Background and Aim: Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. Retinoids are used as the first line therapy in acne. Systemic absorption and skin irritation including redness, pruritus and exfoliation are some of their side effects. In this study we compared the efficacy of isotretinoin 0.05% niosomal gel versus adapalen 0.1% gel in treatment of acne vulgaris.

Methods: In this randomized double blind clinical trial, 144 patients with mild to moderate acne vulgaris aged from 15 to 30 years were enrolled. The patients were randomly allocated into two groups of A, whom were treated with isotretinoin 0.05% niosomal gel and B whom were treated with adapalen 0.1% gel. The patients were evaluated for clinical reponse, decrease in the number of inflammatory and non-inflammatory lesions and side effects after 2, 4, 8, and 12 weeks of the initiation of treatment.

Results: At the end of the study the clinical responses of comedones and inflammatory lesions in isotretinoin 0.05% niosomal gel group were 68% and 79%, in comparison with 65% and 76% in the adapalen gel group,  respectively. The differences were not statistically significant. At the end of the treatment period more decrease in number of inflammatory and non-inflammatory lesions were seen in group A patients (niosomal isotretinoin) than group B (adapalen 0.1% gel) (P<0.001). Also side effect of skin redness was found more in group B (P<0.001).

Conclusion: Isotretinoin 0.05% niosomal gel has less side effects and more efficacy in the treatment of mild to moderate acne vulgaris in comparison with adapalen 0.1% gel.