Topical Solution for the Treatment of Atopic Dermatitis

Summary

The study is designed as a proof of concept, multi-center, randomized, double-blind and vehicle-controlled study with intra-individual comparison of treatments. Three age cohorts of patients will be included in the study according to the following age ranges: 1. ≥18 years old (minimum 6, maximum 18 patients) 2. \>12 - 17 years old (minimum 6, maximum 18 patients) 3. \>2 - 12 years old (minimum 6, maximum 18 patients) The main objectives of study are: To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A \[CsA\]) compared to placebo topical solution for the treatment of patients with mild to moderate atopic dermatitis (AD). To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients with mild to moderate AD.

Timeline

Start

2016-09

Primary completion

2017-04-12

Completion

2017-04-12

Drugs

Indications