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 2: Physician assessed local cutaneous irritation with DIFFERIN Gel

Table 3: Patient reported local cutaneous adverse events with DIFFERIN Gel

Related adverse events 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 events 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 events was similar to the 12-week controlled study.

As DIFFERIN Gel, 0.3% has the potential to induce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with DIFFERIN Gel, 0.3%. If these preparations have been used, it is advisable not to start therapy with DIFFERIN Gel, 0.3%, until the effects of such preparations have subsided.

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