visit (±3 days for weeks 4 and 8, ±4 days for week 12, and ±5 days for week 16). In the sensitivity analysis, missing values for a given visit were not imputed, and patients having a visit outside the allowable time window were thrown out of the analysis. Based on these criteria, there were 50, 41, 42, and 40 subjects in the PP population at weeks 4, 8, 12, and 16, respectively.
The sensitivity analysis was conducted by repeating every analysis
conducted on the ITT population in the PP population, and noting changes in the conclusions from the hypothesis tests, ie, whether the null hypothesis was rejected (P<.05). With one exception, the conclusions from the PP analysis corresponded
with those from the ITT analyses (results not shown). The exception was of minor consequence—the week 4 to week 8 change in IGA in the ER minocycline + azelaic acid 15% group was significant in the ITT population (P=.01), but nonsignificant in the PP population (P=.10). We thus conclude that protocol deviations had minimal impact on our results.
Both ER minocycline 45 mg and ER minocycline 45 mg in combination
with 15% azelaic acid provided significant reductions in lesion counts, IGA scores, and CEA scores in patients with rosacea over this 16-week study. Neither study group displayed superior results to the other, as reductions in all measured outcome variables were similar between groups and not statistically
significantly different. The treatment groups did not significantly differ with respect to the incidence of AEs, and a negligible number of AEs were possibly suspected to be related to the study medication. The medications were well tolerated in both groups. This study highlights the benefits of ER minocycline
45 mg in patients with rosacea.
Funding for the study was provided by Medicis. Dr. Jackson has served as a speaker, consultant, and investigator for Medicis.
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J. Mark Jackson MDkmmjackson@aol.com