View this table | Table 2. Irritation Classification* |
results Of the 42 subjects enrolled, 38 subjects (90.5%) completed the study. Demographic data are presented in Table 3. Results are summarized in Table 4 and Figure 1. Figure 2 shows a clinical photograph of typical irritation observed during the study.
View this table | Table 3. Demographic Data |
View this table | Table 4. Summary of Mean Cumulative Irritancy Index (MCII) Statistical Comparisons |
In the study, the reasons for treatment discontinuation were not always due to an erythema score of 3 but also because of other clinical aspects of severe intolerance, such as epidermal peeling with subsequent superficial erosion (without severe erythema). Figure 3 shows the number of subjects who discontinued wearing the patches due to an irritation score of 3.
Adapalene gel and solution 0.1% were each significantly less irritating during sustained use than tazarotene gels 0.05% and 0.1%, tretinoin microsphere gel 0.1%, and tretinoin cream 0.025%. Although tretinoin gel 0.1% MCII was numerically superior to both adapalene gel and solution MCIIs, no statistically significant difference could be depicted between the 3 products. Repeated applications of adapalene gel or solution resulted in levels of irritation that were not significantly different from the white petrolatum control. back to top