Actively Recruiting
A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-02-24
20
Participants Needed
4
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 6 years or older
- Laboratory confirmed diagnosis of Epidermolysis Bullosa Simplex severe due to KRT5 or KRT14 mutation (autosomal)
- Mean daily number of new blisters greater than 3
- Subject or caregiver agrees not to use any topical therapies other than those approved by the investigator
You will not qualify if you...
- Epidermolysis Bullosa Simplex 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
- Use of any systemic product that might put the subject at undue risk or interfere with study assessments within 30 days prior to Visit 1, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
CHU de Nice
Nice, France, France, 06000
Actively Recruiting
2
APHP Necker-Enfants-Malades
Paris, France, France, 75015
Not Yet Recruiting
3
APHP Hôpital Saint-Louis
Paris, France, France, 75018
Not Yet Recruiting
4
chu de Toulouse
Toulouse, France, 31059
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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