Efficacy and tolerability of a fixed combination of clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel in moderate or severe acne subpopulations.
BACKGROUND
Oral antibiotics are commonly prescribed for moderate or severe acne, but there may be limitations due to concerns about side effects associated with systemic treatments.


OBJECTIVE
To evaluate the efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BP 2.5%) aqueous gel in the treatment of moderate or severe acne subpopulations.


METHODS
Two multicenter, double-blind studies randomized 2,813 subjects with moderate or severe acne to clindamycin-BP 2.5% gel, each active ingredient, or vehicle gel, once daily for 12 weeks. Efficacy evaluations included inflammatory and non-inflammatory lesion counts and evaluator's global severity score at baseline and weeks 4, 8 and 12. Adverse events and subjects' evaluations of product tolerability were also monitored. Subpopulation efficacy and safety analyses by baseline acne severity were performed for the combined data from the two phase 3 studies.


RESULTS
Clindamycin-BP 2.5% gel significantly reduced inflammatory, non-inflammatory and total lesions compared with each active ingredient and vehicle in subjects with moderate acne and compared with vehicle in severe acne subjects at week 12. Significant improvements in evaluator's global severity score were evident for subjects with moderate acne in the clindamycin-BP 2.5% group compared with each active ingredient and vehicle and compared with vehicle in subjects with severe acne at week 12. Rates of adverse events were low and similar between treatment groups and baseline acne severity.


CONCLUSIONS
Clindamycin-BP 2.5% aqueous gel is an effective and safe once-daily treatment for moderate or severe acne.
Webster
Guy
G
Jefferson Dermatology Service, Wilmington Department of Veterans Affairs Medical Center, Wilmington, PA, USA.
Rich
Phoebe
P
Gold
Michael H
MH
Mraz
Serena
S
Calvarese
Barry
B
Chen
Diana
D
D000152:Acne Vulgaris / Q000188:drug therapy*; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D001585:Benzoyl Peroxide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002981:Clindamycin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D002981:Clindamycin; C007084:clindamycin phosphate; D001585:Benzoyl Peroxide