Topical Solution for the Treatment of Atopic Dermatitis
Status:
Completed
Trial end date:
2017-04-12
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Spherium Biomed
Collaborators:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Germans Trias i Pujol Hospital Hospital del Mar Hospital General Universitario de Alicante Hospital Infantil Universitario Niño Jesús, Madrid, Spain Hospital Sant Joan de Deu Hospital Universitario La Fe Hospital Universitario Virgen de la Victoria Hospital Universitario Virgen Macarena