An observer-blind parallel-group, randomized, multicentre clinical and microbiological study of a topical clindamycin/zinc gel and a topical clindamycin lotion in patients with mild/moderate acne.
BACKGROUND
A topical acne treatment in which clindamycin phosphate equivalent to 1% clindamycin is presented in a gel formulation has received marketing authorizations in a number of EU and non-EU countries. Clindamycin/zinc gel contains zinc acetate in a formulation that reduces systemic absorption of clindamycin through the skin.


OBJECTIVE
To compare the efficacy and safety of a 1% clindamycin/zinc gel when applied to the face once daily or twice daily with a 1% clindamycin lotion applied twice daily for 16 weeks in patients with mild to moderate acne vulgaris.


METHODS
This was a randomized, comparative, observer-blind, parallel-group, multicentre study involving 246 acne patients.


RESULTS
The study demonstrated therapeutic similarity between clindamycin/zinc gel applied once and twice daily with clindamycin lotion applied twice daily. All three regimens produced a gradual and time-dependent reduction in inflamed lesions, non-inflamed lesions and overall grade. Side effects were similar and minimal, consisting predominantly of mild irritant dermatitis. All regimes produced a time-related significant reduction in skin surface and follicular Propionibacterium spp. and Micrococcaceae. The emergence of resistant strains was less than 5% and was similar with all three regimes.


CONCLUSIONS
The equivalent efficacy and safety of clindamycin/zinc gel either once or twice daily to clindamycin lotion twice daily has been demonstrated. It is suggested that a treatment regime of one application per day may significantly enhance compliance and thus treatment success in acne patients.
Cunliffe
W J
WJ
Skin Research Centre, Department of Dermatology, Leeds General Infirmary, UK.
Fernandez
C
C
Bojar
R
R
Kanis
R
R
West
F
F
D000152:Acne Vulgaris / Q000188:drug therapy* / Q000382:microbiology; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D002648:Child; D002981:Clindamycin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D011424:Propionibacterium / Q000302:isolation & purification; D016037:Single-Blind Method; D012867:Skin / Q000382:microbiology; D019345:Zinc Acetate / Q000008:administration & dosage*
D004338:Drug Combinations; D005782:Gels; D002981:Clindamycin; D019345:Zinc Acetate