Comparison of the efficacy and safety of a combination topical gel formulation of benzoyl peroxide and clindamycin with benzoyl peroxide, clindamycin and vehicle gel in the treatments of acne vulgaris.
BACKGROUND
Topical clindamycin and benzoyl peroxide have each demonstrated clinical efficacy in the treatment of acne vulgaris. When used in combination, they promise greater efficacy than either individual agent used alone and the combined use of benzoyl peroxide with topical antibacterial has been shown to decrease the emergence of antibacterial resistant species.


OBJECTIVE
The objective was to determine the efficacy and safety of a combination benzoyl peroxide plus clindamycin in a gel formulation compared with each of its 2 active constituents in gel vehicle, and gel vehicle given alone in the treatment of acne vulgaris.


METHODS
In this 10-week, multicenter, double-blind trial, 480 patients with moderate to moderately severe acne were randomized to receive twice-daily treatment with 5% benzoyl peroxide plus 1% clindamycin, 5% benzoyl peroxide, 1% clindamycin, or vehicle.


RESULTS
Significantly greater reductions in the number of inflammatory and total lesions were demonstrated in patients using combination therapy compared with those using any of its 3 individual components. Likewise, both physicians' and patients' global evaluations showed significantly greater improvements with the combination therapy than with its individual components. The most frequent adverse effect, dry skin, occurred to a similar extent in the combination and benzoyl peroxide treatment groups.


CONCLUSIONS
The improved efficacy obtained with the combination therapy was accompanied by a tolerability profile similar to that of benzoyl peroxide alone, making this new combination product an alternative antimicrobial therapy for acne vulgaris.
Leyden
J J
JJ
Department of Dermatology, University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA.
Berger
R S
RS
Dunlap
F E
FE
Ellis
C N
CN
Connolly
M A
MA
Levy
S F
SF
D000152:Acne Vulgaris / Q000188:drug therapy*; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D001585:Benzoyl Peroxide / Q000009:adverse effects* / Q000627:therapeutic use*; D002981:Clindamycin / Q000009:adverse effects* / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D014677:Pharmaceutical Vehicles / Q000627:therapeutic use; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D005782:Gels; D014677:Pharmaceutical Vehicles; D002981:Clindamycin; D001585:Benzoyl Peroxide