A randomized, double-blind, placebo-controlled, pilot study to assess the
efficacy and safety of clindamycin 1.2% and tretinoin 0.025% combination gel for
the treatment of acne rosacea over 12 weeks.
Author(s): Chang AL, Alora-Palli M, Lima XT, Chang TC, Cheng C, Chung CM, Amir O, Kimball
AB.
Affiliation(s): Stanford University School of Medicine, Redwood City, CA, USA.
Publication date & source: 2012, J Drugs Dermatol. , 11(3):333-9
BACKGROUND: Papulopustular acne rosacea is a chronic inflammatory condition which
can be difficult to treat. Many patients are unwilling to use systemic
medications, and single topical agents alone may not address all the symptoms of
rosacea. A combination topical clindamycin phosphate 1.2% and tretinoin 0.025%
gel is efficacious for acne vulgaris, and may be helpful for rosacea, since acne
vulgaris and rosacea shares many similar clinical and histologic features.
OBJECTIVE: To assess the preliminary efficacy and safety of a combination gel
consisting of clindamycin phosphate 1.2% and tretinoin 0.025% on papulopustular
rosacea after 12 weeks of usage.
METHODS: Randomized, double-blind, placebo controlled two site study of 79
participants with moderate to severe papulopustular acne rosacea using both
physician and subjects' validated assessment tools. Primary endpoint consisted of
statistically significant reduction in absolute papule or pustule count after 12
weeks of usage.
RESULTS: There was no significant difference in papule/pustule count between
placebo and treated groups after 12 weeks (P=0.10). However, there was nearly
significant improvement in physicians' assessments of the telangiectasia
component of rosacea (P=0.06) and erythematotelangiectatic rosacea subtype
(P=0.05) in treated versus placebo group after 12 weeks. The only significant
adverse event different was facial scaling, which was significantly increased in
treated group (P=0.01), but this did not result in discontinuation of study drug.
CONCLUSIONS: A combination gel of clindamycin phosphate 1.2% and tretinoin 0.025%
may improve the telangiectatic component of rosacea and appears to better treat
the erythemotelangiectatic subtype of rosacea rather than papulopustular subtype.
Our preliminary study suggests that future studies with much larger sample size
might confirm our findings.
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