were performed at baseline and at weeks 2, 4, 6, 8, and 12.
Results: The mean percentage reduction in acne lesion counts at 12 weeks was significantly greater in females than males in both treatment groups. The mean reduction in total lesion counts in dapsone-treated females and males was, respectively, 46.6% vs 35.8% (P<.0001). Reductions in papulopustular and comedonal lesion counts were likewise significantly higher in female than male patients (each P<.0001). Significantly more dapsone-treated females than males achieved clinical success (48.6% vs 34.4%; P=.0003).
Conclusion: The response to dapsone 5% gel appears to be influenced by gender, with female patients experiencing a significantly greater reduction in acne lesion counts and a significantly higher clinical success rate following 12 weeks of treatment. These data suggest that gender is a novel predictor of outcome that should be considered in acne clinical trial design and analysis.
J Drugs Dermatol. 2012;11(12):1417-1421.
Andrew F. Alexis MD MPHa and Paul Blackcloud BA| |
J Drugs Dermatol. 2013;12(suppl 9):s123-s127.
Mary P. Lupo MD FAAD| |
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.
Objective: To evaluate discrepancy in size between the excised full-thickness skin and the excision (donor) site.
Methods: Data from 20 cases of full-thickness excisions was reviewed and analyzed.
Results: There was a considerable difference in length of both the short and long axes between the excised full-thickness skin and the excision site.
Conclusions: The initial size of a full-thickness skin graft should be smaller than the defect it is planned to cover.
J Drugs Dermatol. 2012;11(4):520-523.
Richard L. Gallo MD PhD,a Vivian W. Bucay MD,b Ava T. Shamban MD,c Janice Lima-Maribona DO,d Amy B.
Lewis MD,e Cherie M. Ditre MD,f Flor A. Mayoral MD,g Michael H. Gold MDh
J Drugs Dermatol. 2015;14(7):669-674.
Single Blind, Randomized, Controlled Trial of a Lightening Product With and Without Iontophoresis versus Tretinoin and Vehicle for Hyperpigmentation
Molly Wanner MD MBA,a Neil Houston BA,b Emilia Javorsky MPH,c Minsheng Yuan MD,d
Maria Alora-Palli MD,e Alexa B. Kimball MD MPHf
OBJECTIVE: To compare the efficacy of a new skin lightening product with and without iontophoresis to a known effective product (tretinoin) and placebo on hyperpigmentation caused by lentigines and/or melasma. Secondary objectives included an assessment of the product’s effects on the appearance of rhytides and roughness.
METHODS AND MATERIALS: Eighty subjects were randomized into one of four treatment groups: proprietary lightening product, proprietary lightening product with iontophoresis, tretinoin 0.05% cream, or vehicle control. Seventy-four subjects completed all study visits. Blinded assessments of subjects were performed at each visit under ambient and Wood’s light.
RESULTS: The proprietary skin lightening product improved facial hyperpigmentation versus placebo under ambient light (P = 0.05) and Wood’s lamp (P = 0.01) examination. Tretinoin also improved facial hyperpigmentation versus placebo under Wood’s lamp (P = 0.01). The proprietary product was better tolerated than tretinoin, with fewer subject reported side effects.
CONCLUSION: The investigational product was effective and may be better tolerated than tretinoin cream.
J Drugs Dermatol. 2015;14(1):13-18.
Safe and Efficacious Use of a Topical Retinoid Under Occlusion for the Treatment of Mycosis Fungoides
Daniel Aires MD JD,a Tarek Shaath BS,c Garth Fraga MD,b
Anand Rajpara MD,a Ryan Fischer MD,a Deede Liu MD,a
The Impact of Natural Sunlight Exposure on the UVB-Sun Protection Factor (UVB-SPF) and UVA Protection Factor (UVA-PF) of a UVA/UVB SPF 50 Sunscreen
Thomas J. Stephens PhD,a James H. Herndon Jr. MD FAAD,b Luz E. Colón MS CCRC CCRA,c Ronald W. Gottschalk MD FRCPCc| |
Methods: These two randomized, controlled, evaluator-blinded, single-center trials were conducted according to the methods outlined in the 2007 Proposed Amendment to the Final Monograph, “Sunscreen Drug Products for Over-the-Counter Human Use.” Sunscreen samples were applied to glass plates and exposed to ultraviolet radiation in the form of natural sunlight in four minimal erythemal doses (MED) ranging from 2–16 MED (42–336 mJ/cm2). Three test sites were identified on the back of each study subject. Exposed sunscreen (one of four doses), unexposed sunscreen, and a UVB-SPF 15 control sunscreen were applied to the three test sites in a randomized fashion, followed by UV irradiation of incremental doses. Erythema and pigment darkening responses were assessed immediately following UV exposure and again 16–24 hours (erythema) or three to 24 hours (pigment darkening) after exposure. UVB-SPF and UVA-PF values were calculated for the exposed and unexposed samples.
Results: The calculated UVB-SPF and UVA-PF values for all test samples (exposed and unexposed) were >50 and >9, respectively, which were greater than the stated UVB-SPF and UVA-PF values on the product label. No differences were observed between the exposed and unexposed samples in UVB-SPF or UVA-PF.
Conclusion: The UVA and UVB protection using standard evaluation techniques of Cetaphil UVA/UVB Defense SPF 50 remains stable despite exposure of the sunscreen to natural sunlight containing UVB ranging from 2–16 MED (41–336 mJ/cm2) and coexistent UVA.
J Drugs Dermatol. 2011;10(2):150-155.
Evaluation of a Prescription Strength 4% Hydroquinone/10% L-Ascorbic Acid Treatment System for Normal to Oily Skin
Suzanne Bruce MDa and JoAnne Watson DPMb| |
Methods: Patients with minimal or mild facial photodamage and hyperpigmentation, and normal to oily facial skin, used the treatment system for 12 weeks.
Results: Of 34 females enrolled, 30 completed. Median scores for the overall integrated assessment of photodamage, overall intensity of pigmentation, fine lines and wrinkles, tactile roughness, and laxity were significantly improved at week 12 compared with baseline. Furthermore, ≥90 percent of patients considered their skin was smoother, softer, more evenly toned, and more radiant, and 100 percent were satisfied with the overall appearance of their skin.
Conclusion: The treatment system can help to ameliorate early signs of photodamage in normal to oily skin.
J Drugs Dermatol. 2011;10(12):1455-1461.
Jeremy A. Brauer MD,a,d David H. McDaniel MD,b Bradley S. Bloom MD,d Kavitha K. Reddy MD,a
Leonard J. Bernstein MD,a,c and Roy G. Geronemus MDa,d
OBJECTIVE: We investigated the safety and efficacy of a fractionated 1927nm non-ablative thulium laser for the treatment of photo-induced pigmentation.
METHODS: Prospective multi-center study of subjects with clinically identifiable photopigmentation. The study protocol was approved by BioMed Institutional Review Board (San Diego, CA). Subjects received two treatments with a non-ablative 1927nm fractionated thulium laser (Fraxel Dual 1550/1927 Laser System, Solta, Hayward CA), energy level of 10mJ, coverage of 40% and 4-6 passes. Subject pain, erythema and edema were recorded immediately after treatment. Two dimensional photography was obtained before each treatment and at one and three month follow up visits. Independent blinded physician assessment was performed evaluating overall improvement in appearance as well as pigment specific improvement.
RESULTS: Forty men and women, ages 30 to 80 years, Fitzpatrick skin types I-IV, with photo-induced facial pigmentation were enrolled and treated, and 39 completed the three month follow up visit. Mean pain sensation for subjects during laser treatments was reported to be 4.3 on a 10-point scale. Mean scores for erythema, edema, and skin roughness throughout all treatments indicated moderate erythema, mild edema and mild skin roughness. Assessment of overall improvement was graded as moderate to very significant in 82% of subjects at one month and in 69% of subjects at three months after the second treatment. Assessment of lentigines and ephelides demonstrated moderate to very significant improvement in approximately 68% of subjects at the one month and in 51% of subjects at three months after the second treatment. Independent blinded physician assessment of randomized photography also demonstrated a durable response at three month follow up visit. Treatment was well tolerated and no serious adverse events related to treatment were observed or reported. Study limitations included a limited number of male subjects, lack of Fitzpatrick skin types V and VI, and decrease in improvement at 3 months post-treatment.
CONCLUSIONS: Two treatments with a 1927nm non-ablative fractionated thulium laser produced moderate to marked improvement in overall appearance and pigmentation with high patient satisfaction. The response to treatment was maintained at one and three months follow up.
J Drugs Dermatol. 2014;13(11):1317-1322.
Tatjana Pavicic MD| |
J Drugs Dermatol. 2013;12(9):996-1002.
A Randomized, Double-blind, Split-face Study Comparing the Efficacy and Tolerability of Three Retinol-based Products vs. Three Tretinoin-based Products in Subjects With Moderate to Severe Facial Photodamage
Michael Babcock MD,1 Rahul C. Mehta PhD,2 Elizabeth T. Makino BS CCRA MBA2| |
J Drugs Dermatol. 2015;14(1):24-30.
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.
Evaluation of a Hydroquinone-Free Skin Brightening Product Using In Vitro Inhibition of Melanogenesis and Clinical Reduction of Ultraviolet-Induced Hyperpigmentation
Elizabeth T. Makino BS CCRA MBA,a Sujatha Sonti PhD,a Monya L. Sigler PhD,b Piyush Jain PhD,c Ajay Banga PhD,c and Rahul C. Mehta PhDa| |
METHODS: Select formulations were tested in several studies using the MelanoDerm™ Skin Model (MatTek Corporation, Ashland, MA) to assess the ability of the product to reduce melanin production and distribution. A single-center, double-blind comparison clinical study of 18 subjects was conducted to evaluate the efficacy of the product in reducing ultraviolet-induced hyperpigmentation. Test sites were irradiated with 1.0, 1.5, 2.0, and 2.5 minimal erythema doses. After 5 days, to allow for pigmentation development, the product or 4% HQ cream was applied to the respective test sites, once daily for 4 weeks. Chroma Meter measurements (L* brightness) and standardized digital photographs were taken of the test sites twice a week.
RESULTS: The test product resulted in greater reduction in melanin as measured by melanin content and histological staining compared with the positive control in the MelanoDerm Skin Model. The product also demonstrated statistically significant reductions in pigmentation compared with baseline (all P≤.0001) at the end of the clinical study, and produced greater increases in L*, compared with 4% HQ. Results from these studies indicate that a product designed to affect multiple pathways of melanogenesis and melanin distribution may provide an additional treatment option beyond HQ for hyperpigmentation.
J Drugs Dermatol. 2013;12(3 suppl 1):s16-s20.
Does Increasing the Dose of Abobotulinumtoxina Impact the Duration of Effectiveness for the Treatment of Moderate to Severe Glabellar Lines?
John H. Joseph MD,a Laura L. Eaton RN BSN,b James Robinson MS,c Allison Pontius MD,d and Edwin F.Williams III MDd| |
Comprehensive Thermoregulation for the Purpose of Skin Tightening Using a Novel Radiofrequency Treatment Device: A Preliminary Report
Douglas J. Key MD| |
METHODS: A retrospective chart review of 18 subjects undergoing thermistor-controlled subdermal skin tightening via percutaneous radiofrequency was conducted. During the treatment, epidermal temperature was concurrently monitored by a handheld infrared laser thermometer and a forward looking infrared camera system and peak temperatures readings were reported and evaluated.
RESULTS: Mean temperatures of 43.6 and 38.2oC were reported for the infrared camera and infrared thermometer. The Bland-Altman plot analysis reported a bias of 5.38oC and 95% limits of agreement between 0.60 and 10.15oC. Additionally, the mean difference or bias of 5.38oC was statistically significant (P less than 0.0001).
CONCLUSION: Our preliminary data supports a superior form of thermoregulation for the purposes of skin tightening that integrates continuous subsurface and epidermal temperature monitoring.
J Drugs Dermatol. 2014;13(2):185-189.
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.
Michael H. Gold MD,a,b Leon H. Kircik MD,c-e Vivian W. Bucay MD,f,g
Monika G. Kiripolsky MD,h,i and Julie A. Biron BSca
OBJECTIVE: To determine the efficacy of a new topical formulation of 1% retinol and the effects of this same formulation using a 0.5% retinol concentration to minimize irritation.
METHODS: Patients at 2 sites (n=6, n=5) with photodamaged skin applied a novel suspension of retinol (1%) daily to their faces for 8 to 12 weeks. Clinicians graded improvement in ultraviolet-induced features at 4 to 6 weeks and at 8 to 12 weeks. Positive results of the observational pilot study warranted a follow-up study on the low concentration. At a third site, females (n=30) with facial photodamage applied the same formulation with or without retinol (0.5%) daily for 8 weeks. Twenty-two subjects applied the test product and 8 applied vehicle according to a randomized, double-blinded, institutional review board–approved protocol. Improvements in photodamage features were graded at 4 and 8 weeks.
RESULTS: In the observational pilot study, most participants showed improvement in overall photodamage, crow’s feet, elasticity,wrinkles, brightness, and hyperpigmentation at 60 to 80 days. Improvements at 60 to 80 days were greater than at 30 to 46 days. In the low-concentration study with 0.5% retinol, improvements were modest, most likely due to the lower retinol concentration. Burning, pruritus, dryness, and erythema were minimal with the 0.5% retinol concentration.
CONCLUSIONS: The topical formulation of 1% retinol improves photodamaged skin for at least 8 to 12 weeks. Although improvements with the 0.5% retinol were more modest, side effects such as burning, dryness, pruritus, and erythema during the 8-week study period were minimal. These encouraging results justify a longer-term study to determine whether topically applied 0.5% retinol can provide benefits comparable with those seen with topically applied 1% retinol.
J Drugs Dermatol. 2013;12(5):533-541.
Whitney P. Bowe MDa and Silvina Pugliese MDb| |
J Drugs Dermatol. 2014;13(9):1021-1025.
Leon H. Kircik MD| |
J Drugs Dermatol. 2014;13(4):466-470.
Julia Schwartz MDa and Adam J. Friedman MDa,b| |
Brighter Eyes: Combined Upper Cheek and Tear Trough Augmentation: A Systematic Approach Utilizing Two Complementary Hyaluronic Acid Fillers
J Drugs Dermatol. 2012;11(9):1094-1097.
Recommendations for the Best Possible Use of Botulinum Neurotoxin Type A (Speywood Units) for Aesthetic Applications
Berthold Rzany MD ScMa, Alina A.M. Fratila MDb, Tanja C. Fischer MDc, Said Hilton MDd, Tatjana Pavicic MDe, Alexander Rothhaar MDf, Gerhard Sattler MDg, Boris Sommer MDh,and Andy Pickett PhD BSci| |
J Drugs Dermatol. 2013;12(1):80-84.
Comparative Study of Hydroquinone-Free and Hydroquinone-Based Hyperpigmentation Regimens in Treating Facial Hyperpigmentation and Photoaging
Sabrina G. Fabi MD and Mitchel P. Goldman MD| |
OBJECTIVE: This investigator-blinded, randomized trial was conducted to compare a new hydroquinone (HQ)-free hyperpigmentation regimen against a leading HQ-based hyperpigmentation regimen for the treatment of facial hyperpigmentation and photoaging.
METHODS: Subjects with mottled pigmentation and photodamaged facial skin were randomized to treatment with either the new 4-product (HQ-free) SkinMedica® Hyperpigmentation System (SKM; SkinMedica, an Allergan Company, Carlsbad, CA) kit or the 7-product (HQ-containing) Obagi Nu-Derm System (OMP; Obagi Medical Products, Long Beach, CA) kit. Subjects were evaluated by a blinded investigator for clinical efficacy and tolerability using grading scales at baseline and at weeks 4, 8, and 12. Standardized digital photographs were taken at baseline and week 12. Self-assessment questionnaires were completed at week 12.
RESULTS: Thirty-six female subjects (16: SKM; 20: OMP) completed the 12-week comparative study. Both hyperpigmentation regimens significantly reduced Overall Hyperpigmentation, Mottled Pigmentation Area and Severity Index (MoPASI), global photoaging, and sallowness at week 12 compared to baseline. Significant reductions in tactile roughness were seen with the OMP regimen at week 12. In these investigator-blinded assessments, there were no significant differences between treatment groups, nor was there a difference in global response to treatment. Investigator assessments of tolerability showed mean scores were mild or below for all parameters with both treatment regimens.
CONCLUSION: A new 4-product (HQ-free) regimen was shown to be as effective and tolerable as a 7-product (HQ-based) regimen in reducing facial hyperpigmentation and photoaging in females with mottled pigmentation and photodamaged facial skin.
J Drugs Dermatol. 2013;12(3 suppl 1):s32-s37.
Sabrina Guillen Fabi MD,a Joel L. Cohen MD,b Jennifer D. Peterson MD,c Monika G. Kiripolsky MD,d and Mitchel P. Goldman MDa,e| |
OBJECTIVE: Evaluate the safety and efficacy of a topical antiphotoaging product containing secretions of the snail Cryptomphalus aspersa (SCA) for the improvement of facial rhytides.
MATERIALS and METHODS: This was a 2-center, double-blind, randomized, 14-week study in which 25 patients with moderate to severe facial photodamage were treated with an emulsion (with 8% SCA) and liquid serum (with 40% SCA) on one side of the face and placebo on the contralateral side for 12 weeks. Silicone skin impressions of periocular rhytides were performed at baseline and after 12 weeks of treatment. Patient and physician assessments were also performed at 8, 12, and 14 weeks.
RESULTS: Periocular rhytides on the active ingredient side showed significant improvement after 12 weeks (P=.03) and improved texture to a greater degree than placebo at 8 and 12 weeks, as well as 2 weeks after discontinuing the product (14 weeks).
CONCLUSION: Daily application of topical products containing SCA proved effective and well tolerated for improvement in coarse periocular rhytides and fine facial rhytides. Subjects noted a significant degree of improvement in fines lines at the 8-week time point on the SCA-treated side (P≤.05) but did not report a significant difference in the quality of their skin.
J Drugs Dermatol. 2013;12(4):453-457.
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.
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel for Rosacea: Summary of a Placebo-Controlled, Double-Blind Trial
J Drugs Dermatol. 2012;11(12):1410-1414.
Protective Effects of a Topical Antioxidant Complex Containing Vitamins C and E and Ferulic Acid Against Ultraviolet Irradiation-InducedPhotodamage in Chinese Women
Yan Wu MD PhD,a* Xin Zheng,a* Xue-Gang Xu MD,a Yuan-Hong Li MD PhD,a Bin Wang PhD,a Xing-Hua Gao MD PhD,a Hong-Duo Chen MD,a Margarita Yatskayer MS,b and Christian Oresajo PhDb,c| |
METHOD: Twelve healthy female Chinese subjects were enrolled in this study. Four unexposed sites on dorsal skin were marked for the experiment. The products containing antioxidant complex and vehicle were applied onto 2 sites, respectively, for 4 consecutive days. On day 4, the antioxidant complex-treated site, the vehicle-treated site, and the untreated site (positive control) received ssUVR (5 times the minimal erythema dose). The fourth site (negative control) received neither ssUVR nor treatment. Digital photographs were taken, and skin color was measured pre- and postirradiation. Skin biopsies were obtained 24 hours after exposure to ssUVR, for hematoxylin and eosin and immunohistochemical staining.
RESULTS: A single, 5 times the minimal erythema dose of ssUVR substantially induced large amounts of sunburn cell formation, thymine dimer formation, overexpression of p53 protein, and depletion of CD1a+ Langerhans cells. The antioxidant complex containing vitamins C and E and ferulic acid conferred significant protection against biological events compared with other irradiated sites.
CONCLUSION: A topical antioxidant complex containing vitamins C and E and ferulic acid has potential photoprotective effects against ssUVR-induced acute photodamage in human skin.
J Drugs Dermatol. 2013;12(4):464-468.
Aimee Krausz,a Holly Gunn MD,b and Adam Friedman MD FAADa,c| |
J Drugs Dermatol. 2014;13(8):937-943.
Eric F. Bernstein MD MSE,a Jay Bhawalkar PhD,b Joan Clifford MS,b James White,b James Hsia PhDb| |
Background: Due to the hemoglobin-selective wavelength of the 595 nm pulsed-dye laser, it is a device of choice for treating cutaneous
vascular lesions. However, it is less effective and removing dyschromia, which along with hypervascularity is a cardinal sign of cutaneous
photodamage. A novel 607 nm dye laser was developed as a first step in creating a dual-wavelength pulsed-dye laser.
Study Design/Materials and Methods: Twenty-five subjects with dyschromia on the chest due to chronic photodamage were enrolled into an open-label study to explore the safety and efficacy of a 607 nm pulsed-dye laser, with 22 completing the study. Two treatments were administered to the chest, one month apart, with fluences ranging from 3-6 J/cm,2 using a 10 mm diameter spot and pulse duration of 1.5 msec. Cross-polarized digital photographs were taken before and two months following the final treatment and rated for improvement by physicians in a blinded fashion.
Results: Improvement was rated on a five-point scale with no subjects rated as poor (<25%) clearance, three subjects (13.6%) demonstrating fair (26-50%) improvement, seven subjects (31.8%) rated as good (51-75%) improvement, 12 (54.5%) were rated as excellent (76-95%) improvement, while none were rated as outstanding improvement (>95%).
Conclusion: This is the first study of the 607 nm pulsed-dye laser which showed it to be safe and effective for treating dyschromia of the chest due to chronic photodamage, and may in the future expand the ability of the pulsed-dye laser to treat photodamaged skin.
J Drugs Dermatol. 2011;10(4):388-394.
J Drugs Dermatol. 2012;11(8):1000-1002.
Comparison Between 1% Tretinoin Peeling Versus 70% Glycolic Acid Peeling in the Treatment of Female Patients With Melasma
Gita Faghihi MD,a,b Anahita Shahingohar MD,a Amir Hossein Siadat MDa,b| |
Objective: The main purpose was to compare the efficiency and complications of GA 70% with Tretinoin 1% peeling.
Methods: A randomized, double-blinded clinical trial performed on 63 female patients with bilateral melasma. One facial side was treated by drug A (GA 70%) and the opposite side by agent B (Tretinoin 1%) peeling for four sessions with 2-week intervals. Descending changes in Melasma Area and Severity Index (MASI) scores, patients' discomfort and untoward complications following peeling all were evaluated and compared during the research period.
Results: The efficiency of Tretinoin 1% peelings in declining the MASI score (treatment of melasma) was similar to GA 70%, as well as the rare unwanted complications of them. However, the patients' discomfort following procedures as expressed by their own, was significantly lower with Tretinoin 1% compared to GA 70% peeling. The cases' satisfaction with the intervention was statistically similar to each other. Furthermore, we experienced almost the equal times of beginning the therapeutic responses in both groups.
J Drugs Dermatol. 2011;10(12):1439-1442.
Salicylic Acid 6% in an Ammonium Lactate Emollient Foam Vehicle in the Treatment of Mild-to-Moderate Scalp Psoriasis
Leon Kircik MD| |
J Drugs Dermatol. 2011;10(3):270-273.
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2015;14(suppl 10):s32-s34.
Improving Consent Procedures and Evaluation of Treatment Success in Cosmetic Use of IncobotulinumtoxinA: An Assessment of the Treat-to-Goal Approach
Ravi Jandhyala MSc(Lond) MBBS(Lond) MRCS(Glasg) MFPM| |
Objective: To evaluate the TTG approach vs standard consent procedures in terms of patient understanding of the risks and benefits of treatment.
Methods: This study was undertaken in 2 phases among consecutive patients presenting for BoNT-A treatment. Phase 1 consisted of a crossover comparison of patient satisfaction with standard consent vs the TTG approach (n=20). Patient understanding of the likely outcomes and risks associated with treatment following consent and their overall preference were assessed using 10-point visual analog scales (VAS). Phase 2 assigned patients to receive no treatment (n=10) or treatment with BoNT-A (n=54) following consent with the TTG approach. Patients were followed up with 28 days later to assess whether the goals defined during consent had been met.
Results: The TTG approach significantly improved patient understanding of likely outcomes of BoNT-A treatment compared with standard consent (P=.004 when standard consent assessed first, and P=.002 when TTG assessed first). All patients assessed preferred the TTG approach (median VAS score in favor of TTG: 7.0, P<.0001). Target improvements were successfully met or exceeded in at least one treatment area (forehead, glabellar lines, crow's feet) in all patients treated with BoNT-A. In contrast, none of the untreated patients met their target improvements unless the target was defined as no change.
Conclusion: The TTG approach represents a significant improvement over standard consent in terms of the information it provides to patients. Further investigation of this concept is warranted.
J Drugs Dermatol. 2013;12(1):72-78.
Evaluation of the Safety and Efficacy of a Low Fluence, Picopulsed, Alexandrite Laser in a Pico-Toning Technique With a Diffractive Lens Optic for the Treatment of Photodamage and Textural Improvement in “Off the Face” Applications
Raminder Saluja MD| |
J Drugs Dermatol. 2012;11(9):1059-1068.
Treatment of Moderate to Severe Acne Vulgaris in a Hispanic Population: A Post-Hoc Analysis of Efficacy and Tolerability of Clindamycin Phosphate 1.2%/Benzoyl Peroxide 2.5% Gel
Background: Acne in Hispanics is an increasing problem, presenting unique challenges. Although combination therapy is now a standard of care in acne, concerns exist with the increased potential irritation and dryness in this population and the potential for hyperpigmentation. There is a paucity of clinical studies that evaluate the efficacy and tolerability of acne medications in Hispanics.
Methods: A post-hoc analysis of efficacy and cutaneous tolerability in 458 Hispanic subjects receiving clindamycin phosphate 1.2%/BPO 2.5% gel, individual active ingredients and vehicle from two 12-week multicenter double-blind studies that enrolled 2813 subjects with moderate to severe acne.
Results: Median reductions in inflammatory lesions, noninflammatory, and total lesions (71.6%, 50.9% and 55.1%, respectively) were significantly greater with clindamycin phosphate 1.2%/BPO 2.5% gel versus the individual active ingredients and vehicle. Treatment success (35.6% "clear/almost clear") and patient satisfaction (83.2%) were also significantly greater than vehicle at week 12. Cutaneous tolerability was excellent with all mean scores less than or equal to 0.2 at week 12 (where 1=mild).
Conclusions: Overall efficacy and tolerability with clindamycin phosphate 1.2%/BPO 2.5% gel were better in the Hispanic population compared to the total study population. Hispanic acne subjects were not found to be more susceptible to cutaneous irritation from treatment with clindamycin phosphate 1.2%/BPO 2.5% gel and both efficacy and tolerability was excellent. J Drugs Dermatol.
J Drugs Dermatol. 2012;11(4):455-459.
The Emervel French Survey: A Prospective Real-Practice Descriptive Study of 1,822 Patients Treated for Facial Rejuvenation With a New Hyaluronic Acid Filler
David Farhi MD,a,b Patrick Trevidic MD,c Philippe Kestemont MD,d Dominique Boineau MD,e
Hugues Cartier MD,f Isaac Bodokh MD,g Patrick Brun MD,g Benjamin Ascher MD,h
and Jacques Savary MD,b,i for the Emervel French Survey Group
OBJECTIVES: To describe the current use of Emervel fillers in France.
METHODS: Prospective multicenter, cross-sectional, real-practice, descriptive survey, including 1,822 patients injected with Emervel fillers for face rejuvenation by 58 French physicians between September 2010 and July 2011. The injection modalities were left to the respective physician’s discretion.
RESULTS: The physicians were dermatologists (52.3%), surgeons (43.8%), or general practitioners (14.1%). Nasolabial folds (NLF) with a mean severity 2.4 were mainly injected with Emervel Deep (51.0%) and Emervel Classic (36.0%) (mean volume: 1.0 mL), and primarily with the linear retrograde (LR) technique (89.3%). Marionette lines (ML), with a mean severity 2.6 were mainly injected with Emervel Deep (52.5%) and Emervel Classic (34.6%) (mean volume: 0.8 mL), and mainly with the LR technique (79.5%). More than 90% of patients had scores of 0 or 1 for erythema, bruising, edema, and pain. No serious adverse events were reported up to 15 months after the injection.
CONCLUSION: These data could contribute to upcoming international consensus on optimal injection modalities of the Emervel range of HA fillers.
J Drugs Dermatol. 2013;12(5):e88-e93.
Efficacy and Safety of IncobotulinumtoxinA in Asian Subjects: A Pooled Analysis of Clinical Trials in the Treatment of Glabellar Frown Lines
Kyle Seo MD PhD,a,b Tsen-Fang Tsai MD,c Yates Yen-Yu Chao MD,d Greg J. Goodman FACDe,f| |
METHODS: Efficacy data were pooled from several Phase II/III trials that used 20 U incobotulinumtoxinA to treat glabellar frown lines in Asian subjects. The variable of interest was investigator-assessed improvement in scores on the 4-point Facial Wrinkle Scale from baseline to days 30, 60, 90, and 120. Subjects with a 1-point improvement were considered ‘responders’. Data were also assessed for treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest among a pool of incobotulinumtoxinA safety studies.
RESULTS: Four trials were pooled, comprising 19 Asian and 563 non-Asian subjects. At maximum frown on day 30, 100% of Asians and 87% of non-Asians were responders; by day 120, values were 37% and 40%, respectively. At rest on day 30, 63% of Asians and 56% of non-Asians were responders. Corresponding values for day 120 were 11% and 25%. The mean change in score on the Facial Wrinkle Scale from baseline over time was similar in both groups. Very few adverse events occurred. Overall, treatment-emergent adverse events were lower amongst Asians than non-Asians.
CONCLUSIONS: Compared with non-Asians, a trend towards slightly higher responses was observed in Asians at maximum frown. There were no clinically relevant differences in the safety of incobotulinumtoxinA when administered to Asian and non-Asian subjects.
J Drugs Dermatol. 2016;15(9):1084-1087.
Braden McKnight BS,a Rachel Tobin BS,b Yasmeen Kabir MD,c and Ronald Moy MDa| |
METHODS & MATERIALS: Twelve females received eight weekly non-ablative treatments using a tripolar radiofrequency device on the anterior and posterior upper arms. Evaluations included body weight, photographs, and circumference measurements at baseline and each subsequent week throughout the 8-week time period. The subjects and the investigator completed evaluations of clinical improvement using a 5-point assessment scale.
RESULTS: A significant circumference reduction was achieved in each arm of all twelve patients. A mean reduction of 1.99 ± 0.94 cm (P=0.001) was observed between the initial and final measurements after the 8-week treatment period. At the 4-week follow up, the average circumferential reductions of the posterior and anterior upper arms were sustained. Patient evaluations indicated moderate to good improvement of size, tightness, and overall appearance. The procedure was well tolerated without pain.
CONCLUSION: Tripolar radiofrequency devices offer a safe and effective non-invasive technology with beneficial effects on the circumferential reduction and overall appearance of the posterior and anterior upper arms.
J Drugs Dermatol. 2015;14(12):1463-1466.
Development and Clinical Assessment of a Comprehensive Product for Pigmentation Control in Multiple Ethnic Populations
Elizabeth T. Makino BS CCRA MBA,a Kuniko Kadoya PhD,a Monya L. Sigler PhD,b Peter D. Hino MD FAAD,b and Rahul C. Mehta PhDa| |
Comparison of Clindamycin 1% and Benzoyl Peroxide 5% Gel to a Novel Composition Containing Salicylic Acid, Capryloyl Salicylic Acid, HEPES, Glycolic Acid, Citric Acid, and Dioic Acid in the Treatment of Acne Vulgaris
Leslie S. Baumann MD, CPI,a Kristian Figueras MS,a Amanda Dahl BS CCRA,b Margarita Yatskayer MS,b and Christian Oresajo PhDb| |
J Drugs Dermatol. 2013;12(3):266-269.
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.
Current Understanding of Seborrheic Keratosis: Prevalence, Etiology, Clinical Presentation, Diagnosis, and Management
J. Mark Jackson MD FAAD,a Andrew Alexis FAAD MPH FAAD,b Brian Berman MD PhD FAAD,c Diane S. Berson MD FAAD,d Susan Taylor MD FAAD,e Jonathan S. Weiss MD FAADf| |
J Drugs Dermatol. 2015;14(10):1119-1125.
Annie Chiu MD,a Sabrina Fabi MD,b Steven Dayan MD,c and Alessandra Nogueira MDd| |
J Drugs Dermatol. 2016;15(9):1076-1082.
Adjunctive Use of a Facial Moisturizer SPF 30 Containing Ceramide Precursor Improves Tolerability of Topical Tretinoin 0.05%: A Randomized, Investigator-Blinded, Split-Face Study
Methods:This was a randomized, investigator/evaluator-blinded, split-face comparison in subjects with healthy skin. Subjects applied tretinoin cream 0.05% once daily to the whole face and Cetaphil® Dermacontrol Moisturizer (CDM) once daily to one side of the face based on randomization. Tolerability, perference and skin hydration were evaluated at each week, and a cosmetic acceptability questionnaire regarding CDM was completed at the end of the study.
Results: The majority (about 83% to 86%) of subjects experienced skin irritations on both sides of their face, though predominantly mild for the CDM + tretinoin treated side. Tolerability preferences favored the CDM+tretinoin sides. Adjunctive use of CDM with a topical tretinoin cream improves tolerance of the treatment.
J Drugs Dermatol. 2012;11(9):1104-1107.
Shlomit Halachmi, MD PhD,a Dan Ben Amitai MD,b,d and Moshe Lapidoth MD MPHc,d| |
MATERIALS and METHODS: Twelve consecutive patients with moderate to severe acne scarring, who had completed a series of fractional laser resurfacing, underwent microinjections of 20 mg/mL hyaluronic acid (HA) gel into discrete depressed acne scars on the face.
RESULTS: Immediate visual improvement was observed in all lesions. The procedure was well tolerated. Adverse events were limited to transient pinpoint bleeding at the injection site.
CONCLUSION: Microinjection of low viscosity HA offers a valuable technique for the treatment of discrete depressed acne scars.
J Drugs Dermatol. 2013;12(7):e121-e123.
Maritza Perez MD, Janiene Luke MD, Anthony Rossi MD| |
Melasma is an acquired skin condition characterized by irregular brown or hyperpigmented patches typically located on the forehead, cheeks, nose, chin and upper lip. The pathogenesis of melasma is not completely understood, but is thought to be influenced by genetics, UV exposure, thyroid dysfunction and hormonal influences from either pregnancy or hormonal therapeutic medications. Peoples of Latin descent comprise a vast array of skin colors and skin phototypes. Similarly, disorders of pigmentation, particularly melasma, occur more frequently in people of Latin descent when compared to the general population. Melasma can be particularly distressing to patients and has been shown to impact a patient's quality of life in several studies. These factors can raise significant quality of life issues and therefore treatment is not only significant for improving patient clinical outcomes, but is crucial in improving important psychological and emotional aspects of patients' overall well being. This article provides a stepwise approach to the treatment of melasma based on current literature recommendations.
J Drugs Dermatol. 2011;10(5):517-523.
Selective Radiofrequency Therapy as a Non-Invasive Approach for Contactless Body Contouring and Circumferential Reduction
Kateřina Fajkošová MUDr,a Alena Machovcová MD PhD MBA,b,c Meltem Onder MD,d and Klaus Fritz MDd,e| |
J Drugs Dermatol. 2014;13(3):291-296.
Long-Term Safety and Efficacy of Once-Daily Topical Brimonidine Tartrate Gel 0.5% for the Treatment of Moderate to Severe Facial Erythema of Rosacea: Results of a 1-Year Open-Label Study
Angela Moore MD,a Steven Kempers MD,b George Murakawa MD,c Jonathan Weiss MD,d Amanda Tauscher MD,e Leonard Swinyer MD,f Hong Liu MSc,g and Matthew Leoni MDg on behalf of the Brimonidine LTS Study Group| |
J Drugs Dermatol. 2014;13(1):56-61.
J Drugs Dermatol. 2012;11(6):731-736.
The Frontalis Activity Measurement Standard: A Novel Contralateral Method for Assessing Botulinum Neurotoxin Type-A Activity
Background: There are conflicting data regarding the specific attributes of botulinum neurotoxin type-A (BoNTA) products including onset of action, duration and spread because accurate, objective methods for assessing their clinical activity are lacking.
Objective: To refine definitions for BoNTA activity utilizing the frontalis muscle and describe the Frontalis Activity Measurement Standard (FMS), an objective method for measuring changes in frontalis muscle activity as a metric for assessing BoNTA pharmacodynamics.
Methods: As part of a study to assess BoNTA activity, 20 subjects with severe frontalis lines at maximum elevation were injected with two BoNTA products at five points on contralateral sides of the frontalis. Changes in maximum baseline frontalis elevation were measured by a blinded investigator using the previously-validated Frontalis Rating Scale (FRS) and the FMS. Frontalis activity endpoints were redefined to include Initial, Full and Complete Onsets of action and Partial, Full and Complete efficacy.
Results: Differences in the onset of effect of the BoNTA products were detected with both the FRS and FMS; however, the FMS detected changes in frontalis activity earlier than the FRS. A significant correlation between the FRS and FMS was documented.
Conclusion:The frontalis muscle activity allows for enhanced assessment of BoNTA activity and attributes. The FMS appears to be a sensitive and objective tool for measuring pharmacodynamic parameters of BoNTA. Refining definitions of BoNTA activity provides a more accurate means for describing the clinical effects of BoNTA.
J Drugs Dermatol. 2011;10(9):968-972.
Martina Kerscher MD,a Yana Yutskovskaya MD,b and Timothy Corcoran Flynn MDc| |
J Drugs Dermatol. 2013;12(6):e111-e120.
Hilary E. Baldwin MD,a Marge Nighland BS,b Clare Kendall MA,c David A. Mays PharmD MBA,c Rachel Grossman MD,b,c and Joan Newburger PhDc| |
J Drugs Dermatol. 2013;12(6):638-642, e94-e105.
Z. Paul Lorenc MD FACS,a Thomas Greene MD,b and Ronald W. Gottschalk MD FAAD FRCPCc| |
J Drugs Dermatol. 2016;15(6):759-762.
Nils Krueger PhD,a Stefanie Luebberding MSc,a Gerhard Sattler MD,b C. William Hanke MD,c
Macrene Alexiades-Armenakas MD,d and Neil Sadick MDe
J Drugs Dermatol. 2013;12(7):737-742.
Tuyet A. Nguyen BA BS and Adam J. Friedman MD| |
J Drugs Dermatol. 2013;12(10):1131-1137.
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.
J Drugs Dermatol. 2012;11(11):1316-1230.
Cosmetic Use of AbobotulinumtoxinA in Men: Considerations Regarding Anatomical Differences and Product Characteristics
Jason D. Bloom MD,a Jeremy B. Green MD FAAD,b Whitney Bowe MD,c Erika von Grote PhD,d and Alessandra Nogueira MDd| |
Among the product options available in the US, Dysport® (abobotulinumtoxinA) (Galderma Laboratories, L.P., Fort Worth, Texas) is unique in that its recommendations for reconstitution provide the clinician with 2 different final product concentrations. The flexibility provided by a variable dose may be a valuable tool for tailoring treatments to male patient-specific needs, which may include a more conservative outcome, maintaining a certain degree of muscle activity and expressivity. Achieving a conservative outcome may be the key to a positive experience for the male patient.
J Drugs Dermatol. 2016;15(9):1056-1062.
Assessing Improvement of Facial Appearance and Quality of Life after Minimally-Invasive Cosmetic Dermatology Procedures Using the FACE-Q Scales
Brian P. Hibler BS, Jonathan Schwitzer MD, and Anthony M. Rossi MD| |
OBJECTIVE: We sought to determine the impact of laser resurfacing and injectable treatment (neurotoxin or fillers) on patient perceived improvement in facial appearance.
METHODS and MATERIALS: Patients were asked to complete FACE-Q scales (Satisfaction with Facial Appearance, Satisfaction with Facial Skin, and Appraisal of Facial Lines) at their pre-procedure consultation and/or at post-procedural follow-up. Item means (range 1-4) and Rasch transformed scores (range 0-100) were compared pre to post-procedure using two sample t-tests. Higher FACE-Q scores indicated greater satisfaction.
RESULTS: Overall, patients experienced a statistically significant improvement in all three scales pre- to post-procedure (P <0.05). Sub-group analysis showed statistically significant improvement in Satisfaction with Facial Appearance and Satisfaction with Facial Skin for both the laser resurfacing group and injectables group with moderate effect sizes. Improvement on Appraisal of Facial Lines trended toward improvement but did not reach statistical significance.
CONCLUSION: Our results support the ability to directly measure and quantify meaningful improvement in appearance among facial cosmetic dermatology patients using FACE-Q scales. Reporting this data is important, as this is the first step towards evidence-based cosmetic procedures in dermatology.
J Drugs Dermatol. 2016;15(1):62-67.
Eric F. Bernstein MD| |
Study Design: A total of twenty subjects with chronic photodamage were enrolled in this study. Subjects received a maximum of four full-face treatments at an average fluence of 9.5 J/cm2 at 1,320 nm and 2 J/cm2 at 1,450 nm, delivered sequentially using forced-air cooling, at monthly intervals. Digital photographs were taken two months following the final treatment and compared to pre-treatment photographs by two blinded physician observers.
Results: Improvement in photodamage, overall appearance, wrinkles, hyper-pigmentation, enlarged pores, and sagging skin was rated by blinded physician evaluation of digital photographs as being in the 25-50 percent range. Subjective ratings averaged improved for all criteria that were evaluated, including wrinkles, enlarged pores, redness, sagging skin and hyper-pigmentation.
Conclusions: The multiplexed 1,320 nm and 1,440 nm fractionated laser improves cuta/neous photodamage as assessed by objective and subjective criteria.
J Drugs Dermatol. 2011;10(11):1266-1270.
Hervé Raspaldo MD,a Jonquille Chantrey MD,b Lakhdar Belhaouari MD,c David Eccleston MD,d Roy Saleh MD,e Raj Acquilla MD,f and Diane K. Murphy MBAg| |
OBJECTIVE: Evaluate the safety and effectiveness of Juvéderm Volbella with Lidocaine versus non-animal stabilized hyaluronic acid with lidocaine (Restylane-L®).
METHODS: This study randomized 280 subjects desiring lip enhancement to Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated outcomes using Allergan’s Lip Fullness Scale (LFS), Perioral Lines Severity Scale, and Oral Commissures Severity Scale. Independent central reviewers (ICRs) assessed 3-dimensional photographs using these scales. Noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L was based on ICR assessment of LFS responders (≥1-point improvement from baseline) at month 3. Subjects were evaluated up to 12 months and after repeat treatment.
RESULTS: Juvéderm Volbella with Lidocaine was noninferior to Restylane-L at 3 months. Investigator assessments showed significant improvements in lip fullness (P≤.03), perioral lines (P≤.04), and oral commissures (P≤.03) with Juvéderm Volbella with Lidocaine versus Restylane-L at months 6 to 12. There was less acute swelling and fewer severe injection site responses with Juvéderm Volbella with Lidocaine. Safety and effectiveness of repeat treatment with Juvéderm Volbella with Lidocaine was comparable to initial treatment, regardless of initial filler.
CONCLUSIONS: Juvéderm Volbella with Lidocaine is safe and effective for lip and perioral enhancement, with effectiveness lasting up to 12 months.
J Drugs Dermatol. 2015;14(12):1444-1452.
Introduction: This study evaluated the efficacy and tolerability of treating mild-to-moderate facial acne using a new, hand-held,
light-emitting diode blue light device in conjunction with a foam cleanser containing 5% glycolic acid and 2% salicylic acid plus a skin
rebuilding serum containing 1.25% salicylic acid, 0.5% niacinamide, 0.08% liposomal-based azelaic acid and superoxide dismutase.
Methods: Volunteers with mild-to-moderate facial inflammatory acne used the blue light device twice daily for eight weeks, plus the cleanser before treatments and the serum after each evening treatment.
Results: Among 33 subjects aged 25–45 years old, 28 completed. In a 3 cm x 5 cm target area receiving a daily dose of ~29 J/cm2, treatment was associated with significant reductions from baseline in the inflammatory lesion count from week 1 onward (P≤.01) and in the non-inflammatory lesion count from week 4 onward (P≤.05). The number of flares was significantly reduced from baseline from week 2 onward (P≤.05), and flare severity and flare redness were significantly reduced from baseline from week 4 onward (P≤.01 and P≤.05, respectively). At week 8, more than 90 percent of subjects reported improvements in their skin’s overall appearance, clarity, radiance, tone, texture and smoothness. In addition, 82 percent were satisfied, very satisfied, or extremely satisfied with the blue light treatment system and 86 percent agreed the treatment system was much gentler than traditional acne treatments.
Conclusion: The blue light treatment system offers effective, rapid, convenient and well tolerated treatment of inflammatory and non-inflammatory acne lesions. The majority of subjects consider it much gentler than traditional acne treatments and it facilitates effective treatment without the need for antibiotic exposure. The blue light treatment system and blue light therapy alone are attractive treatment options for acne vulgaris, both as alternatives to traditional acne treatments and as adjunctive treatments to complement existing therapies.
J Drugs Dermatol. 2011;10(6):596-602.
Split-Face Comparison of Ultrapulse-Mode and Superpulse- Mode Fractionated Carbon Dioxide Lasers on Photoaged Skin
Background: Both ultrapulse-mode and superpulse-mode fractional CO2 lasers (UPCO2 and SPCO2) could be successfully used
in treating photoaged skin.
Objective: This evidence-based study was intended to compare the therapeutic and adverse effects of UPCO2 and SPCO2 in treating photoaged skin in Chinese subjects.
Methods: Eighteen Chinese subjects with Fitzpatrick skin type IV were enrolled in a randomized, split-face trial. Subjects received SPCO2 on one half of the face and UPCO2 on the other half. Before and after photos, skin color, epidermal water content, sebum level, periorbital wrinkles, skin roughness, and self-esteem questionnaires were used.
Results: Global evaluation and subjects' self-esteem assessments showed a similar trend at 1-month and 3-month follow-up visits on both sides. The UPCO2 laser has a shorter downtime of 6.25±2.71 days compared with 6.41±2.67 days for SPCO2, but has a higher incidence of edema, spot bleeding, prolonged redness and postinflammatory hyperpigmentation. More subjects prefer SPCO2 treatment because of similar efficacy and fewer adverse effects.
Conclusion: The effectiveness of the SPCO2 laser in treating photoaged skin is very similar to the UPCO2 laser, with less erythema, but more crusting and longer downtime.
J Drugs Dermatol. 2012;11(11):1310-1314
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.
Clinical Equivalence of Conventional OnabotulinumtoxinA (900 KDa) and IncobotulinumtoxinA (Neurotoxin Free From Complexing Proteins - 150 KDa): 2013 Multidisciplinary French Consensus in Aesthetics
Bernard Poulain PhD,a Patrick Trevidic MD,b Micheline Clavé MD,c Claude Aharoni MD,d Martine
Baspeyras MD,e Patrick Bui MD,f Hugues Cartier MD,g Marie-Hélène Charavel MD,h Pierre Coulon MD,i
Serge Dahan MD,j Jean-Marie Dallara MD,k Denis Delonca MD,l Laurent Dumas MD,m
Eric Essayagh MD,n Olivier Galatoire MD,o Nicolas Georgieu MD,p Yann Grangier MD,q
Philippe Humbert PhD,r Anne Le Pillouer-Prost MD,s and Alain Mojallal MDt
J Drugs Dermatol. 2013;12(12):1434-1446.
Patient Reported Outcomes from HIV Facial Lipoatrophy Treatment With a Volumizing Hyaluronic Acid Filler: A Prospective, Open-Label, Phase I and II Study
Derek Ho BSa,b and Jared Jagdeo MD MSa,b,c| |
OBJECTIVE: To provide patient reported outcomes from HA filler for treatment of HIV FLA and suggest recommendations on use of validated QOL outcome measures to assess patient concerns specific to HIV FLA.
METHODS: This was a prospective, open-label, phase I and II study to evaluate patient reported outcomes, in addition to safety and efficacy, of this HA filler for treatment of HIV FLA in 20 subjects at the Sacramento Veterans Affairs Medical Center, Mather, CA (ClinicalTrials.gov NCT02342223). Outcome measures include the Dermatology Life Quality Index (DLQI) and a subject satisfaction questionnaire (SSQ).
RESULTS: Nineteen subjects completed the 12-month follow-up. There was no significant improvement of DLQI score. Subject comments revealed high degree of satisfaction and there were no negative comments on the SSQ.
CONCLUSIONS: In this study, we report that all subjects that completed this study were satisfied and had subjective improvement of their QOL post-treatment. We recommend against use of DLQI in the future as it may not fully encompass the emotional and mental health aspects that may be affected from HIV FLA. We recommend use of the Facial Appearance Inventory (FAI) and FACE-Q in future studies for HA filler treatment of HIV FLA.
J Drugs Dermatol. 2016;15(9):1064-1069.
Kristin K. Marcum MD,a Neal D. Goldman MD,c and Laura F. Sandoval DOb| |
OBJECTIVE: To use various methods of photography including standard photography, cross polarized light, parallel polarized light and ultraviolet passing photography to assess which method most effectively captures skin features such as texture, pigment, and/ or vascularity.
METHODS: A prospective analysis comparing advanced photographic techniques including standard photography, polarized light photography, cross-polarized light photography and ultraviolet light passing photography. The photos were then evaluated and scored by two experts and a blinded observer to characterize the differences visualized in each type of photography compared to standard photography in terms of subsurface skin features, hypopigmentation, hyperpigmentation, and rhytids.
RESULTS: 9 subjects completed the study. Overall, of the 3 photographic methods compared to standard photography, UV passing most enhanced the visualization of subsurface features and hypopigmentation, with increased hyperpigmentation as well. Enhancement of these features made UV passing best for capturing photodamage. Cross-polarized photography was best for visualizing hyperpigmentation, but also heightened visualization of hypopigmentation and subsurface features such as vascularity. Parallel-polarized photography enhanced visualization of skin texture.
CONCLUSIONS: These methods of photography show a quantifiable and reproducible selective ability to evaluate and document elements such as skin texture, vascularity, and pigmentation. Each of these techniques has unique properties that can add to the precision of the clinical evaluation and can be of particular value to providers of cosmetic procedures where photo documentation has become increasingly important in providing an objective means of evaluating outcomes.
J Drugs Dermatol. 2015;14(2):134-139.
Evaluation of Moisturizing Effect of Methanolic Extract of Five Medicinal Plants Incorporated Into Cream Bases Using Impedance and Extensiometry Methods
Background: Skin moisturizing is an important issue due to its impact on skin function. Adverse reactions to herbal extracts have been rarely reported and can be used in moisturizers. This study was conduct to evaluate moisturizing effect of a methanolic extract of five medicinal plants incorporated into cream bases.
Methods: Methanolic extract of five medicinal plants including olive, burdock, licorice, mallow and marsh horsetail was prepared. The extracts were dissolved in distilled water completely and freeze-dried to a dry powder. These extracts were added separately to the cream based formulation that has been suggested to be appropriate for adding herbal extracts. Moisturizing effects of these creams with herbal extracts were assessed using the impedance method on 12 rats equally divided into six groups (one control and five cases), as well as the extensiometry method on 25 mice divided into five groups (in each group one cream with herbal extract and control cream were tested concurrently). Obtained results were compared with the control cream based.
Results: The maximum moisturizing effect was observed with the marsh horsetail. Other creams with herbal extracts, except the one with the licorice, also exerted significantly higher moisturizing effect compared to the controls (P<0.05). Regarding the force for skin tearing, the differences were statistically significant in all groups when compared to the control group (P<0.05) and the highest difference was seen in the marsh horsetail group (2.0832 ± 0.6811 kgN).
Conclusions: The highest moisturizing activity was observed using marsh horsetail extract that can be explained by flavonoids content of marsh horsetail.
J Drugs Dermatol. 2011;10(10):1116-1121.
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.
Efficacy and Safety of Once-Daily Topical Brimonidine Tartrate Gel 0.5% for the Treatment of Moderate to Severe Facial Erythema of Rosacea: Results of Two Randomized, Double-blind, and Vehicle-Controlled Pivotal Studies
Joseph Fowler Jr. MD,a J. Mark Jackson MD,a Angela Moore MD,b Michael Jarratt MD,c Terry Jones MD,d Kappa Meadows MD,e Martin Steinhoff MD,f Diane Rudisill BSc,g and Matthew Leoni MDg on behalf of the Brimonidine Phase III Study Group| |
OBJECTIVE: To assess the efficacy and safety of topical brimonidine tartrate gel 0.5% for the treatment of erythema of rosacea.
METHODS: Both studies were randomized, double-blind, and vehicle-controlled, with identical design. Subjects with moderate to severe erythema of rosacea were randomized 1:1 to apply topical brimonidine tartrate gel 0.5% or vehicle gel once-daily for 4 weeks, followed by a 4-week follow-up phase. Evaluations included severity of erythema based on Clinician’s Erythema Assessment and Patient’s Self-Assessment, as well as adverse events.
RESULTS: Topical brimonidine tartrate gel 0.5% was significantly more efficacious than vehicle gel throughout 12 hours on days 1, 15, and 29, with significant difference observed as early as 30 minutes after the first application on day 1 (all P<.001). No tachyphylaxis, rebound or aggravation of other disease signs were observed. Slightly higher incidence of adverse events was observed for topical brimonidine tartrate gel 0.5% than for vehicle; however, most of the adverse events were dermatological, mild, and transient in nature.
LIMITATIONS: These data generated in controlled trials may be different from those in clinical practice.
CONCLUSIONS: Once-daily brimonidine tartrate gel 0.5% has a good safety profile and provides significantly greater efficacy relative to vehicle gel for the treatment of moderate to severe erythema of rosacea, as early as 30 minutes after application.
J Drugs Dermatol. 2013;12(6):650-656.
Evaluation of a Low Energy, Low Density, Non-Ablative Fractional 1927nm Wavelength Laser for Facial Skin Resurfacing
Jeremy A. Brauer MD,a,b Hamad Alabdulrazzaq MBChB,a Yoon-Soo Cindy Bae MD,a,b
and Roy G. Geronemus MDa,b
DESIGN: Prospective non-randomized trial.
SETTING: Single center, private practice with a dedicated research department.
PARTICIPANTS: Subjects with clinically diagnosed facial photodamage, melasma, or post inflammatory hyperpigmentation
INTERVENTIONS: Subjects received four to six treatments at 14-day intervals (+/- 3days) with a low energy low density non-ablative fractional 1,927-nm laser (Solta Hayward, CA) with an energy level of 5 mJ, and density coverage of either 5%, 7.5%, or 10%, with a total of up to 8 passes.
MAIN OUTCOME AND MEASURES: Blinded assessment of clinical photos for overall improvement at one and three months post final treatment. Investigator improvement scores, and subject pain and satisfaction scores for overall improvement were recorded as well.
RESULTS: We enrolled 23 subjects, average age 45.0 years (range, 25-64 years), 22 with Fitzpatrick Skin Types I-IV and 1 with Type VI, with facial photodamage, melasma, or post inflammatory hyperpigmentation. Approximately 55% of subjects reported marked to very significant improvement at one and three months post final treatment. Blinded assessment of photography of 20 subjects revealed an average of moderate improvement at one-month follow up and mild to moderate improvement at three months. Average subject pain score was 3.4/10 during treatment.
CONCLUSIONS AND RELEVANCE: Favorable outcomes were demonstrated using the low energy low density, non-ablative fractional 1,927-nm laser in facial resurfacing for photodamage, melasma, and post inflammatory hyperpigmentation. Results were maintained at the 3-month follow up, as demonstrated by investigator and subject assessments, as well as blinded evaluations by three independent dermatologists utilizing photographs obtained from a standardized facial imaging device.
J Drugs Dermatol. 2015;14(11):1262-1267.
Comparative Effects of Sunscreens Alone vs Sunscreens Plus DNA Repair Enzymes in Patients With Actinic Keratosis: Clinical and Molecular Findings from a 6-Month, Randomized, Clinical Study
Mauro Carducci MD,a Paolo Sergio Pavone MD,b Giuseppe De Marco MD,a Silvia Lovati MD,b
Velimir Altabas MD,d Karmela Altabas MD,d and Enzo Emanuele MDc
J Drugs Dermatol. 2015;14(9):986-990.
Effect of Different Crosslinking Technologies on Hyaluronic Acid Behavior: A Visual and Microscopic Study of Seven Hyaluronic Acid Gels
Patrick Micheels MD,a Didier Sarazin MD,b Christian Tran MD,c and Denis Salomon MDd| |
OBJECTIVE: To examine the different properties of a range of HA gels using simple and easily reproducible laboratory tests to better understand their suitability for particular indications.
METHODS AND MATERIALS: Hyaluronic acid gels produced by one of 7 different crosslinking technologies were subjected to tests for cohesivity, resistance to stretch, and microscopic examination. These 7 gels were: non-animal stabilized HA (NASHA® [Restylane®]), 3D Matrix (Surgiderm® 24 XP), cohesive polydensified matrix (CPM® [Belotero® Balance]), interpenetrating network-like (IPN-like [Stylage® M]), Vycross® (Juvéderm Volbella®), optimal balance technology (OBT® [Emervel Classic]), and resilient HA (RHA® [Teosyal Global Action]).
RESULTS: Cohesivity varied for the 7 gels, with NASHA being the least cohesive and CPM the most cohesive. The remaining gels could be described as partially cohesive. The resistance to stretch test confirmed the cohesivity findings, with CPM having the greatest resistance. Light microscopy of the 7 gels revealed HA particles of varying size and distribution. CPM was the only gel to have no particles visible at a microscopic level.
CONCLUSION: Hyaluronic acid gels are produced with a range of different crosslinking technologies. Simple laboratory tests show how these can influence a gel’s behavior, and can help physicians select the optimal product for a specific treatment indication.
Versions of this paper have been previously published in French and in Dutch in the Belgian journal Dermatologie Actualité. Micheels P, Sarazin D, Tran C, Salomon D. Un gel d’acide hyaluronique est-il semblable à son concurrent? Derm-Actu. 2015;14:38-43.
J Drugs Dermatol. 2016;15(5):600-606.
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.
Noelani Gonzalez MD and Maritza Perez MD| |
J Drugs Dermatol. 2016;15(1):26-34.
Lee Miller MD,1 Vineet Mishra MD,1 Salman Alsaad MD,1 Doug Winstanley MD,1 Travis Blalock MD,1
Chad Tingey MD,1 Jinze Qiu PhD,2 Sara Romine,1 E. Victor Ross MD1
MATERIALS AND METHODS: Under an IRB approved study, eleven subjects with facial photodamage (1 male and 10 female) were enrolled and completed the study. The fractional 1940 nm laser was comprised of a thulium rod pumped by a pulsed alexandrite laser. The fractional patterns were generated by four separate handpieces (two dot (0.48mm and 0.76mm dot-to-dot distance or pitch) and two grid geometries) whereby a larger beam was broken up into smaller microbeams by a microlens system or reflective square grids. The low -pitch circular dot array handpiece, which is used most frequently, has a macro-spot size of 12 mm and a total applied energy of approximately 2-5 J (~ 4-10 mJ per beamlet). Contact skin cooling (5-20degC) was provided via a sapphire window at the distal end of handpiece. Pulses from the dot handpieces were applied with 20% overlap. The microspot size for the dot handpieces was ~ 0.2-0.3 mm. The two grid pattern handpieces included 0.4 mm wide lines with 45% and 0.7 mm wide lines with 65% coverage. Each subject received 3 full-face treatments 4-6 weeks apart. Anesthesia was achieved by 5% lidocaine cream and a cold air chiller. Typical treatments were carried out with two passes. Outcome assessments included changes in pigment, rhytides, laxity, elastosis, and texture, using a diffuse pigmentation scale and the Alexiades-Armenakas Comprehensive Grading Scale of Rhytides, Laxity, and Photodamage. Photographs of each patient from prior to treatment, and 3 months after treatment were analyzed by 3 blinded physician raters. A paired t-test was applied for each category comparing the pre treatment and 3-month post treatment results.
RESULTS: Three months after the final treatment, (a) mean pigment improvement was 21.1%, (b) rhytides were reduced by 14.3%, (c) laxity was reduced by 8.9%, elastosis was reduced by 22.3%, and (e) texture scores were unchanged. Reductions in pigmentation, rhytides, and elastosis were statistically significant (P ≤ 0.05). Clinical downtime was 3-5 days. Pain was variable (mean of 2.8/10) and side effects included two cases of mild focal vesiculation. No long-term side effects were noted. Histological analysis showed focal damage that extended about 200 μm deep to the surface.
CONCLUSION: The 1940nm thulium laser is safe, well tolerated, and results in reduced downtime compared to traditional resurfacing. The study demonstrated that the 1940 nm thulium laser could achieve injury patterns capable of skin rejuvenation.
J Drugs Dermatol. 2014;13(11):1324-1329.
A Phase I Safety and Pharmacokinetic Study of ATX-101: Injectable, Synthetic Deoxycholic Acid for Submental Contouring
Patricia Walker MD PhD,a,b Jere Fellmann PhD,b and Paul F. Lizzul MD PhD MBA MPHb| |
J Drugs Dermatol. 2015;14(3):279-284.
Amy Forman Taub MDa,b and Ann Cameron Schieber PA-Ca| |
J Drugs Dermatol. 2015;14(11):1329-1334.
Rebecca Kleinerman MD, Thomas H. King MD, and Daniel B. Eisen MD| |
J Drugs Dermatol. 2013;12(1):60-65.
Objective: The objective of this study was to determine the role of immunity and inflammation in androgenetic alopecia in women and modulate therapy according to inflammatory and immunoreactant profiles.
Materials and Methods: 52 women with androgenetic alopecia (AA) underwent scalp biopsies for routine light microscopic assessment and direct immunofluroescent studies. In 18 patients, serologic assessment for antibodies to androgen receptor, estrogen receptor and cytokeratin 15 was conducted.
Results: A lymphocytic folliculitis targeting the bulge epithelium was observed in many cases. Thirty-three of 52 female patients had significant deposits of IgM within the epidermal basement membrane zone typically accompanied by components of complement activation. The severity of changes light microscopically were more apparent in the positive immunoreactant group. Biopsies from men with androgenetic alopecia showed a similar pattern of inflammation and immunoreactant deposition. Serologic assessment for antibodies to androgen receptor, estrogen receptor or cytokeratin 15 were negative. Combined modality therapy with minocycline and topical steroids along with red light produced consistent good results in the positive immunoreactant group compared to the negative immunoreactant group.
Conclusion: A lymphocytic microfolliculitis targeting the bulge epithelium along with deposits of epithelial basement membrane zone immunoreactants are frequent findings in androgenetic alopecia and could point toward an immunologically driven trigger. Cases showing a positive immunoreactant profile respond well to combined modality therapy compared to those with a negative result.
J Drugs Dermatol. 2011;10(12):1404-1411.
Brian Berman MD PhD,a,b Charles Ellis MD,c and Craig Elmets MDd,*| |
J Drugs Dermatol. 2016;15(2):224-228.
Stacy R. Smith MD,a Xiaoming Lin MS RN,b and Ava Shamban MDc| |
J Drugs Dermatol. 2013;12(7):764-769.
Steven H. Dayan MD FACS,a,b John P. Arkins BS,c Clyde C. Mathison MDd| |
Background: As the number of soft tissue filler injections increases, the number of adverse events associated with injection may rise. Impending necrosis represents a serious complication that, if not treated correctly and timely, may have grave consequences.
Objective: We describe a protocol utilizing hyaluronidase, nitroglycerin paste, aspirin, antacid and a topical oxygen therapy that may be used to treat impending necrosis subsequent to injection with soft tissue fillers.
Conclusion: We have successfully treated nine post-filler injection adverse events involving impending necrosis or necrosis following both hyaluronic acid and calcium hydroxylapatite injections using our protocol.
J Drugs Dermatol. 2011;10(9):1007-1012.
Shannon Famenini MD and Carolyn Goh MD| |
J Drugs Dermatol. 2014;13(7):809-812.
Effect of Retinoid Pretreatment on Outcomes of Patients Treated by Photodynamic Therapy for Actinic Keratosis of the Hand and Forearm
Barry I. Galitzer MD| |
Background/Objective: Photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) has been shown to be useful in both spot and field treatments of actinic keratoses (AK). This study evaluates the safety and efficacy of pretreatment of AK lesions on the dorsal hands and forearms with tazarotene gel (0.1%) twice a day for one week before broad-area ALA PDT.
Methods: Ten subjects aged 75.4 ± 11.6 years (mean ± SD) with at least four AK lesions on their dorsal forearm or hand were randomized so that one dorsal hand or forearm was pretreated with tazarotene gel (0.1%) twice daily for one week before ALA PDT with blue light. The other hand or forearm (control) was not pretreated. After seven days, ALA was applied to both sides and incubated 60 minutes before irradiation with blue light. ALA was applied first only to the AK lesions and then to the entire treatment area (defined as the extensor surface of the hand or forearm between the elbow and the base of the fingers) before 60-minute incubation. The ALA area on the control side was occluded during the 60-minute incubation. Efficacy and adverse effects were evaluated within 48 hours and eight weeks later.
Results: For both the pretreated and control group, lesion counts of the target areas decreased significantly from baseline to eight weeks after ALA PDT. Reduction percentages of the target area, however, did not differ significantly between the two groups. When reduction percentages of the entire treatment area for both groups were compared the difference between the two groups was of borderline significance (P=0.0547). When the entire treatment area was analyzed, lesion counts of the tazarotene group differed significantly from baseline at eight weeks (P=0.0002), but this was not the case with the control group (P=0.0365). Adverse events were limited to those expected after ALA PDT. Erythema was significantly more severe (P=0.0029) in the pretreated arm five minutes after ALA PDT.
Conclusion: Pretreatment of AK lesions on the dorsal hand and forearm with tazarotene gel (0.1%) may enhance the therapeutic effect of ALA PDT without serious side effects.
J Drugs Dermatol. 2011;10(10):1124-1132.
Recent Trend in the Choice of Fillers and Injection Techniques in Asia: A Questionnaire Study Based on Expert Opinion
Soo-Keun Lee MDa and Hei Sung Kim MDb| |
OBJECTIVE: To evaluate the recent trend in the choice of fillers and injection techniques among leading dermatologists in Asia and offer guidance to those who practice facial fillers.
METHODS: A panel of dermatologists, who are recognized as filler experts and key speakers in Korea were asked to fill out an in-depth questionnaire on fillers in 2012. The results of the 2012 questionnaire are presented and compared with the questionnaire results of the exact same group of doctors in 2011.
RESULTS: Those who participated in the questionnaire study practiced fillers for an average of 10.6 years with an average of 32.8 filler cases per week. Common indications for filler injection were midface augmentation and nose augmentation. Indications that most drastically increased between 2011 and 2012 were midface and forehead augmentation. For the nasolabial folds, the most preferred choice of filler product, needle, injection technique and injection depth was Radiesse®, 27G short needle, Layering technique and the Upper subcutaneous fat layer. For filler rhinoplasty, the preferred choices were Radiesse®, 27G short needle, Linear threading technique and the Mid-deep fatty layer. For dark circles, the favored choices were Esthelis Basic®, 30G short needle, Vertical technique and the SOOF (suborbicularis oculi fat) layer. For forehead augmentation, the most favored choices were Juvederm Voluma®, 23G cannula, Linear threading technique and Fanning and the Supraperiosteal layer. The physicians’ satisfaction score for the nasolabial folds, filler rhinoplasty, dark circles and forehead augmentation was 71.5, 90, 84.5 and 87 respectively.
CONCLUSION: On general, filler experts preferred fillers with relatively high visco-elasticity for the nasolabial folds, nose augmentation and forehead augmentation but chose fillers with low visco-elasticity for dark circles. Linear treading technique (with or without fanning) was universally popular but Vertical injection was considered more useful for dark circles and the nasal tip.
J Drugs Dermatol. 2014;13(1):24-31.
Improvement in Atrophic Acne Scars Using Topical Synthetic Epidermal Growth Factor (EGF) Serum: A Pilot Study
Rachel Seidel BAa and Ronald L. Moy MD FAADb,c| |
OBJECTIVE: We evaluated the efficacy of a topically applied synthetic epidermal growth factor (EGF) serum in reducing the appearance of atrophic acne scars.
METHODS: A single-center clinical trial was performed on nine self-selected male and female patients with Goodman & Baron grade II-IV atrophic acne scars. Subjects followed a standardized treatment regimen, including twice-daily application of EGF serum to scarred areas over 12 weeks. Subject progress was evaluated at baseline and 4-week intervals by clinical photography, Investigator Global Assessment (IGA), Goodman grade and patient self-assessment. Final patient perceptions were shared by written self-assessment at the end of the study. Before and after photographs were also evaluated by a blind investigator.
RESULTS: Eight subjects completed the trial. Compared to baseline, there was an improvement in mean IGA score from 2.875 (SEM= .327) to 2.38 (SEM = .375). Mean Goodman grade was reduced from 3.00 (SEM = .309) to 2.75 (SEM = .25). Of the eight pairs of before and after photographs given to a blind investigator, five were correctly chosen as the post-treatment image. Two were assessed as “excellent” (76-100%) improvement and three were assessed as "good" (50-75%) improvement. A one-tailed paired student t-test (α = .05) using blind investigator ratings of scar severity for each before and after photograph yielded a P-value of .0019, confirming the difference as statistically significant. On final self-assessment, all but one patient reported “good” to “excellent” improvement in their scars compared to baseline. 75% of patients who received alternative treatments in prior years reported EGF serum to be more efficacious.
CONCLUSION: These results suggest that topical EGF may improve the appearance of atrophic acne scars, though further study and more objective evaluation measures are required for definitive conclusions to be drawn.
J Drugs Dermatol. 2015;14(9):1005-1010.
DNA Repair Enzymes: An Important Role in Skin Cancer Prevention and Reversal of Photodamage‑ A Review of the Literature
Yasmeen Kabir MD,a Rachel Seidel BA,b Braden Mcknight BS,c Ronald Moy MDc| |
J Drugs Dermatol. 2015;14(3):297-301.
Jordan Fabrikant DO,a Khasha Touloei DO,b and Stuart M. Brown MDc| |
J Drugs Dermatol. 2013;12(7):775-779.
Aanand N. Geria MD, Christina N. Lawson MD, Rebat M. Halder MD| |
J Drugs Dermatol. 2011;10(5):483-489.
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.
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
Cosmetic Complications: Rare and Serious Events Following Botulinum Toxin and Soft Tissue Filler Administration
Eric P. Sorensen BSa,b and Christine Urman MDb| |
OBJECTIVE: This article aims to review the rare but serious complications associated with the injectables used in cosmetic dermatology, and the pathogenesis, diagnosis, and management of each.
METHODS AND MATERIALS: A literature review for case reports pertaining to rare adverse events following botulinum toxin or soft tissue fillers was performed using the MEDLINE database.
RESULTS: Complications of BTX included dry eye syndrome, strabismus and diplopia, superficial temporal artery pseudoaneurysm, neck weakness, hoarseness, and dysphagia. Complications associated with soft tissue fillers included tissue necrosis, inflammatory nodules, hypersensitivity reaction, and blindness and cerebral ischemia.
CONCLUSION: The injector should be comfortable in diagnosing and managing the above complications, and the patient should be counseled about these potentially harmful adverse events prior to injection.
J Drugs Dermatol. 2015;14(5):486-491.
Valrubicin Activates PKCα in Keratinocytes: A Conceivable Mode of Action in Treating Hyper-Proliferative Skin Diseases
Ina Groenkjaer Laugesen MD,a Eva Hauge,a Stine Maria Andersen MD,a Karin Stenderup PhD,a
Elisabeth de Darkó MD,b Tomas Norman Dam MD PhD,c and Cecilia Rosada PhDa
OBJECTIVE: The aim of the present study was to investigate valrubicin’s mode of action in keratinocytes by studying its possible effect on PKCα activation.
METHODS: PKCα's characteristic to translocate from the cytoplasm to the cellular membrane when activated was assessed by measuring the amount of PKCα in the soluble and membrane-bound protein fractions isolated from valrubicin stimulated keratinocytes and by visualizing PKCα in stimulated cells over time. Downstream signaling was investigated by measuring the amount of phosphorylated Myristoylated Alanine-rich C-kinase substrate (MARCKS) and extracellular signal-regulated kinases (ERK) 1/2 of valrubicin-stimulated keratinocytes. To investigate whether there was a direct interaction between valrubicin and PKCα, an activity assay employing purified PKCα protein was used.
RESULTS: Valrubicin activates PKCα in vitro as shown by PKCα's translocation and phosphorylation of downstream signaling molecules.
CONCLUSION: Valrubicin stimulates PKCα activity and downstream signaling which may contribute to its beneficial effect in psoriasis and NMSC.
J Drugs Dermatol. 2013;12(10):1156-1162.
J. Mark Jackson MDa and Michelle Pelle MDb| |
Many topical medications are available for the treatment of papulopustular rosacea. While treatments contain metronidazole, azelaic acid, or sodium sulfacetamide-sulfur as the active ingredient, the composition of the vehicle formulations varies widely. These vehicles come in gels, creams, lotions and foams; some ingredients are common to many vehicles, while some vehicles contain unique ingredients designed to optimize skin penetration and delivery of the active drug to its target. Vehicles can also influence tolerability, which is always a concern in patients with heightened skin sensitivity, and compliance, which is typically lower for topical treatments than oral treatments. Ideally, the vehicle of any rosacea treatment should enhance drug delivery, be nonirritating and be easy to use. Ingredients that help repair barrier function are also desirable. This review will focus on the key components of the vehicles from the most commonly used topical therapies for papulopustular rosacea and how vehicle formulations influence the delivery of active ingredient, skin barrier repair, tolerability and compliance.
J Drugs Dermatol. 2011;10(6):627-633.
Babu Singh MD,a Terrence Keaney MD,b and Anthony M. Rossi MDc,d| |
J Drugs Dermatol. 2015;14(9):1052-1059.
Oge C. Onwudiwe MD,a Ellen S. Marmur MD,b and Joel L. Cohen MDc| |
J Drugs Dermatol. 2013;12(2):199-205.
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2016;15(1 Suppl 1):s11-s16.
Hilary E. Baldwin MD,a Neal D. Bhatia MD,b Adam Friedman MD,c Richard Martin Eng,d and Sophie Seité PhD e| |
The Effects of Topical L-Selenomethionine on Protection Against UVB-Induced Skin Cancer When Given Before, During, and After UVB Exposure
Karen E. Burke,a Xueyan Zhou,a Yongyin Wang,f Joel Commisso,b Carl L. Keenb
Robert M. Nakamura,a Gerald F. Combs Jr.,d and Huachen Weia,e
J Drugs Dermatol. 2014;13(10):1214-1223.
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