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

March 2012 | Volume 11 | Issue 3 | Original Article | 333 | Copyright © March 2012


table 2
paramjects with decreased papule/pustule count was not statistically significant between the treated and the placebo group at week 12. The across-group comparisons of mean change in papule/pustule count after 12 weeks for CT and placebo were non-significant (P=0.15). The across-group comparisons of percentage of subjects with improvement after 12 weeks between CT and placebo were non-significant (P=0.20).
Table 3 depicts the results of physician-assessed primary features of rosacea after 12 weeks. There was a trend towards significance in CT versus placebo group with respect to improvements in telangiectasia (P=0.06), with odds ratio (OR) 3.157 and 95% confidence interval [1.003-9.934], and erythematotelangiectatic subtype of rosacea (P=0.05), with OR 3.6207 and 95% confidence interval [1.054-12.437]. Figure 2 depicts a subject with reduction of telangiectasia and erythematotelangiectatic rosacea subtype severity after 12 weeks. Neither telangiectasia nor erythematotelangiectasia severity was significantly different at baseline between the CT and placebo groups. One unexpected significant finding was that placebo subjects showed statistically significant improvements in edema (P=0.03) at 12 weeks, while CT group did not. None of the other physician-assessed clinical features of rosacea reached statistical significance.
Table 4 shows the results of subjects' self-assessments of rosacea severity. In particular, this table indicates that the CT group showed more improvement at 12 weeks on almost all param-