Abstract:

Objective To evaluate the safety and efficacy of 1% pimecrolimus cream in the treatment of Chinese pediatric and adult patients with mild to moderate atopic dermatitis(AD). Methods This multicenter, randomized, double-blind, parallel group, vehicle-controlled trial was conducted at 7 research sites in China. Children and adults with mild to moderate atopic dermatitis were randomly assigned to treatment with 1% pimecrolimus cream or vehicle twice daily for 4 weeks. Efficacy evaluations were performed at baseline and at weeks 1, 2, and 4. The primary efficacy parameter was the Investigator's Global Assessment(IGA)score. Secondary parameters included Eczema Area and Severity Index(EASI)and severity of pruritus scores. Subjects were also asked to assess their disease control as uncontrolled, limited, good or complete. Results A total of 336 patients were included in the intent-to-treat analysis. At the end of study, 31.55%(53 of 168)of the patients were treated successfully with pimecrolimus cream based on IGA scores, a significant improvement compared with patients treated with vehicle [18.45%(31 of 168)] (P=0.0046).Furthermore, pimecrolimus-treated patients experienced significantly greater improvement than vehicle-treated patients in all efficacy parameters at each postbaseline visit(P<0.05).There was no significant difference in the incidence of adverse events between the two groups, with 19.64%(33/168)in the pimecrolimus-treated group and 24.40%(41/168)in the vehicle-treated group(P=0.3568).The most common adverse events were mild-to-moderate local application site reactions, such as erythema, pain, pruritus, burning, and folliculitis. Conclusion Pimecrolimus cream 1% is a safe and effective treatment alternative for Chinese uediatric and adult patients with mild to moderate AD.

Key words: Dermatitis, atopic, Pimecrolimus, Randomized controlled trials