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.
The study is designed as a proof of concept, multi-center, randomized, double-blind and vehicle-controlled study with intra-individual comparison of treatments. CsA plasma concentration assessments will be carried out at Visit 0 predose, and Visits 1 and 4 of the study period. 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 study will close when the total of 36 patients has been included among all age groups and the minimum number of 6 patients has been reached for each age group. Before including paediatric population, a minimum of 6 adult patients should complete the treatment to assess the safety profile. A randomized list will be created to determine in which side of the body (left or right) the subject will apply each medication (SP14019-F-01 topical solution \[5% CsA\] or SP14019-F-02 vehicle-control placebo solution). Solutions will be applied twice daily for four complete weeks (28 days) in all affected areas. Photography will be used to record the evolution of the lesions at Visits 0 (pre-1st dose), Visits 1, 2, 3, 4 and follow-up. 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. A Steering Committee will convene periodically to maintain the quality of study conduct, and to discuss any major issues or concerns and with particular attention to some critical events which may lead to stop the recruitment. These critical events are the observation of either new unexpected signals on safety related to CsA. The Steering Committee will also evaluate the safety profile of the treatment before including paediatric population
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
topical solution
topical vehicle solution
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Absolute change from baseline (Day 0) of Eczema Area and Severity Index (EASI) score of the treated body area (CsA vs Vehicle control placebo)
Time frame: Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).
Change from baseline (Day 0) of Investigator's Global Assessment (IGA) score (on a 0 to 4-point scale; CsA vs Vehicle control placebo)
Time frame: Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).
Absolute change from baseline (Day 0) of Atopic Dermatitis Severity Index (ADSI) score (Cs vs Vehicle control placebo)
Time frame: Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).
Frequency and severity of treatment-emergent adverse events (TEAEs).
Time frame: From date of randomization (Day 0) until 6 weeks
Frequency and severity of TEAEs leading to study drug discontinuation
Time frame: From date of randomization (Day 0) until 6 weeks
CsA plasma concentrations
samples obtained just before the first daily dose (around 8 am) on Visits 0, 1 and 4 to check the absence of systemic absorption during the period of treatment.
Time frame: From date of randomization (Day 0) up to 4 weeks, on day 7 and 28.
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