Atopic Dermatitis Clinical Trial
Official title:
Evaluation of SP14019-F-01 Topical Solution for the Treatment of Atopic Dermatitis. Pilot Study (CYCLATOP STUDY)
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
;
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