Ortho Retin-A Micro clears FDA Feb. 7 for acne use; labeling cites 3% rate of severe skin irritation.
Executive Summary
ORTHO RETIN-A MICRO SEVERE SKIN IRRITATION RATE OF 3% was seen in clinical trials of the new formulation of the anti-acne agent tretinoin, according to product labeling. Labeling also indicates that 6% of patients dropped out of clinical trials as a result of skin irritation. "No more than 3% of patients had scores indicative of a severe irritation rating, although 6% (14/224) of patients treated with Retin-A Micro (tretinoin gel microsphere .1%) discontinued treatment due to irritation," labeling states.