Galderma RandD

Sophia, France

Galderma RandD

Sophia, France
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Sanchez N.P.,Sanchez Dermatology | Bucko A.,Academic Dermatology Associates | Fowler J.,Dermatology Specialists | Jarratt M.,DermResearch Inc. | And 4 more authors.
British Journal of Dermatology | Year: 2011

Background Acne vulgaris is a chronic and frequently recurring disease. A fixed-dose adapalene-benzoyl peroxide (adapalene-BPO) gel is an efficacious and safe acne treatment. Objectives To assess the long-term effect of adapalene-BPO on relapse prevention among patients with severe acne after successful initial treatments. Methods This is a multicentre, double-blind, randomized and controlled study. In total, 243 subjects who had severe acne vulgaris and at least 50% global improvement after a previous 12-week treatment were randomized into the present study to receive adapalene-BPO gel or its vehicle once daily for 24 weeks. Results At week 24, compared with vehicle, adapalene-BPO resulted in significantly higher lesion maintenance success rate (defined as having at least 50% improvement in lesion counts achieved in initial treatment) for all types of lesions (total lesions: 78·9% vs. 45·8%; inflammatory lesions: 78·0% vs. 48·3%; noninflammatory lesions: 78·0% vs. 43·3%; all P < 0·001). Significantly more subjects with adapalene-BPO than with vehicle had the same or better Investigator's Global Assessment score at week 24 than at baseline (70·7% vs. 34·2%; P < 0·001). The time when 25% of subjects relapsed was 175 days with adapalene-BPO and 56 days with vehicle (17 weeks earlier; P < 0·0001). Adapalene-BPO led to further decrease of lesion counts during the study and 45·7% of subjects were 'clear' or 'almost clear' at week 24. It was also safe and well tolerated in the study. Conclusions Adapalene-BPO not only prevents the occurrence of relapse among patients with severe acne, but also continues to reduce disease symptoms during 6 months. © 2011 The Authors. BJD © 2011 British Association of Dermatologists.

Rzany B.,Charité - Medical University of Berlin | Cartier H.,Center Medical Saint Jean | Kestemont P.,Nice University Hospital Center | Sattler G.,Rosenparkklinik GmbH | And 3 more authors.
Dermatologic Surgery | Year: 2012

Background Full-face rejuvenation with dermal fillers in patients with multiple aesthetic indications is rarely studied. Objective To assess whether a new range of hyaluronic acid filler is suitable for full-face rejuvenation and to evaluate efficacy, safety, and patient satisfaction. Materials and Methods In this 6-month study, participants could receive five different fillers from the same range (HA E)for up to eight indications (periorbital lines, tear troughs, cheeks, cheek folds, nasolabial folds, upper lip lines, lips, and marionette lines). Outcomes included global aesthetic improvement, improvement in each indication, adverse events, local tolerability, and satisfaction. Results Seventy-seven participants with a mean age of 54.5 were enrolled; 48.1% had five or more indications treated. Mean total injection volume (baseline and touch-up) per participant was 6.7 mL. At month 6, 92.1% of participants remained at least improved over baseline, 79.7% of participants were satisfied or very satisfied with the durability of the results, and 63.0% of participants felt a lot or much better than before injection. No specific safety concerns were reported except expected injection site reactions. Conclusion In participants with multiple indications, full-face rejuvenation using HA E provided effective, safe, satisfactory results. © 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

Molina B.,Medikas | Grangier Y.,Clinique de lOcean | Ribe N.,Institute Dra Natalia Ribe | Prager W.,Dermatologikum | And 2 more authors.
Journal of the European Academy of Dermatology and Venereology | Year: 2015

Background Whilst the efficacy and safety of glabella complex treatment with botulinum toxin type A (Speywood Unit) [BoNT-A (s.U)] has been comprehensively studied, there are very few trials on patient-reported outcomes and patient satisfaction associated with this treatment. Objective To assess the level of patient satisfaction 3 weeks and 4 months after the treatment of glabellar lines with BoNT-A (s.U). Methods This is a multi-centre, prospective, non-interventional observational study carried out in France, Germany, Spain and the United Kingdom. Subjects were eligible if the investigator had already decided to prescribe BoNT-A (s.U), according to the labelling. Subjects completed a questionnaire at both 3 weeks and 4 months after treatment. Results About 533 subjects completed at least one of the two questionnaires. About half of the subjects (47.9%) were naive to BoNT-A treatment of the glabella, while 50.6% had previously received another product. A high level of satisfaction was observed after the treatment, with 94.7% and 89.6% of subjects being satisfied or very satisfied with the aesthetic outcome at week 3 and month 4, respectively. Treatment was safe and well tolerated, as directly determined in the survey. Major reasons for satisfaction included the positive aesthetic outcome, a natural appearance, a rested look and comfort of injection. Most subjects felt the treatment brought them 'harmony', 'self-esteem/confidence' or 'youth'. Of the subjects who had previously been treated with another product, 51.2% considered the results obtained in the present study with BoNT-A (s.U) were better. Conclusion Treatment of the glabellar lines with BoNT-A (s.U) led to a high level of patient satisfaction and a more positive self-perception up to 4 months after the treatment, regardless of whether the patients were naive or not to BoNT-A treatment. © 2014 Galderma. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons, Ltd. on behalf of European Academy of Dermatology and Venereology.

Fowler J.,University of Louisville | Jarratt M.,DermResearch Inc. | Moore A.,Arlington Center for Dermatology | Meadows K.,Education and Research Foundation Inc. | And 4 more authors.
British Journal of Dermatology | Year: 2012

Background Erythema of rosacea is thought to result from abnormal cutaneous vasomotor activity. Brimonidine tartrate (BT) is a highly selective α 2-adrenergic receptor agonist with vasoconstrictive activity. Objective To determine the optimal concentration and dose regimen of topical BT gel for the treatment of erythema of rosacea and to evaluate its efficacy and safety. Methods In study A, 122 subjects were randomized to receive a single application of BT 0·07%, 0·18%, 0·5% or vehicle. In study B (4-week treatment and 4-week follow-up), 269 subjects were randomized to receive BT 0·5% once daily, BT 0·18% once daily, vehicle once daily, BT 0·18% twice daily or vehicle twice daily. Evaluations included Clinician's Erythema Assessment (CEA), Patient's Self-Assessment (PSA), Chroma Meter measurements and adverse events. Results In study A, a single application of topical BT gel reduced facial erythema in a dose-dependent fashion. A significant difference between BT 0·5% and vehicle in Chroma Meter redness value was observed from 30 min to 12 h after application. In study B, BT 0·5% once daily had a statistically superior success profile (defined as a two-grade improvement on both CEA and PSA over 12 h) compared with vehicle once daily on days 1, 15 and 29 (all P < 0·001). No tachyphylaxis, rebound of erythema or aggravation of other disease signs (telangiectasia, inflammatory lesions) was observed. All regimens were safe and well tolerated with similarly low incidence of adverse events. Conclusions Once-daily BT gel 0·5% is well tolerated and provides significantly greater efficacy than vehicle gel for the treatment of moderate to severe erythema of rosacea. © 2011 The Authors. BJD © 2011 British Association of Dermatologists.

Simpson E.,Oregon Health And Science University | Bohling A.,Proderm | Bielfeldt S.,Proderm | Bosc C.,Galderma RandD | Kerrouche N.,Galderma RandD
Journal of Dermatological Treatment | Year: 2013

Background: Atopic dermatitis (AD) is characterized by barrier abnormalities, including insufficient ceramides in the stratum corneum (SC). Objective: To measure the effects of a new moisturizer (CRM) containing a ceramide precursor in improving skin barrier function in patients with controlled atopic dermatitis. Methods: In this randomized, intra-individual comparison, investigator-blinded study, CRM was applied to the test area of one lower leg for 27 days (the other leg remained as untreated control). Evaluations at baseline and day 28 included transepidermal water loss (TEWL), skin hydration by corneometry, dryness severity, Raman spectroscopy, and collection of adverse events. Results: After 4 weeks of treatment, results showed a significantly greater reduction of TEWL and clinical dryness scores, and increased skin hydration (all p < 01) in the CRM-treated than untreated area. A significantly higher level of ceramide (p < 05) and a trend toward increased water content was observed with Raman in the SC for CRM than for the control. There were no related AEs. Conclusion: Skin barrier function and hydration were significantly improved after CRM treatment. © 2013 Informa Healthcare USA on behalf of Informa UK Ltd.

Ortonne J.-P.,Hopital de lArchet 2 | Nikkels A.F.,CHU du Sart Tilman | Reich K.,SCIDerm GmbH | Ponce Olivera R.M.,Hospital General Of Mexico | And 4 more authors.
British Journal of Dermatology | Year: 2011

Background Topical antifungals and corticosteroids are the mainstay of treatment for seborrhoeic dermatitis. The short-contact clobetasol propionate 0·05% shampoo (CP) is an efficacious and safe once-daily treatment for scalp psoriasis. Objectives To evaluate the efficacy and safety of CP alone and combined with ketoconazole shampoo 2% (KC) in the treatment of moderate to severe scalp seborrhoeic dermatitis. Methods This randomized and investigator-blinded study consisted of three phases, each lasting 4 weeks. During the treatment phase, subjects were randomized to receive KC twice weekly (K2), CP twice weekly (C2), CP twice weekly alternating with KC twice weekly (C2 + K2) or CP four times weekly alternating with KC twice weekly (C4 + K2). All subjects received KC once weekly during the maintenance phase and were untreated during the follow-up phase. Results At the end of the treatment phase, all three CP-containing regimens were significantly more efficacious than K2 in decreasing the overall disease severity (P < 0·05). Both combination regimens were also significantly more efficacious than K2 in decreasing each individual sign of the disease (P < 0·05). While the C2 and C4 + K2 groups experienced slight worsening during the maintenance phase, the efficacy of C2 + K2 was sustained and remained the highest among all groups. All regimens were well tolerated without inducing any skin atrophy. Similarly low incidences of telangiectasia, burning and adverse events were observed among the four groups. Conclusions The combination therapy of twice-weekly CP alternating with twice-weekly KC provided significantly greater efficacy than KC alone and a sustained effect in the treatment of moderate to severe scalp seborrhoeic dermatitis. © 2011 The Authors. BJD © 2011 British Association of Dermatologists 2011.

Taieb A.,Service de Dermatologie et Dermatologie Pediatrique | Ortonne J.P.,Service de Dermatologie | Ruzicka T.,Ludwig Maximilians University of Munich | Roszkiewicz J.,Medical University of Gdańsk | And 3 more authors.
British Journal of Dermatology | Year: 2015

Background Few therapeutic alternatives currently exist in the treatment of papulopustular rosacea (PPR). Objectives To demonstrate superiority of once-daily ivermectin 1% cream (IVM 1%) once daily vs. twice-daily metronidazole (MTZ 0·75%) cream, regarding percentage reduction of inflammatory lesions in subjects with moderate to severe PPR. Methods In this Phase 3, investigator-blinded, randomized, parallel-group study, subjects received IVM 1% once daily, or MTZ 0·75% twice daily over 16 weeks. Efficacy assessments were inflammatory lesion counts and Investigator's Global Assessment (IGA). Safety assessments included incidence of adverse events (AEs) and local tolerance parameters. Subjects evaluated their disease following a 5-grade scale and completed questionnaires. Results A total of 962 subjects were randomized to receive IVM 1% (n = 478) or MTZ 0·75% (n = 484). At week 16, IVM 1% was significantly superior to MTZ 0·75% in terms of reduction from baseline in inflammatory lesions (83·0% vs. 73·7%; P < 0.001), observed as early as week 3 (Last Observation Carried Forward, LOCF). IGA results (subjects 'clear' or 'almost clear') also favoured IVM 1%: 84·9% vs. 75·4%, respectively (P < 0.001). Incidence of AEs was comparable between groups and local tolerability was better for IVM 1%. More subjects receiving IVM rated their global improvement as 'excellent' or 'good.' Conclusions Ivermectin 1% cream was significantly superior to MTZ 0·75% cream and achieved high patient satisfaction. What's already known about this topic? Few therapeutic alternatives currently exist in treating papulopustular rosacea (PPR). What does this study add? Ivermectin 1% cream (IVM 1%) once daily was significantly superior to metronidazole 0·75% cream (MTZ 0.75%) twice-daily, in reducing inflammatory lesion counts, as early as week 3 and through 4 months of treatment. IVM 1% cream can be considered an effective anti-inflammatory treatment for PPR. © 2014 British Association of Dermatologists.

Fowler J.,University of Louisville | Tan J.,University of Western Ontario | Jackson J.M.,University of Louisville | Meadows K.,Education and Research Foundation Inc | And 3 more authors.
Journal of the European Academy of Dermatology and Venereology | Year: 2015

Background Once-daily brimonidine tartrate (BT) 0.5% gel was shown to provide significantly greater efficacy vs. vehicle for the treatment of facial erythema in patients with rosacea. Objectives To demonstrate that patient satisfaction with overall appearance is correlated with reduction in facial erythema, as measured by clinician and patient assessments. Methods Data from two identical phase III, multicentre, randomized, controlled trials of moderate facial erythema of rosacea (study A: n = 260; study B: n = 293) with topical BT 0.5% compared to vehicle gel once-daily for 4 weeks were analysed. Correlations of Patient's Assessment of Appearance (PAA) with Clinician's Erythema Assessment (CEA) and Patient's Self-Assessment (PSA) of erythema were evaluated by calculation of gamma statistics. Results PAA correlated with CEA post-application on Days 1, 15 and 29 for the intent-to-treat population and provided a median gamma value of 0.57 (min = 0.28, max = 0.61). PAA and PSA was also highly correlated post-application on Days 1, 15 and 29; with a median gamma value of 0.87 (min = 0.66, max = 0.89). Subjects who achieved a clinically meaningful improvement in both CEA and PSA scales were more likely to report satisfaction with the overall appearance of their skin (P < 0.001). Conclusions Both one- and two-grade improvements in facial erythema assessed by subjects (PSA) and clinicians (CEA) correlate well with PAA, a patient-centered representation of meaningful change. © 2014 European Academy of Dermatology and Venereology.

Moore A.,Arlington Center for Dermatology | Kempers S.,Minnesota Clinical Study Center | Murakawa G.,Dermcenter PC | Weiss J.,Gwinnett Clinical Research | And 4 more authors.
Journal of Drugs in Dermatology | Year: 2014

Once-daily topical brimonidine tartrate (BT) gel 0.5% was shown to be efficacious and safe for the treatment of erythema of rosacea in previous studies including a 4-week treatment phase. In the present 1-year study, we aimed to assess the long-term safety and efficacy of the treatment. Subjects with moderate to severe erythema of rosacea were instructed to apply topical BT gel 0.5% once daily for 12 months. Severity of erythema and adverse events (AEs) were evaluated. Approximately 345 subject years of exposure to BT gel 0.5% was achieved in the study. The incidence of AEs and AEs judged to be related to the study drug was higher at the beginning and decreased over the course of the study. Similar safety profiles were observed between the subjects who had received or not received concomitant therapies for the inflammatory lesions of rosacea. Effect of topical BT gel 0.5% on erythema severity was observed after the first application and the durability of the effect was maintained until the end of the study at month 12, with no tachyphylaxis observed. In conclusion, once-daily topical BT gel 0.5% is safe and consistently effective for the long-term treatment of moderate to severe erythema of rosacea, even in the presence of concomitant therapies for the inflammatory lesions of rosacea. Copyright © 2014 Journal of Drugs in Dermatology.

Drouet F.,University of Auckland | Noisier A.F.M.,University of Auckland | Harris C.S.,Galderma RandD | Furkert D.P.,University of Auckland | Brimble M.A.,University of Auckland
European Journal of Organic Chemistry | Year: 2014

Due to their numerous applications, fluorinated amino acids have recently attracted significant attention. The preparation of fluorine-containing phenylalanines, heteroaryl alanines and aliphatic fluorinated amino acids using Mitsunobu-Tsunoda alkylation of a chiral nucleophilic glycine equivalent with readily available alcohol substrates is described. The reaction proceeds in high yields and with excellent diastereoselectivity. This method provides an efficient synthetic route to fluorinated amino acids for which asymmetric approaches are scarce. The asymmetric synthesis of fluorinated amino acids using readily available fluoro alcohols was accomplished by Mitsunobu-type alkylation of a chiral glycine template. This approach accesses fluorinated and trifluoromethylated (hetero)aryl alanines and provides a general method for preparation of amino acids bearing linear fluorinated or trifluoromethylated side-chains. Copyright © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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