pected applications while enrolled in the study, was summarized
using descriptive statistics. Cutaneous safety and tolerability assessments
were also summarized using descriptive statistics.
AEs were recorded and classified using the Medical Dictionary
for Regulatory Activities (MedDRA) terminology. Imputations
were not made for missing safety data.
RESULTS
Participant Disposition and Demographics
A total of 1,614 participants were randomized in the two phase 3 studies. For the post hoc analysis, 1,064 females and 550 males were included in the ITT population; 1,032 females and 538 males comprised the safety population. In the randomized population, 86% of female participants and 91% of male participants completed the study. The most common reasons for discontinuation were lost to follow-up (females: n=77; males: n=24), participant request (females: n=40; males: n=17), or adverse event (females: n=21; males: n=2). Most participants (>88%) were compliant with tazarotene 0.045% or vehicle treatment. A higher percentage of male participants were compliant with vehicle relative to tazarotene (96.6% and 89.3%, respectively) while female participants had similar rates of compliance with both treatments (96.3% and 92.9%, respectively).
Baseline demographics and disease characteristics are presented in Table 1. Female participants were 4.5 years older than males on average. More than 85% of both female and male participants had moderate disease (EGSS=3) at baseline; a lower percentage of females reported severe disease (EGSS=4) compared with males.
Efficacy
At week 12, least-squares (LS) mean percent changes from baseline in inflammatory lesion counts were greater with tazarotene 0.045% lotion versus vehicle lotion in females (-60.1% vs -52.1%; P<0.001) and males (-53.6% vs -39.8%; P<0.001; Figure 1). Week 8 results were also statistically significant in both subgroups. At weeks 4 and 12, tazarotene-treated females had a significantly greater mean percent decrease in inflammatory lesions than tazarotene-treated males (P<0.05, both); no difference between the sexes was observed at week 8.
For noninflammatory lesions, results from week 12 indicated a significant difference between tazarotene 0.045% lotion and vehicle in females (-57.6% vs -44.9%; P<0.001) and males (-52.9% vs -36.5%; P<0.001), as did the results from weeks 4 and 8 (Figure 2). At weeks 4, 8, and 12, tazarotene-treated females had a significantly greater mean percent decrease in noninflammatory lesions than tazarotene-treated males (P<0.05, all).
The percentage of participants with treatment success at week 12 was significantly higher with tazarotene 0.045% lotion compared with vehicle lotion in females (33.1% vs 20.6%; P<0.001) and males (25.1% vs 12.8%; P<0.001; Figure 3). A significantly greater percentage of tazarotene-treated female participants achieved treatment success at week 12 versus tazarotene-treated male participants (P<0.05).
Safety
AEs and cutaneous safety and tolerability for the overall pooled population have been previously reported.16 In this analysis, rates
A total of 1,614 participants were randomized in the two phase 3 studies. For the post hoc analysis, 1,064 females and 550 males were included in the ITT population; 1,032 females and 538 males comprised the safety population. In the randomized population, 86% of female participants and 91% of male participants completed the study. The most common reasons for discontinuation were lost to follow-up (females: n=77; males: n=24), participant request (females: n=40; males: n=17), or adverse event (females: n=21; males: n=2). Most participants (>88%) were compliant with tazarotene 0.045% or vehicle treatment. A higher percentage of male participants were compliant with vehicle relative to tazarotene (96.6% and 89.3%, respectively) while female participants had similar rates of compliance with both treatments (96.3% and 92.9%, respectively).
Baseline demographics and disease characteristics are presented in Table 1. Female participants were 4.5 years older than males on average. More than 85% of both female and male participants had moderate disease (EGSS=3) at baseline; a lower percentage of females reported severe disease (EGSS=4) compared with males.
Efficacy
At week 12, least-squares (LS) mean percent changes from baseline in inflammatory lesion counts were greater with tazarotene 0.045% lotion versus vehicle lotion in females (-60.1% vs -52.1%; P<0.001) and males (-53.6% vs -39.8%; P<0.001; Figure 1). Week 8 results were also statistically significant in both subgroups. At weeks 4 and 12, tazarotene-treated females had a significantly greater mean percent decrease in inflammatory lesions than tazarotene-treated males (P<0.05, both); no difference between the sexes was observed at week 8.
For noninflammatory lesions, results from week 12 indicated a significant difference between tazarotene 0.045% lotion and vehicle in females (-57.6% vs -44.9%; P<0.001) and males (-52.9% vs -36.5%; P<0.001), as did the results from weeks 4 and 8 (Figure 2). At weeks 4, 8, and 12, tazarotene-treated females had a significantly greater mean percent decrease in noninflammatory lesions than tazarotene-treated males (P<0.05, all).
The percentage of participants with treatment success at week 12 was significantly higher with tazarotene 0.045% lotion compared with vehicle lotion in females (33.1% vs 20.6%; P<0.001) and males (25.1% vs 12.8%; P<0.001; Figure 3). A significantly greater percentage of tazarotene-treated female participants achieved treatment success at week 12 versus tazarotene-treated male participants (P<0.05).
Safety
AEs and cutaneous safety and tolerability for the overall pooled population have been previously reported.16 In this analysis, rates
