A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized
- Sponsor
- Centre Hospitalier Universitaire de Nice
- Study ID
- NCT06509984
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Epidermolysis Bullosa Simplex
- Genodermatosis
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Apremilast treatment — DRUGtreatment of apremilast
Study Details
The goal of this clinical trial is to Assessing the Efficacy and Safety of Apremilast in Patients \> 6 years of age with EB simplex generalized . The main question it aims to answer are: describe efficacity of this treatment. Participants will take treatments and have to use bullets during the study period.
Key Dates
- First listed
- Jul 19, 2024
- Start date
- Aug 6, 2024
- Status verified
- Feb 2025
- Primary completion
- Oct 1, 2025
- Completion
- Apr 1, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: apremilast treatmenttreatment by apremilast in two phases of challenge
Primary Outcome Measure
To describe efficacy of apremilast [ Time Frame: weeks 20 ]
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