A Phase 2 interventional study of Apremilast treatment in Epidermolysis Bullosa Simplex and Genodermatosis, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 4 sites in France. Open to participants aged 6 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 2, Interventional, and Treatment
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.
The patient will have 7 visits. After Confirmation of inclusion criteria and no exclusion criteria, the study will be explain to the patient after signing the inform consent and be included in the study Treatment Period (Period 1); challenge period This period will be the first treatment period that will occur from 8 weeks. During this period the patient will see the doctor at the hospital, he will perform the study procedures The second period : dechallenge (period 2): All patients stop their treatment for 4 weeks.
The second treatment period - rechallenge (period 3) the patient will take the treatment for a second 8 weeks period At week 20 - End of study
At each visit:
The investigator at each visit compliance to the treatment and adverse events, Measure vital signs and perform clinical examination.
The patient will assess the different questionnaires, for the study
20 studies on the registry are indexed under Epidermolysis Bullosa Simplex; 5 are open to participants now.
This study's planned enrollment of 20 is close to the median of 19 across 17 interventional studies indexed under Epidermolysis Bullosa Simplex.
Browse Epidermolysis Bullosa Simplex studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
treatment by apremilast in two phases of challenge
Drug: Apremilast treatment
treatment of apremilast
To describe efficacy of apremilast
number of new blister conting every day
Time frame: weeks 20
Safety of apremilast treatment
number of SAE
Time frame: weeks 20
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Epidermolysis Bullosa Simplex →
Centre Hospitalier Universitaire de Nice →