Efficacy and safety of clindamycin phosphate 1.2%/tretinoin 0.025% formulation for the treatment of acne vulgaris: pooled analysis of data from three randomised, double-blind, parallel-group, phase III studies.
BACKGROUND
The efficacy and safety of clindamycin phosphate 1.2%/tretinoin 0.025% (Clin-RA) were evaluated in three 12-week randomised studies.


OBJECTIVE
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.


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.


CONCLUSIONS
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.
Dept of Dermato-Cancerology, University of Nantes, Place Alexis Ricordeau, 44093, Nantes, France.
Brigitte
B
Dréno
Dept of Medical Sciences, Section of Dermatology Azienda Ospedaliera Universitaria of Ferrara, Corso Giovecca 203, 44100 Ferrara, Italy.
Vincenzo
V
Bettoli
Clinic for Dermatology, Venereology and Allergy, University Hospital, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany.
Falk
F
Ochsendorf
Dept of Dermatology, Harrogate & District NHS Foundation Trust, Lancaster Park Road, Harrogate, HG2 7SX, UK.
Alison M
AM
Layton
Dept of Dermatology, Clínica Dermatológica de Moragas, Balmes 195, 08006 Barcelona, Spain.
Montserrat
M
Perez
Meda Pharma GmbH & Co. KG, Benzstrasse 1, 61353 Bad Homburg, Germany.
Rada
R
Dakovic
Dept of Dermatology & Venereology, Otto-von-Guericke University of Magdeburg, Universitätsplatz 2, 39106 Magdeburg, Germany.
Harald
H
Gollnick
D000152:Acne Vulgaris / Q000188:drug therapy; D000293:Adolescent; D002648:Child; D002981:Clindamycin / Q000009:adverse effects / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D014212:Tretinoin / Q000009:adverse effects / Q000627:therapeutic use*
D003879:Dermatologic Agents; D004338:Drug Combinations; C117880:clindamycin, tretinoin drug combination; D002981:Clindamycin; D014212:Tretinoin
acne vulgaris; clindamycin phosphate; combination therapy; pooled analysis; tretinoin