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

eters compared to the placebo group. However, none of the individual survey items reached statistical significance in the CT compared with placebo group.

As indicated in Table 5, CT gel was well-tolerated by subjects in the CT group. Scaling, dryness and erythema were not significantly worse or better in the CT versus placebo group at week 12.

There were no serious adverse events in either the CT or placebo groups. Table 6 shows adverse events that were observed more than once in the CT or placebo groups. None were statistically significant between CT or placebo groups except for facial scaling, which was increased in the CT group, as would be expected since the CT gel included tretinoin.

CT gel may reduce the visible appearance of telangiectasias of rosacea, a finding that clearly merits further study through studies with larger sample size. If confirmed, this finding would fill a critical need in the topical armamentarium for rosacea. For instance, a 2009 Cochrane Collaboration review of topical interventions for rosacea showed only one randomized placebo controlled trial with improvements in telangiectasia.¹⁴ That study utilized 1% metronidazole cream with SPF 15 sunscreen.¹⁵ Per the www.clinicaltrials.gov website, studies using topical alpha-1 agonists for erythema and/or telangiectatic component of facial rosacea are ongoing.

We had expected that CT gel would improve the papulopustular component of rosacea, given its proven efficacy to eradicate papules in acne vulgaris. It may be possible that as the erythematotelangiectatic subtype of rosacea for some subjects improved, their papules could be more readily detected.

Although rosacea patients are anecdotally thought to possess sensitivity to topical agents such as tretinoin, CT gel was well tolerated compared to the placebo gel. While CT gel did lead to more patient reports of facial scaling than placebo gel during the course of the study, this side effect was not reported more often as the reason for discontinuing the study. Furthermore, there were no differences in scaling that could be detected by the physician assessment at 12 weeks between the two groups.

Finally, the mechanism by which CT gel might contribute to reduced appearance of telangiectasias merits further study. It is possible that telangiectasias are less visible because clindamycin is an anti-microbial agent that leads to decreased inflammation. Another mechanism might be that tretinoin decreases the visibility of telangiectasias by inducing collagen formation in the upper dermis or via proliferation of keratinocytes,^7,8 both of which might obscure the appearance of telangiectasias.

This study was funded by a grant from Medicis. The authors have no conflict of interest to disclose. This work was accepted as a poster abstract to the 2011 Summer American Academy of Dermatology meeting.