Topical Solution for the Treatment of Atopic Dermatitis (CYCLATOP)

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.

• Absolute change from baseline (Day 0) of Eczema Area and Severity Index (EASI) score of the treated body area (CsA vs Vehicle control placebo)
• Change from baseline (Day 0) of Investigator's Global Assessment (IGA) score (on a 0 to 4-point scale; CsA vs Vehicle control placebo)
• Absolute change from baseline (Day 0) of Atopic Dermatitis Severity Index (ADSI) score (Cs vs Vehicle control placebo)

1. Last registry update

   Apr 17, 2018

2. Primary completion

   Apr 12, 2017

3. Started

   Sep 2016

4. Registered

   Aug 12, 2016