Search Results for "skinmedica"
Hema Sundaram, MD| |
The gold standard for the treatment of abnormal melanin accumulation has long been 4% hydroquinone, but, given the proliferating safety concerns posed by hydroquinone, the search for novel skin brighteners has been ongoing. Several studies have demonstrated that the future for skin brighteners is now, because of the skin brightening efficacy of SkinMedica’s Lytera™, a hydroquinone-free skin-brightening complex. Lytera includes a series of formulations that utilize a multi-modal treatment approach, and it is as effective as hydroquinone over the course of 24 weeks for the treatment of facial hyperpigmentation without the concomitant toxicities of the latter.
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.
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.
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.
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.
Clinical Efficacy and Safety of a Multimodality Skin Brightener CompositionCompared With 4% Hydroquinone
Elizabeth T. Makino BS MBA,a James H. Herndon Jr. MD,b Monya L. Sigler PhD,b Vincent Gotz MS MBA,c John Garruto BS,a and Rahul C. Mehta PhDa
aSkinMedica, Inc, Carlsbad, CA bThomas J. Stephens & Associates, Inc, Carrollton, TX cProPharmaCon, LLC, Carlsbad, CA
J Drugs Dermatol. 2012;11(12):1478-1482.
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.
Assessment of a Superficial Chemical Peel Combined With a Multimodal, Hydroquinone-Free Skin Brightener Using In Vivo Reflectance Confocal Microscopy
Lisa T. Goberdhan BA, Lora Colvan BA, Elizabeth T. Makino BS CCRA MBA, Caroline Aguilar RN BSN, and Rahul C. Mehta PhD| |
J Drugs Dermatol. 2013;12(3 suppl 1):s38-s41.
Pearl E. Grimes MD| |
Six female subjects with Fitzpatrick skin types IV-V in good general health between the ages of 46 and 63 years with moderate epidermal facial melasma are presented herein. Subjects applied the skin brightener twice daily, morning and evening, and returned to the clinic at weeks 4, 8, and 12. By week 12, Investigator Overall Hyperpigmentation scores and MASI scores improved by an average of 22% and 38% from baseline, respectively. Additionally, 100% of subjects showed at least a 25% increase in Global Improvement at week 12. The skin brightener was well tolerated with no reports of erythema, edema, scaling, burning/stinging, or itching.
Results from these case studies suggest that this multimodality skin brightener may provide an alternative treatment to hydroquinone for moderate melasma in skin of color. However additional clinical studies would be needed.
J Drugs Dermatol. 2014;13(3):364-366.
Mona S. Foad MD and Erin Winters BA| |
J Drugs Dermatol. 2013;12(3 suppl 1):s42-s44.
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.
Leon H. Kircik MD| |
J Drugs Dermatol. 2013;12(11):1268-1270.
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.
Clinical Efficacy and Safety of a Multimodality Skin Brightener Composition Compared With 4% Hydroquinone
Elizabeth T. Makino BS CCRA MBA,a James H. Herndon Jr. MD,b Monya L. Sigler PhD,b Vincent Gotz MS MBA,c John Garruto BS,a and Rahul C. Mehta PhDa| |
J Drugs Dermatol. 2013;12(3 suppl 1):s21-s26.
Treatment of Mild-to-Moderate Chronic Hand Dermatitis With Clobetasol Propionate 0.05% EF Foam: Results From an Open-Label Study
Leon H. Kircik MDa,b and Cathy Tropmann RPhc| |
Objective: To assess the safety and efficacy of clobetasol propionate 0.05% emulsion formulation (EF) foam in subjects with mild-to-moderate chronic hand dermatitis.
Methods: This was a single-center, open-label pilot study of 30 adults with chronic hand dermatitis. Subjects were treated with clobetasol propionate 0.05% EF foam twice-daily and returned for assessment at day 8 and day 15. The primary efficacy endpoint was the proportion of subjects who achieved treatment success, defined as improvement of ≥1 grade in their chronic hand dermatitis as per the Investigator's Static Global Assessment (ISGA) from baseline to day 15. Safety and quality-of-life measures were also assessed.
Results: A minimum 1-grade improvement in the ISGA was achieved by 96.7 percent (29/30) of subjects at day 15, with 80 percent (24/30) of subjects achieving a score of 0 (clear) or 1 (almost clear). Clobetasol propionate 0.05% EF foam appeared to be safe and well-tolerated, with only four subjects experiencing treatment-related adverse events. No pattern of adverse event occurrence or predisposition could be delineated from this study.
Conclusion: Clobetasol propionate 0.05% EF foam appeared to be safe and effective for the treatment of chronic hand dermatitis.
J Drugs Dermatol. 2011;10(12):1398-1402.
A Randomized, Phase 2, Dose-Ranging Study in the Treatment of Moderate to Severe Inflammatory Facial Acne Vulgaris With Doxycycline Calcium
James J. Leyden MD,a Suzanne Bruce MD,b Chai Sue Lee MD,c,* Mark Ling MD PhD,d Pranav B. Sheth MD,e Daniel M. Stewart DO,f William P. Werschler MD,g Richard D. Gilbert PhD,h and Leon Kircik MDi| |
METHODS: This was a randomized, double-blind, phase 2 dose-ranging study in subjects with moderate to severe inflammatory acne aged 12 years to 45 years. Subjects were randomized to receive doxycycline calcium tablets 0.6, 1.2, or 2.4 mg/kg/day or placebo, and instructed to take their tablets once daily for 12 weeks, in the evening at least 1 hour before or 2 hours after mealtime. The primary efficacy variables were the dichotomized Investigator's Global Assessment score (success or failure) at week 12 (success defined as ≥2 score decrease from baseline) and the absolute change from baseline to week 12 in inflammatory lesion count.
RESULTS: A dose-response effect was seen with doxycycline calcium formulation in subjects with moderate to severe inflammatory acne. The highest dose-group (corresponding to approximately 2.4 mg/kg/day) showed a statistically significant difference from placebo. The dose-response effect was confirmed by logistic regression analysis for both treatment success and incidence of gastrointestinal adverse events. A limitation of this study is that safety and efficacy were only studied on moderate to severe inflammatory acne. Also, the study was not prospectively powered to show efficacy differences.
CONCLUSION: Doxycycline calcium shows a dose-response effect in reducing inflammatory lesions in subjects with moderate to severe inflammatory acne.
J Drugs Dermatol. 2013;12(6):658-663.
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.
Comparative Study of the Efficacy and Tolerability of a Unique Topical Scar Product vs White Petrolatum Following Shave Biopsies
Leon H. Kircik MD| |
The principles underlying scar formation are now better understood. Products are being developed to address those critical components of the wound-healing process, namely inflammation, hydration, and collagen maturation. A multicomponent scar product was previously shown effective in preventing exaggerated scarring in patients undergoing various surgical procedures. The present outpatient study was conducted in patients undergoing shave biopsies. Following reepithelialization, this investigator-blinded, randomized, 8-week trial compared twice-daily application of either the scar product or the standard of care, white petrolatum. Evaluation visits were conducted at baseline and at weeks, 1, 2, 4 and 8. Subjects were evaluated by the blinded investigator for clinical efficacy and tolerability using grading scales. Standardized digital photographs were taken at each visit, and subjects completed a self-assessment questionnaire regarding treatment effectiveness and satisfaction. Twenty-eight subjects completed the 8-week study. The scar product provided earlier improvements than the white petrolatum. At week 1, 70% of subjects receiving the scar product demonstrated at least 50% global improvement in scar appearance vs only 42% of the subjects receiving white petrolatum. The more rapid improvement was accompanied by greater reductions in stinging/burning and itching with the scar product at all visits. Importantly, there was also greater subject satisfaction with the scar product at all visits. This scar product may be useful in hastening the healing of cutaneous shave biopsies and reducing the stinging/burning and itching associated with the normal healing process.
J Drugs Dermatol. 2013;12(1):86-90.
The Efficacy and Safety of Topical Dapsone Gel, 5% for the Treatment of Acne Vulgaris in Adult Females With Skin of Color
Andrew F. Alexis MD MPH,a Cheryl Burgess MD,b Valerie D. Callender MD,c Jo L. Herzog MD,d Wendy E. Roberts MD,e Eric S. Schweiger MD,f Toni C. Stockton MD,g and Conor J. Gallagher PhDh| |
OBJECTIVE: Evaluate safety and efficacy of dapsone gel, 5% applied topically twice daily for 12 weeks in women with SOC.
METHODS: Females with SOC aged 18 years and older with facial acne participated in a multicenter, open-label, single-group, 12-week pilot study of twice-daily monotherapy with dapsone gel, 5%. The investigator-rated 5-point Global Acne Assessment Score (GAAS) was used to assess efficacy. The impact of acne on subjects was assessed using the validated Acne Symptom and Impact Scale (ASIS).
RESULTS: The study enrolled and treated 68 women with SOC and facial acne. GAAS decreased significantly from baseline to week 12 (mean, -1.2 [95% CI, -1.4, -1.0]; P<.001), a 39.0% improvement. Overall, 42.9% of subjects were responders based on a GAAS of 0 or 1 at week 12. Subjects also experienced significant reductions in mean total lesions (52% decrease), inflammatory lesions (65%), and comedo counts (41%; all P<.001). Dapsone gel, 5% monotherapy was associated with significant improvement in subject-assessed acne signs (P<.001) and impact on quality of life (QOL; P<.001), based on ASIS. Dapsone gel, 5% used twice daily was well tolerated, with no treatment-related adverse events. The local dermal tolerability scores tended to remain stable or decrease from baseline to week 12.
CONCLUSIONS: Monotherapy with dapsone gel, 5% administered twice daily was safe and effective for treatment of facial acne in women with SOC. Significant improvement in overall acne severity and both inflammatory lesions and comedones was observed. Further, study subjects reported considerable improvement in both acne signs and impact on QOL.
J Drugs Dermatol. 2016;15(2):197-204.
Suzanne Bruce MD| |
OBJECTIVE: The skin brightening complex was studied for efficacy and tolerability in subjects with moderate to severe facial hyperpigmentation.
METHODS: Subjects were instructed to apply skin brightening complex to the entire face twice daily and to follow a standard skin care regimen (facial cleanser, moisturizer, and sunscreen) during the course of the study. The study was conducted over a 12-week period and consisted of evaluation visits at baseline and at weeks 4, 8, and 12. At each visit, subjects were evaluated by an investigator for clinical efficacy and tolerability using grading scales. Standardized digital photographs and spectrophotometric assessments were also taken. Self-assessment questionnaires were completed at weeks 4, 8, and 12. To assess longer-term safety and efficacy, 10 subjects elected to continue treatment for an additional 12 weeks (24 weeks total), with evaluations at weeks 18 and 24.
RESULTS: Twenty-six subjects completed the 12-week study, and 8 subjects completed treatment for an additional 12 weeks (24 weeks in total). In the 12-week study, the skin brightening complex was shown to be effective and significantly improved Overall Hyperpigmentation at weeks 4, 8, and 12 compared with baseline. The skin brightening complex also significantly improved the Mottled Pigmentation Area and Severity Index ([MoPASI], a modified Melasma Area and Severity Index [MASI] scale) at weeks 8 and 12 compared with baseline. These efficacy benefits continued at 24 weeks. The product was well tolerated at all evaluation visits. Subject questionnaires showed 80% or more of the subjects reporting pigmentation improvement and satisfaction with the skin brightening complex at all evaluation visits.
CONCLUSION: This HQ-free skin brightening complex was effective and well tolerated in subjects with facial hyperpigmentation who were treated for as long as 24 weeks.
J Drugs Dermatol. 2013;12(3 suppl 1):s27-s31.
Alan R. Shalita MD, Guy F. Webster MD PhD, Mitchell S. Wortzman PhD, Diane Nelson BSN MPH| |
Leon H. Kircik MD| |
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.
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.
Topical Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Maintains Efficacy of Etanercept After Step-Down Dose in Patients With Moderate-to-Severe Plaque Psoriasis: Results of an Open Label Trial
Trial Design: In this single-center, open-label study, subjects (n=20) underwent 12 weeks treatment with etanercept 100 mg/week (50 mg, 2x week; weeks –12 to -1), followed by etanercept 50 mg/week maintenance therapy for 40 weeks (weeks 0 to 40). Subjects were followed at four-week intervals. Starting at week 4, subjects who demonstrated an increase from baseline (week 0) body surface area (BSA) of >2% initiated therapy with calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment for four weeks. The study is limited by its small sample size, open-label nature, and lack of blinding.
Findings: Mean BSA involvement decreased significantly from week –12 to 0 with etanercept 50 mg twice a week. At week 4, on the etanercept 50 mg/week dose, mean BSA increased to 9.42±9.39 compared to week 0. With introduction of calcipotriene 0.005%/betamethasone dipropionate 0.064% ointment at week 4, mean BSA decreased to 4.62±8.19 by week 24 and was relatively stable for the remainder of the study period. Similarly, mean PASI (Psoriasis Area and Severity Index) scores improved from week -12 to week 0, increased at week 4, then decreased significantly by week 24 with adjunctive topical treatment.
Conclusion: Topical calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment is a safe and effective adjunct to etanercept 50 mg/week maintenance therapy.
J Drugs Dermatol. 2011;10(8):881-885.
A Randomized, Investigator-Blinded Comparison of Two Topical Regimens in Fitzpatrick Skin Types III-VI With Moderate to Severe Facial Hyperpigmentation
Monique J. Vanaman Wilson MD,a Isabela T. Jones MD,b Joanna Bolton MD,c Lisa Larsen DO,d Douglas C. Wu MD PhD,e and Mitchel P. Goldman MDe,f| |
Purpose: Though hydroquinone (HQ) remains the gold standard for treatment of hyperpigmentation, concerns about its safety have prompted the development of HQ-free topical skin lightening systems. Objective: To compare the efficacy and tolerability of a new HQ-free system and a popular HQ-based system for the improvement of facial hyperpigmentation and photoaging in darker skin types. Methods: This investigator-blinded trial randomized 30 subjects of Fitzpatrick skin types III to VI with moderate to severe hyperpigmentation to a new 7-product HQ-free system or a 7-product HQ-based system for 12 weeks. At 4, 8, and 12 week follow-up visits, a blinded investigator assessed efficacy and tolerability using standardized scales. Subjects also performed a self-assessment at each visit. Summary: Both the HQ-free and HQ-based systems produced significant improvements in Overall Hyperpigmentation that were sustained through week 12 (P=0.008, 0.0003). The HQ-based system demonstrated better improvement in overall hyperpigmentation at weeks 4, 8, 12 (P=0.01, 0.001, 0.003, respectively). Mottled Pigmentation Area Severity Index (MoPASI) scores improved with both systems (P=0.02, 0.01), with no statistically significant differences between the two treatment groups. Subject-rated hyperpigmentation was not different between groups. Subjects reported significantly more discomfort with the HQ-free system at week 8 (P=0.02); otherwise, measures of irritation were the same between groups. All irritation was described as mild to moderate. At week 12, 100% of subjects in the HQ-free group and 92.3% of subjects in the HQ-based group were satisfied with their outcome. Conclusion: Both a new HQ-free skincare system and a widely-available HQ-based system improved hyperpigmentation in Fitzpatrick skin types III to VI. Though the HQ-based system produced greater improvement in hyperpigmentation when compared to the HQ-free system, there was no difference in MoPASI scores between the treatment groups. Subjects were satisfied with both treatments and reported only mild to moderate irritation using either system.
J Drugs Dermatol. 2017;16(11):1127-1132.
Randomized, Controlled, Evaluator-Blinded Studies Conducted to Compare the Efficacy and Tolerability of 3 Over-the-Counter Acne Regimens in Subjects With Mild or Moderate Acne
Lawrence Green MD,a Leon H. Kircik MD,b-d and Jennifer Gwazdauskas MBAe| |
Objectives: To compare the efficacy, user satisfaction, and tolerability of the OTC regimens MaxClarity™, Proactiv®, and Murad® in the treatment of mild and moderate acne. Methods: Two randomized, evaluator-blinded, split-face studies were conducted, each involving 20 subjects with acne, to evaluate MaxClarity against Proactiv (study 401) and MaxClarity against Murad (study 404) over 8 weeks.
Results: Clinically and statistically significant reductions in acne lesion counts were achieved at 8 weeks compared with baseline for each regimen using MaxClarity, Proactiv, and Murad. Similar reductions in lesion counts and improvements in Investigator's Static Global Assessment grades were observed between MaxClarity and either Proactiv or Murad, in the respective studies. MaxClarity was well tolerated, with no treatment-related adverse events observed in any treatment group and no discontinuations due to adverse events. Overall, most subjects were satisfied with all study treatments.
Conclusions: MaxClarity is an effective alternative to either Proactiv or Murad for use in the treatment of mild and moderate acne.
J Drugs Dermatol. 2013;12(2):180-185.
Combination of In-Office Chemical Peels With a Topical Comprehensive Pigmentation Control Product in Skin of Color Subjects With Facial Hyperpigmentation
Jeanine Downie MD, a Katie Schneider BS, b Lisa Goberdhan BA, b Elizabeth T. Makino BS CCRA MBA, b and Rahul C. Mehta PhD b| |
Dyschromia is one of the primary complaints for patients with skin of color. Treatments need to achieve a balance between tolerability and efficacy to address existing hyperpigmentation without causing additional damage that could trigger post-inflammatory hyperpigmentation (PIH). An open-label, single-center study was conducted to assess the efficacy of a novel comprehensive pigmentation control serum (LYT2) combined with a series of three very superficial chemical peels (VP) in skin of color subjects. Seventeen female and male subjects aged 36 to 69 years with Fitzpatrick Skin Types III-VI and moderate to severe facial hyperpigmentation were enrolled in the 12-week clinical study. Subjects identified as Asian, Hispanic, African American, or Caucasian ethnicities. Subjects received a series of 3 VP treatments every 4 weeks. LYT2 was applied twice-daily in between VP treatments. Investigator assessments for overall hyperpigmentation, overall photodamage, and skin tone unevenness, as well as standardized digital photography and subject self-assessment questionnaires were conducted at all visits (baseline and weeks 4, 8, and 12). In vivo reflectance confocal microscopy (RCM) of a target lesion was conducted (in a subset of subjects) at baseline and week 12. Fourteen subjects completed the study. The treatment regimen provided statistically significant improvements in all efficacy parameters at weeks 8 and 12 (all P less than equal to 0.03, student’s t-test). Standardized digital photography and RCM images support the improvements in overall hyperpigmentation observed by the investigator. At the end of treatment, the regimen was highly rated by subjects with 100% of subjects (strongly agree/agree) that the combination “decreased the appearance of uneven skin tone and discolorations” and “reduced the appearance of sun damage.” In addition to this clinical study, independent case studies with this combination treatment regimen at a separate study site were also conducted with results that corroborate the formal clinical study findings. The comprehensive results from these studies suggest that the combination of a comprehensive pigmentation control serum with a series of 3 very superficial chemical peels may provide an effective treatment approach for hyperpigmentation in skin of color patients.
J Drugs Dermatol. 2017;16(4):301-306.
Andrew F. Alexis MD MPHa and Paul Blackcloud BA| |
J Drugs Dermatol. 2013;12(suppl 9):s123-s127.
Use of Naftifine Hydrochloride 2% Cream and 39% Urea Cream in the Treatment of Tinea Pedis Complicated by Hyperkeratosis
Leon Kircik MDa,b,c and Neh Onumah MDd| |
J Drugs Dermatol. 2014;13(2):162-165.
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.
Evaluation of the Efficacy, Tolerability, and Safety of an Over-the-Counter Acne Regimen Containing Benzoyl Peroxide and Salicylic Acid in Subjects With Acne
Leon H. Kircik MD,a-c Lawrence J. Green MD,d Joseph Eastern MD,e Victoria Butners BSc,f and Jennifer Gwazdauskas MBAf| |
J Drugs Dermatol. 2013;12(3):259-264.
Leon H. Kircik MD| |
J Drugs Dermatol. 2014;13(4):466-470.
Efficacy and Safety of Ingenol Mebutate 0.015% Gel After Cryosurgery of Actinic Keratosis: 12-Month Results
Brian Berman MD PhD,a Gary Goldenberg MD,b C. William Hanke MD,c Stephen K. Tyring MD PhD,d
Wm Philip Werschler MD,e Kim Mark Knudsen PhD,f Thomas Larsson Dr Med Sci,g and Neil Swanson MDh
METHODS: In this phase 3, randomized, double-blind, vehicle-controlled study (NCT01541553), patients ≥18 years with four to eight clinically typical, visible, discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015% or vehicle gel for 3 consecutive days. Endpoints included complete clearance at week 11 and safety and efficacy over 12 months.
RESULTS: In 329 randomized patients, complete clearance rates were greater with ingenol mebutate than vehicle (week 11: 60.5% vs 49.4%; P=.04; month 12: 30.5% vs 18.5%; P=.01). Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle (38.9% vs 51.9%; P=.02). At month 12, mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle (68.2% vs 54.1%; P=.002). The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel: 78% vs 68% at 6 months; 64% vs 57% at 9 months; 55% vs 40% at month 12, respectively. Ingenol mebutate 0.015% gel was well tolerated and no unexpected adverse events occurred; all adverse events resolved within 2 weeks of starting treatment.
CONCLUSIONS: Field treatment with ingenol mebutate 0.015% gel following cryosurgery significantly enhanced clearance of baseline lesions, and was well tolerated. Furthermore, ingenol mebutate 0.015% gel following cryosurgery reduced development of new lesions in the treated field.
J Drugs Dermatol. 2014;13(6):741-747.
Efficacy and Safety of Ingenol Mebutate 0.015% Gel 3 Weeks After Cryosurgery of Actinic Keratosis: 11-Week Results
Brian Berman MD PhD,a Gary Goldenberg MD,b C. William Hanke MD,c Stephen K. Tyring MD PhD,d Wm Philip Werschler MD,e Kim Mark Knudsen PhD,f Joana Goncalves MD,g Thomas Larsson Dr Med Sci,h Torsten Skov MD PhD,i and Neil Swanson MDj| |
METHODS: FIELD Study 1 (NCT01541553) is a phase 3, multicenter, randomized, double-blind study that evaluated the short- (11-week) and long- (12-month) term efficacy and safety of sequential AK treatment using cryosurgery with liquid nitrogen followed by ingenol mebutate gel, versus cryosurgery followed by vehicle.
RESULTS: Overall, 329 patients were randomized to ingenol mebutate 0.015% gel (n=167) or vehicle (n=162) 3 weeks after cryosurgery. Baseline characteristics were balanced across groups. At week 11, complete clearance rate (100%) in the treatment area was higher for ingenol mebutate gel compared with vehicle (60.5% vs 49.4%, respectively; P=.04). Mean percentage reduction in number of AKs versus baseline was also numerically higher for ingenol mebutate gel (82.7% vs 75.6%). A general reduction from baseline lesion count was observed 3 weeks after cryosurgery. Treatment after cryosurgery was well tolerated.
CONCLUSIONS: Short-term (11-week) AK clearance rates on the face or scalp with ingenol mebutate gel after cryosurgery were higher than with cryosurgery alone.
J Drugs Dermatol. 2014;13(2):154-160.
Upregulation of Extracellular Matrix Genes Corroborates Clinical Efcacy of Human Fibroblast-Derived Growth Factors in Skin Rejuvenation
Kuniko Kadoya PhD,a Elizabeth T. Makino BS CCRA MBA,a Lily I. Jiang PhD,b Michael Bachelor PhD,c Robin Chung BS,a Priscilla Tan BA,a Tsing Cheng PhD,a Gail K. Naughton PhD,d and Rahul C. Mehta PhDa| |
Skin care products may use various active ingredients to support skin rejuvenation including growth factors and other molecules that help to regenerate extracellular matrix (ECM) and promote skin repair. The biological effect of skin care products with a strong anti-aging claim was assessed in gene expression analyses using an in vitro human skin model. Application of products containing human fbroblast-derived growth factors resulted in signifcant upregulation of genes encoding ECM components including collagens and elas-tin. Human fbroblasts cultured under hypoxic conditions show increased gene expression of stem cell markers, and their conditioned media could possibly further support skin rejuvenation. Furthermore, a double-blind, randomized, placebo-controlled study was con-ducted in subjects with moderate to severe facial photodamage to assess the cosmetic clinical effcacy of a product containing human fbroblast-derived growth factors. The test product group demonstrated signifcantly greater reductions in the appearance of fne lines/wrinkles, coarse line/wrinkles, and overall photodamage, compared to the placebo group. Altogether, the results suggest that human fbroblast-derived growth factors support skin rejuvenation by stimulating dermal fbroblasts to generate ECM.
J Drugs Dermatol. 2017;16(12):1190-1196.
Ethan T. Routt MD,a Shelbi C. Jim On MD,a Joshua A. Zeichner MD,a and Leon H. Kircik MDb,c,d| |
J Drugs Dermatol. 2014;13(4):391-395.
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.
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.
Andrew F. Alexis MD MPH| |
J Drugs Dermatol. 2014;13(suppl 6):s61-s65.
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| |
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.
Clinical Evidence for the Role of a Topical Anti-Inflammatory Agent in Comedonal Acne: Findings From a Randomized Study of Dapsone Gel 5% in Combination With Tazarotene Cream 0.1% in Patients With Acne Vulgaris
Emil Tanghetti MD,a Sunil Dhawan MD,b Lawrence Green MD,c Mark Ling MD PhD,d Jeanine Downie MD,e Marguerite A. Germain MD,f J. Scott Kasteler MD,g Leon Kircik MD,h Michael G. Oefelein MD,i Zoe Draelos MDj| |
Background: Acne pathogenesis is multifactorial and includes inflammation. Combining drugs targeting multiple components of
acne pathogenesis is standard practice.
Objective: To assess the safety and efficacy of dapsone gel 5%, an anti-inflammatory agent, in combination with tazarotene cream 0.1% for treatment of acne vulgaris.
Methods: Patients were randomized to receive combination therapy (dapsone gel 5% twice-daily plus tazarotene cream 0.1% daily) or monotherapy (tazarotene cream 0.1% daily). Efficacy and safety data were collected after 1, 2, 4, 8, and 12 weeks of treatment.
Results: Patients in both arms (n=86, dapsone + tazarotene; n=85, tazarotene) showed significant reductions from baseline in inflammatory, noninflammatory and total lesion counts (P<.001 for all). At 12 weeks, patients treated with dapsone plus tazarotene showed a greater reduction from baseline in noninflammatory (comedonal) and total lesion counts than tazarotene-treated patients (noninflammatory, 59.7 percent vs. 46.5 percent, P=.01; total, 63.3% vs. 53.6%, P=.02). The percentage of patients achieving treatment success (an investigator subjective score of 0 [none] or 1 [minimal]) was greater in dapsone plus tazarotene-treated patients (42.2%) than in tazarotene-treated patients (21.8%;P=.01). Both treatments were well tolerated.
Conclusion: Combination therapy with dapsone gel 5% plus tazarotene cream 0.1% was more effective than tazarotene monotherapy for treatment of comedonal acne. The results suggest that anti-inflammatory agents such as dapsone can effectively treat early stages of acne (both comedonal and noncomedonal) when used in combination with a retinoid.
J Drugs Dermatol. 2011;10(7):783-792.
Why Is Rosacea Considered to Be an Inflammatory Disorder?
The Primary Role, Clinical Relevance, and Therapeutic Correlations of Abnormal Innate Immune Response in Rosacea-Prone Skin
The pathophysiology of rosacea has undergone renewed interest over the past decade, with a large body of evidence supporting the role of an abnormal innate immune response in rosacea. Many mechanisms interact with the cutaneous innate immune system that may be operative. A variety of potential triggers stimulate this immune detection system which is upregulated and hyper-responsive in facial skin of patients with rosacea as compared to normal skin. Based on the most current data, two conclusions have been reached. First, the major presentations of rosacea appear to be inflammatory dermatoses. Second, the presence of a microbial organism is not a primary or mandatory component of the pathogenesis of rosacea. Available therapies for rosacea exhibit reported modes of action that appear to correlate with the inhibition of inflammatory processes involved in the pathophysiology of at least some presentations of rosacea.
J Drugs Dermatol.2012;11(6):694-700.
Wm. Philip Werschler MD FAAD FAACS,a Julius W. Few Jr. MD,b Carolyn I. Jacob MD FAAD,c
John H. Joseph MD,d James M. Spencer MD MS,e and Amy Forman Taub MDf
J Drugs Dermatol. 2016;15(5):518-525.
Wendy E. Roberts MD| |
J Drugs Dermatol. 2014;13(4):472-482.
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