A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized
Recruiting
Phase 2
Interventional Study
Epidermolysis Bullosa Simplex
Genodermatosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 99
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Centre Hospitalier Universitaire de Nice · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male or female patients 6 years or older
* Laboratory confirmed diagnosis of EBS-sev due to KRT5 or 14 mutation (autosomal)
* Mean daily number of new blisters \>3.
* Subject/caregiver agrees not to use any topical therapies other than the investigator approved
Exclusion Crit…
Contacts
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