A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized

Overview

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

Conditions

Interventions

Eligibility

Locations (4)

Outcomes