Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reactions 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.
In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne patients who used DIFFERIN Gel, 0.3% once daily for 12 weeks. Of the patients who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter. The incidence of local cutaneous irritation with DIFFERIN Gel, 0.3% from the controlled clinical study is provided in the following table:
Table 1: Physician assessed local cutaneous irritation with DIPPERIN Gel
| Incidence of Local Cutaneous Irritation with DIFFERIN Gel, 0.3% from Controlled Clinical Study (N = 253*) Maximum Severity Scores Higher Than Baseline |
|||
| Mild | Moderate | Severe | |
| Erythema | 66 (26.1%) | 33 (13.0%) | 1 (0.4%) |
| Scaling | 110 (43.5%) | 47 (18.6%) | 3 (1.2%) |
| Dryness | 113 (44.7%) | 43 (17.0%) | 2 (0.8%) |
| Burning/Stinging | 72 (28.5%) | 36 (142%) | 9 (3.6%) |
| * Total number of subjects with local cutaneous data for at least one post-Baseline evaluation. | |||
Table 2: Patient reported local cutaneous adverse reactions with DIFFERIN Gel
| DIFFERIN (adapalene) Gel, 0.3% | Vehicle Gel | |
| N=258 | N=134 | |
| Related* Adverse Reactions | 57(22.1%) | 6 (4.5%) |
| Dry Skin | 36(14%) | 2(1.5%) |
| Skin Discomfort | 15(5.8%) | 0 (0.0%) |
| Desquamation | 4(1.6%) | 0 (0.0%) |
| * Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related | ||
Related adverse reactions from the controlled clinical trial that occurred in greater than 1% of patients who used DIFFERIN Gel, 0.3% once daily included: dry skin (14.0%), skin discomfort (5.8%), pruritus (1.9%), desquamation (1.6%), and sunburn (1.2%). The following selected adverse reactions occurred in less than 1% of patients: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.
In a one-year, open-label safety study of 551 patients with acne who received DIFFERIN Gel, 0.3%, the pattern of adverse reactions was similar to the 12-week controlled study.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of adapalene: skin irritation, application site pain, face edema, eyelid edema, lip swelling, and angioedema. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drag exposure.