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Simpson E.,Oregon Health And Science University | Dutronc Y.,Galderma R and D
Journal of Drugs in Dermatology | Year: 2011

Moisturizers result in an increase of skin hydration and restoration of the skin barrier function and play a prominent role in the longterm management of atopic dermatitis (AD). Cetaphil RestoradermTM Moisturizer (CRM) contains novel ingredients specifically designed for AD, and its effects on skin hydration, skin barrier function and signs of AD were assessed in four studies, three of which were evaluator-blinded, randomized and intra-individual comparison trials. A single application of CRM induced significantly greater hydration than the untreated control for at least 24 hours (P<0.001). After the skin was disrupted with 0.5% sodium dodecyl sulfate (SDS), applications of CRM led to a more rapid restoration of skin barrier function and maintained significantly greater skin hydration compared to the untreated control (both P<0.05). After four weeks of twice-daily CRM application among subjects with a history of AD, a significant decrease of itching/stinging scores compared to baseline was reported, as well as an improvement in the qualityof- life and a high level of satisfaction regarding the product. When CRM was used as an adjunctive treatment with topical steroid for four weeks among subjects with mild-to-moderate AD, a more rapid decrease of overall disease severity was observed on days 7, 14 and 21 by the blinded investigator (P<0.05), compared to steroid treatment alone. In summary, CRM is suitable for the specific needs of patients with AD and can be used either alone for long-term management or in adjunction with traditional treatment for both short and long-term disease control. Copyright © 2011 Journal of Drugs in Dermatology. Source

Tan J.,University of Western Ontario | Tan J.,Windsor Clinical Research | Gollnick H.P.M.,Otto Von Guericke University of Magdeburg | Loesche C.,Galderma R and D | And 2 more authors.
Journal of Dermatological Treatment | Year: 2011

The adapalene-benzoyl peroxide (adapalene-BPO) combination gel is efficacious and safe in the treatment of acne vulgaris. We aimed in this pooled analysis to determine whether the adapalene-BPO combination demonstrates synergistic efficacy. Data were pooled and analyzed from three double-blind controlled studies, in which patients were randomized to receive adapalene-BPO, adapalene, BPO or vehicle once daily for 12 weeks. Efficacy assessments included percent reduction in lesion counts and Investigator's Global Assessment (IGA) success. Benefit of each treatment relative to vehicle was calculated by subtracting the vehicle result from the efficacy result. Synergy was defined as the benefit of the combination greater than the sum of benefits of adapalene and BPO monotherapies. Adapalene-BPO was significantly more efficacious than its monotherapies in decreasing lesion counts as early as week 1 and throughout the study (p < 0.05). Synergy in total lesion count reduction was observed up to week 8, contributing 48.7% of the benefit of adapalene-BPO relative to vehicle in decreasing total lesions at week 1. Synergy of the combination in IGA success was observed at weeks 1, 4, 8 and 12. In conclusion, the fixed-dose adapalene-BPO combination gel provides synergistic and significantly greater efficacy than its monotherapies in the treatment of acne vulgaris. © 2011 Informa Healthcare USA on behalf of Informa UK Ltd. Source

Schorr E.S.,TKL Research Inc. | Sidou F.,Galderma R and D | Kerrouche N.,Galderma R and D
Journal of Drugs in Dermatology | Year: 2012

Objectives: To assess the benefit of adjunctive use of a SPF 30 moisturizing lotion in reducing local side effects associated with atopical tretinoin cream. 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. Copyright © 2012 Journal of Drugs in Dermatology. Source

Kang H.Y.,Ajou University | Suzuki I.,Galderma R and D | Lee D.J.,Ajou University | Ha J.,I.E.C. Korea | And 6 more authors.
Journal of Investigative Dermatology | Year: 2011

Melasma is a commonly acquired hyperpigmentary disorder of the face, but its pathogenesis is poorly understood and its treatment remains challenging. We conducted a comparative histological study on lesional and perilesional normal skin to clarify the histological nature of melasma. Significantly, higher amounts of melanin and of melanogenesis-associated proteins were observed in the epidermis of lesional skin, and the mRNA level of tyrosinase-related protein 1 was higher in lesional skin, indicating regulation at the mRNA level. However, melanocyte numbers were comparable between lesional and perilesional skin. A transcriptomic study was undertaken to identify genes involved in the pathology of melasma. A total of 279 genes were found to be differentially expressed in lesional and perilesional skin. As was expected, the mRNA levels of a number of known melanogenesis-associated genes, such as tyrosinase, were found to be elevated in lesional skin. Bioinformatics analysis revealed that the most lipid metabolism-associated genes were downregulated in lesional skin, and this finding was supported by an impaired barrier function in melasma. Interestingly, a subset of Wnt signaling modulators, including Wnt inhibitory factor 1, secreted frizzled-related protein 2, and Wnt5a, were also found to be upregulated in lesional skin. Immunohistochemistry confirmed the higher expression of these factors in melasma lesions. © 2011 The Society for Investigative Dermatology. Source

Gold L.S.,Ford Motor Company | Kircik L.,Derm Research PLLC | Fowler J.,Dermatology Specialists Research | Tan J.,INC Research | And 7 more authors.
Journal of Drugs in Dermatology | Year: 2014

BACKGROUND: Treatments for papulopustular rosacea (PPR) are limited. OBJECTIVE: To demonstrate the efficacy and safety of once-daily ivermectin 1% cream in subjects with moderate to severe PPR. METHODS: Two identically designed, randomized, double-blind, controlled studies of ivermectin 1% cream (IVM 1%) or vehicle once daily for 12 weeks were conducted in subjects with moderate to severe PPR. Efficacy assessments were Investigator's Global Assessment (IGA) of disease severity and inflammatory lesion counts. Safety assessments included incidence of adverse events (AEs) and local tolerance parameters. Subjects evaluated their rosacea and completed satisfaction and quality of life (QoL) questionnaires. RESULTS: In both studies, a greater proportion of subjects in the IVM 1% group achieved treatment success (IGA "clear" or "almost clear"): 38.4% and 40.1% vs 11.6% and 18.8% for vehicle (both P CONCLUSION: Ivermectin 1% cream was effective and safe in treating inflammatory lesions of papulopustular rosacea. © 2014-Jddonline. All Rights Reserved. Source

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