A COMPARISON OF THE EFFICACY AND SAFETY OF ADAPALENE GEL 0.1-PERCENT AND TRETINOIN GEL 0.025-PERCENT IN THE TREATMENT OF ACNE-VULGARIS - A MULTICENTER TRIAL

Background: Adapalene is a new synthetic retinoid analogue developed f or the topical treatment of acne vulgaris. Objective: The study was de signed to compare the efficacy and safety of adapalene gel 0.1% with t retinoin gel 0.025% in the treatment of grade II to III facial acne vu lgaris. Methods: Three hundred twenty-three patients were enrolled in this investigator-masked randomized, parallel group, multicenter trial . Patients applied the test materials to the entire facial area daily, for a period of 12 weeks. Efficacy rind cutaneous tolerance were asse ssed at baseline and weeks 2, 4, 8, and 12. Efficacy was determined by investigator counts of noninflammatory open and closed comedones, and inflammatory papules and pustules, as well as global improvement. Cut aneous tolerance was evaluated by erythema, scaling, and dryness, alon g with burning and pruritus. Results: Starting at weeks 2 and 4, adapa lene gel produced numerically greater lesion reductions than did treti noin gel for all lesion types. At week 12, the mean percent reduction in the different lesion counts was as follows: 49% versus 37% for tota l lesions (p < 0.01); 46% versus 33% for noninflammatory lesions (p = 0.02); 48% versus 38% for inflammatory lesions (p = 0.06) in adapalene and tretinoin gel treatment groups, respectively. Cutaneous side effe cts were limited to a mild ''retinoid dermatitis'' occurring in both t reatment groups; however, patients treated with adapalene gel tolerate d this therapy significantly better than those treated with tretinoin gel. Laboratory test evaluations (hematology, blood chemistries, urina lysis) were performed in 54 patients before and after 3 months of trea tment. No clinically significant changes were observed. Conclusion: Ad apalene gel 0.1% applied once daily was significantly more effective i n reducing acne lesions and was better tolerated than tretinoin gel 0. 025% in the treatment of acne vulgaris.