Topical Solution for the Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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
    

Intervention name(s): Cyclosporine 5% solution; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): topical solution; topical vehicle solution
Other intervention name(s): ciclosporin; SP14019-F-02 Placebo
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: atopic dermatitis; eczema; children; skin; topical; cyclosporine