Safety and Efficacy of Tacrolimus 0.03% Ointment in the Treatment of Atopic Dermatitis: A Randomized, Double-Blind, Placebo Controlled Clinical Trial

Background and Aim: Atopic dermatitis (AD) is a chronic, relapsing, pruritic skin disease more common in infancy and childhood. Emollients, topical corticosteroids, and avoidance of irritating factors are the mainstay of its treatment, but fear of side effects has limited the use of topical corticosteroids. The objective of this study was to evaluate the safety and efficacy of topical tacrolimus 0.03% ointment in the treatment of AD. Methods: In this randomized, double-blind, clinical trial, 76 patients with AD older than 2 years were randomly allocated in two groups and treated with either tacrolimus 0.03% ointment (Abu-Rayhan Co., Iran) or placebo, twice a day for 6 weeks. Responses to treatment were compared every 2 weeks using SCORAD. Results: Twenty-nine patients in tacrolimus group and 26 in placebo group completed the trial. The reduction in SCORAD after 2 and 4 weeks in tacrolimus group was significantly higher than placebo group (P<0/05). The frequency of treatment-induced pruritus and burning sensation was similar in both groups but erythema was more observed in the placebo group (P<0/05). Conclusion: Tacrolimus 0.03% ointment is more effective than placebo in the treatment of AD. ackground and Aim: Anti-inflammatory and hypo- pigmenting effects of topical tretinoin and alpha-hydroxy acids have been documented. This study was designed to compare the efficacy of 0.05% tretinion cream with 7% alpha-hydroxy acid in the treatment of ephelides. Methods: In this clinical trial 80 patients with ephelides were selected and allocated into two groups. One group was treated with 0.05% tretinoin cream every other night. The other group was treated with 7% alpha-hydroxy acid cream in the same manner. Both groups were treated with antisolar creams and followed every month for 5 months. Results: After 5 months excellent therapeutic response was achieved in 3 (7.5%) of patients who were treated with 0.05% tretinoin cream compared to 8 (20%) in alpha-hydroxy acid cream. Good therapeutic response was observed in 20 (50%) of tretinoin group versus 16 (40%) in alpha-hydroxy acid group. Patient's satisfaction from treatment was consistent with evaluation by dermatologists (P=0.384 and P=0.132). Conclusion: Both 0.05% tretinoin cream and 7% alpha-hydroxy acid cream are equally efficient in the treatment of ephelides.