Secondary endpoints consisted of statistically significant improvement at week 12 in clinical features of rosacea such as flushing, erythema, papules and pustules, telangiectasia, burning or stinging, plaques, dry appearance, edema, ocular symptoms, peripheral location, phymatous changes. Additional secondary endpoints included improvements in physician global assessments regarding the following rosacea subtypes: erythematotelangiectatic, papulopustular, phymatous; improvements in subject self-assessments; statistically significant improvements in standard tolerability features of scaling, dryness and erythema; and statistically significant differences in the nature and severity of adverse events between CT and placebo groups at week 12.
Eighty-three subjects enrolled in the study, with 43 subjects allocated to CT group and 40 to placebo group (Figure 1). The average age of the study subjects was in the early 50s and about two-thirds of the subjects were female. As indicated in Table 1, there were no statistically significant differences at baseline between the CT and placebo groups with regard to age and sex distribution. Similarly, there was no difference in rosacea disease severity as measured by papule/pustule count at baseline.
Of the 83 study subjects enrolled, 73 subjects (88%) completed all study visits. In the CT group there was one early termination due to irritation from CT gel, and one due to worsening rosacea. In the placebo group, one subject withdrew participation because of irritant dermatitis. One subject in the CT group was lost to follow-up, while two subjects in the placebo group were lost to follow-up, for unknown reasons. Three patients were excluded from the mITT analysis because they did not complete at least one follow-up visit.
Primary and Secondary Endpoints
As indicated in Table 2, there were no significant differences in absolute papule/pustule count after 12 weeks in either the CT (P=0.63) or placebo groups (P=0.15). The percentage of sub-