If a subject had a worsening score from baseline for any of the tolerability signs (Objective or Subjective), the score was classified as an Adverse Reaction and it was recorded as an Adverse Event.
STATISTICAL ANALYSIS AND METHODOLOGY
All statistical tests of the hypothesis utilized a level of significance of 0.05, and no adjustments were made for the number of tests performed. With lesion counts, analyses were conducted for each lesion type and for totals of lesions. Analyses of lesion counts, IGA, objective (investigator) tolerability, and subjective (participant) tolerability used descriptive statistics that included mean and standard deviation; change-from-baseline analyses used the Wilcoxon signed-rank test, mean percent improvement from baseline, and percent of participants improving. Statistical analysis of the subjective self-perception questionnaire included frequency distributions of scores and analyzed within treatment using top box analysis.
STUDY OUTCOMES
Efficacy Assessment
Lesion count reductions of inflammatory lesions, noninflammatory lesions, and total AV lesions demonstrated significant improvement in mean lesion count scores across all time points compared to baseline. The percentage of participants who improved from baseline are also depicted in Figure 2A-C. With IGA study assessments over time, changesin mean score and the percentage of participants improved from baseline are depicted in Figure 3. Multiple photographic examples are also shown demonstrating individual case results at baseline and weeks 4, 8, and 12 (Figure 4).
Tolerability Assessment
Analysis of mean objective (investigator) tolerability scores showed a slight decrease in erythema at week 4, a slight increase at week 8, and a slight decrease at week 12. None of these changes were statistically significant. There was no edema observed at any time point and mean dryness scores showed a slight decrease over 12 weeks (not statistically significant). Mean scores for peeling remained stable throughout the study. Overall, no significant increase in scores for worsening in erythema, edema, dryness, and peeling were noted indicating favorable tolerability with the skincare regimen.
Analysis of subjective (participant) tolerance scores for itching, burning, and stinging showed no statistically significant changes from baseline for all timepoints. There were individual instances of mild subjective tolerability issues noted: four participants reported itching at the week- 4 timepoint (all mild) only and 1 participant reported itching at weeks 8 and 12. Burning and stinging were not reported by any participants at any timepoints. These data support
Lesion count reductions of inflammatory lesions, noninflammatory lesions, and total AV lesions demonstrated significant improvement in mean lesion count scores across all time points compared to baseline. The percentage of participants who improved from baseline are also depicted in Figure 2A-C. With IGA study assessments over time, changesin mean score and the percentage of participants improved from baseline are depicted in Figure 3. Multiple photographic examples are also shown demonstrating individual case results at baseline and weeks 4, 8, and 12 (Figure 4).
Tolerability Assessment
Analysis of mean objective (investigator) tolerability scores showed a slight decrease in erythema at week 4, a slight increase at week 8, and a slight decrease at week 12. None of these changes were statistically significant. There was no edema observed at any time point and mean dryness scores showed a slight decrease over 12 weeks (not statistically significant). Mean scores for peeling remained stable throughout the study. Overall, no significant increase in scores for worsening in erythema, edema, dryness, and peeling were noted indicating favorable tolerability with the skincare regimen.
Analysis of subjective (participant) tolerance scores for itching, burning, and stinging showed no statistically significant changes from baseline for all timepoints. There were individual instances of mild subjective tolerability issues noted: four participants reported itching at the week- 4 timepoint (all mild) only and 1 participant reported itching at weeks 8 and 12. Burning and stinging were not reported by any participants at any timepoints. These data support
