A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-99
SponsorCentre Hospitalier Universitaire de Nice
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
- EBS lesions requiring oral therapy to treat an infection
Use of any diacerein containing product within 6 months prior to Visit 1
Use of systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to Visit 1
Use of systemic steroidal therapy within 30 days prior to Visit 1
Trial design
Treatments tested in this trial
- Apremilast treatment
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov