Brigitte Dréno1, Vincenzo Bettoli2, Falk Ochsendorf3, Alison M Layton4, Montserrat Perez5, Rada Dakovic6, Harald Gollnick7. 1. Dept of Dermato-Cancerology, University of Nantes, Place Alexis Ricordeau, 44093, Nantes, France. 2. Dept of Medical Sciences, Section of Dermatology Azienda Ospedaliera Universitaria of Ferrara, Corso Giovecca 203, 44100 Ferrara, Italy. 3. Clinic for Dermatology, Venereology and Allergy, University Hospital, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany. 4. Dept of Dermatology, Harrogate & District NHS Foundation Trust, Lancaster Park Road, Harrogate, HG2 7SX, UK. 5. Dept of Dermatology, Clínica Dermatológica de Moragas, Balmes 195, 08006 Barcelona, Spain. 6. Meda Pharma GmbH & Co. KG, Benzstrasse 1, 61353 Bad Homburg, Germany. 7. Dept of Dermatology & Venereology, Otto-von-Guericke University of Magdeburg, Universitätsplatz 2, 39106 Magdeburg, Germany.
Abstract
BACKGROUND: The efficacy and safety of clindamycin phosphate 1.2%/tretinoin 0.025% (Clin-RA) were evaluated in three 12-week randomised studies. OBJECTIVES: To perform a pooled analysis of data from these studies to evaluate Clin-RA's efficacy and safety in a larger overall population, in subgroups of adolescents and according to acne severity. MATERIALS & METHODS:4550 patients were randomised to Clin-RA, clindamycin, tretinoin and vehicle. Evaluations included percentage change in lesions, treatment success rate, proportions of patients with ≥50% or ≥80% continuous reduction in lesions, adverse events and cutaneous tolerability. RESULTS: In the overall population, the percentage reduction in inflammatory, non-inflammatory and total lesions and the treatment success rate were significantly greater with Clin-RA compared with clindamycin, tretinoin and vehicle alone (all p<0.01). The percentage reduction in all types of lesions was also significantly greater with Clin-RA in the adolescent subgroup (2915 patients, p<0.002) and in patients with mild/moderate acne (3662 patients, p<0.02) versus comparators. In patients with severe acne (n = 880), the percentage reduction in all lesion types was significantly greater with Clin-RA versus vehicle (p<0.0001). A greater proportion of Clin-RA treated patients had a ≥50% or ≥80% continuous reduction in all types of lesions at week 12 compared with clindamycin, tretinoin and vehicle. Adverse event frequencies in the active and vehicle groups were similar. Baseline-adjusted mean tolerability scores over time were <1 (mild) and similar in all groups. CONCLUSION: Clin-RA is safe, has superior efficacy to its component monotherapies and should be considered as one of the first-line therapies for mild-to-moderate facial acne.
RCT Entities:
BACKGROUND: The efficacy and safety of clindamycin phosphate 1.2%/tretinoin 0.025% (Clin-RA) were evaluated in three 12-week randomised studies. OBJECTIVES: To perform a pooled analysis of data from these studies to evaluate Clin-RA's efficacy and safety in a larger overall population, in subgroups of adolescents and according to acne severity. MATERIALS & METHODS: 4550 patients were randomised to Clin-RA, clindamycin, tretinoin and vehicle. Evaluations included percentage change in lesions, treatment success rate, proportions of patients with ≥50% or ≥80% continuous reduction in lesions, adverse events and cutaneous tolerability. RESULTS: In the overall population, the percentage reduction in inflammatory, non-inflammatory and total lesions and the treatment success rate were significantly greater with Clin-RA compared with clindamycin, tretinoin and vehicle alone (all p<0.01). The percentage reduction in all types of lesions was also significantly greater with Clin-RA in the adolescent subgroup (2915 patients, p<0.002) and in patients with mild/moderate acne (3662 patients, p<0.02) versus comparators. In patients with severe acne (n = 880), the percentage reduction in all lesion types was significantly greater with Clin-RA versus vehicle (p<0.0001). A greater proportion of Clin-RA treated patients had a ≥50% or ≥80% continuous reduction in all types of lesions at week 12 compared with clindamycin, tretinoin and vehicle. Adverse event frequencies in the active and vehicle groups were similar. Baseline-adjusted mean tolerability scores over time were <1 (mild) and similar in all groups. CONCLUSION: Clin-RA is safe, has superior efficacy to its component monotherapies and should be considered as one of the first-line therapies for mild-to-moderate facial acne.
Entities:
Keywords:
acne vulgaris; clindamycin phosphate; combination therapy; pooled analysis; tretinoin
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