AZELAIC ACID 20-PERCENT CREAM IN THE TREATMENT OF FACIAL HYPERPIGMENTATION IN DARKER-SKINNED PATIENTS

This multicenter, randomized, double-masked, parallel-group study asse ssed the efficacy, safety, and tolerability of azelaic acid 20% cream compared with those of its vehicle for the treatment of facial hyperpi gmentation in darker-skinned patients (phototypes IV to VI). Following a 24-week treatment period, azelaic acid produced significantly great er decreases in pigmentary intensity than did vehicle as measured by b oth an investigator's subjective scale (P = 0.021) and a chromometer a nalysis (P = 0.039). There was a significantly greater global improvem ent with azelaic acid than with vehicle at week 24 (P = 0.008). Azelai c acid produced a slightly but significantly greater amount of burning (weeks 4 and 12, P less than or equal to 0.046) and stinging (week 4, P = 0.002) than did vehicle. At the end of the study, more patients t reated with azelaic acid than with vehicle reported having much smooth er skin and being very satisfied or satisfied with their treatment. Al so, more patients treated with azelaic acid than with vehicle rated th eir medication as being more effective or the same as past treatments. Thus azelaic acid is an effective and well-tolerated treatment for hy perpigmentation in darker-skinned patients.