the adolescent males were much lower than those seen in the adult male population (7.3, 5.8, 5.7, and 7.6) treated with tazarotene 0.045% lotion (Figure 4). Only the change in acne symptom score was statistically significant (P=0.029).
Overall, 13.6% (N=11) of adult male subjects and 21.4% (N=39) adolescent male subjects treated with tazarotene 0.045% lotion reported AEs (Table 2). The majority were mild and there were no severe or serious AEs reported in the adult male population. There was one serious AE reported in the adolescent male population. Only one AE (1.2%) with tazarotene 0.045% lotion in adult males was considered treatment-related AEs (application site pain), compared with 11 (8.0%) in the adolescent males.
Cutaneous Safety and Tolerability
There were slight transient increases in mean severity scores for scaling (from week 2 in both groups) and erythema (from week 2 in the adolescent males). Over the 12-week treatment period, no score was greater than 0.4 (where 1=mild), with similar severity at the end of the study compared with baseline (Figure 5). Hyper- and hypopigmentation was rare at baseline, and throughout the study period.
A post hoc analysis on the treatment of moderate-to-severe acne with the fixed combination clindamycin (1.2%)/benzoyl peroxide