Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. A total of 2141 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks. Of these, 1068 were exposed to DIFFERIN Lotion during the clinical trials. A total of 1057 subjects completed at least one post treatment evaluation. Related adverse reactions that were reported in at least 1% of subjects treated with DIFFERIN Lotion or with the Vehicle Lotion are presented in Table 1. The majority of cases were transient, mild to moderate in severity and were managed with moisturizers.
Table 1: Adverse Reactions Reported in Clinical Trials by At Least 1% of Subjects
|System Organ Class/ Preferred Term||Adapalene Lotion 0.1%
N = 1068
N = 1073
|Subjects with Related AR(s)||10.20%||4.60%|
|Skin burning/skin discomfort||0.90%||0.00%|
Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials. Erythema, scaling, dryness, burning/stinging were assessed:
Table 2: Incidence of Local Cutaneous Irritation, for Subjects Whose Irritation Score was Higher than at Baseline, in Controlled Clinical Trials Adverse Reactions (DIFFERIN Lotion Group N = 1057*)
|Combined Trial 1 and Trial 2||Maximum Severity During Treatment (N = 1057)||Week 12 Treatment Severity (N = 950)|
|Local Cutaneous Irritation (skin irritation)||Mild||Moderate||Severe||Mild||Moderate||Severe|
|* Data from 11 subjects with missing data are not included.|
Local tolerability scores for erythema, scaling, dryness, burning/stinging rose during the first two weeks of treatment and generally decreased thereafter.
In an open label postmarketing pharmacokinetic trial of 13 adolescent subjects, the adverse event of pruritus was reported in 8 out of 13 subjects.