treatment group and analysis center. Values were adjusted for multiple imputations. Descriptive statistics were used to summarize the results of the Acne-QoL questionnaire. In subjects who discontinued treatment before Week 12 or missed visits between baseline and final evaluation, the last observation was carried forward. All statistical analyses were conducted using SAS® version 9.3 or later. Statistical significance was based on 2-tailed tests of the null hypothesis resulting in P values of 0.05 or less. All AEs occurring during the studies were recorded and classified on the basis of medical dictionary for drug regulatory activities terminology (MedDRA) for the safety population.
Study Assessment
Efficacy
Co-primary endpoints were EGSS and absolute reduction in inflammatory lesion and noninflammatory lesion counts. Percent of subjects who had at least a 2-grade reduction from baseline EGSS at week 12, and an EGSS of ‘clear’ or ‘almost clear’ were considered a treatment success. Additional assessments included percent change in inflammatory and noninflammatory lesion counts from baseline at each study visit and absolute change in Acne-QoL domain scores.
Safety
Safety evaluations, including AEs, cutaneous safety evaluations and tolerability, vital signs, laboratory evaluations, and physical examinations were performed; information on reported and observed AEs obtained at each visit, cutaneous safety, and tolerability at each study visit.
Cutaneous safety (individual assessments of scaling, erythema, hypopigmentation, and hyperpigmentation at the drug application site) was reported by the investigator/evaluator at all postscreening study visits using a 4-point scale, where 0=none and 3=severe. Tolerability (individual assessments of itching, burning, and stinging) was reported by the subjects at all postscreening study visits. Subjects were asked to provide an average evaluation of each parameter over the period since the previous study visit using a 4-point scale, where 0=none and 3=severe.
Vital sign measurements were recorded, blood samples collected, and an abbreviated physical examination performed at baseline and week 12. A medical history was taken at screening, and confirmed and revised at baseline, if necessary.
Study Assessment
Efficacy
Co-primary endpoints were EGSS and absolute reduction in inflammatory lesion and noninflammatory lesion counts. Percent of subjects who had at least a 2-grade reduction from baseline EGSS at week 12, and an EGSS of ‘clear’ or ‘almost clear’ were considered a treatment success. Additional assessments included percent change in inflammatory and noninflammatory lesion counts from baseline at each study visit and absolute change in Acne-QoL domain scores.
Safety
Safety evaluations, including AEs, cutaneous safety evaluations and tolerability, vital signs, laboratory evaluations, and physical examinations were performed; information on reported and observed AEs obtained at each visit, cutaneous safety, and tolerability at each study visit.
Cutaneous safety (individual assessments of scaling, erythema, hypopigmentation, and hyperpigmentation at the drug application site) was reported by the investigator/evaluator at all postscreening study visits using a 4-point scale, where 0=none and 3=severe. Tolerability (individual assessments of itching, burning, and stinging) was reported by the subjects at all postscreening study visits. Subjects were asked to provide an average evaluation of each parameter over the period since the previous study visit using a 4-point scale, where 0=none and 3=severe.
Vital sign measurements were recorded, blood samples collected, and an abbreviated physical examination performed at baseline and week 12. A medical history was taken at screening, and confirmed and revised at baseline, if necessary.
RESULTS
Subject Disposition
Overall, 1614 subjects were randomized to tazarotene 0.045% lotion or vehicle lotion and included in the ITT population (Figure 1). Across the two studies, 86.6% (N=799) and 88.6% (N=815) of subjects treated with tazarotene 0.045% lotion or vehicle completed. Main reasons for study discontinuation with tazarotene 0.045% lotion were lost to follow-up (5.6%, N=45), subject request (4.3%, N=34), or adverse events (2.4%, N=19). Lost to follow-up (6.9%, N=56) and subject request (2.8%, N=23) were also the main reasons for discontinuation in the vehicle arms. A total of 1570 subjects were included in the safety population, (44 subjects were not included due to no post baseline safety evaluation).
Demographics and Baseline Characteristics
Demographic data were comparable across the two studies (Table 1). Mean age was 20.6 (SD 7.11) in Study 1 and 20.3 (SD 6.65) in Study 2. Overall, the majority of subjects were female (65.9%, N=1064) and Caucasian (73.8%, N=1191).
Overall, 1614 subjects were randomized to tazarotene 0.045% lotion or vehicle lotion and included in the ITT population (Figure 1). Across the two studies, 86.6% (N=799) and 88.6% (N=815) of subjects treated with tazarotene 0.045% lotion or vehicle completed. Main reasons for study discontinuation with tazarotene 0.045% lotion were lost to follow-up (5.6%, N=45), subject request (4.3%, N=34), or adverse events (2.4%, N=19). Lost to follow-up (6.9%, N=56) and subject request (2.8%, N=23) were also the main reasons for discontinuation in the vehicle arms. A total of 1570 subjects were included in the safety population, (44 subjects were not included due to no post baseline safety evaluation).
Demographics and Baseline Characteristics
Demographic data were comparable across the two studies (Table 1). Mean age was 20.6 (SD 7.11) in Study 1 and 20.3 (SD 6.65) in Study 2. Overall, the majority of subjects were female (65.9%, N=1064) and Caucasian (73.8%, N=1191).
