Publication:

A comparison study of the clinical efficacy and safety of topical adapalene gel (0.1%) and tretinoin cream (0.025%) in the treatment of acne vulgaris

Background Adapalene a synthetic retinoid analogue, is an addition to the arsenal of topical retinoids developed for the topical treatment of acne vulgaris. The study was designed to compare the clinical efficacy and safety of topical adapalene gel 0.1% and tretinoin cream 0.025% in the treatment of acne vulgaris.

Methods A total of 80 patients with grade I-III acne vulgaris seen in the out-patient department of a tertiary care center were randomized to 8 weeks of daily treatment with either adapalene gel 0.1% or tretinoin gel 0.025%. Counts of total lesions, inflammatory lesions and non-inflammatory lesions were made at baseline and again at treatment weeks 2, 4, 6 and 8. Global assessment ratings, based on percent lesion reduction from baseline were also made. Side-effects like erythema, burning, pruritus, scaling and dryness were rated on a 0-3 severity scale.

Results Out of 80 patients there were 8 dropouts in the study; the 72 patients who completed the study were evaluated for efficacy and safety. Both adapalene and tretinoin produce dramatic reductions in total, inflammatory and non-inflammatory lesion counts, on an average. Cutaneous side-effects were limited to a mild retinoid dermatitis occurring in both treatment groups however patients treated with adapalene gel tolerated this therapy significantly better than those treated with tretinoin cream.

Conclusions Adapalene gel 0.1% offers comparable efficacy to tretinoin cream 0.025 % cream, but is less irritating. Adapalene gel 0.1% is a safe and effective topical agent in the treatment of mild to moderate acne vulgaris in Indian patients.