Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)
Dystrophic epidermolysis bullosa hereditaria are genodermatosis responsible for formation of cutaneous bullous lesion arising spontaneously or after mechanical trauma.
These lesions are due to mutation on gene COL7A1 coding for collagen VII. There is no treatment available. Cares are consisting to dress lesions and to protect the skin.
The investigators have recently observed on patients having residual expression of collagen VII that phenotype severity is modulated by activation degree of dermic metalloproteinase. The investigators have also observed that epigallocatechin-3-gallate (Polyphenon E®) could be regulated this activity.
The primary purpose of this study is to assessing the efficacity of Polyphenon E to decrease the number of cutaneous bullosa after four month of treatment.
The primary outcome measure is the rate of patient presenting a decrease of 20% or more of the number of cutaneous bullosa.
Secondary outcomes are: severity of mucosa impairment, affected cutaneous surface, the average duration of cicatrisation and treatment tolerance.
This study foresees the inclusion of 22 patients older than 2 years old in 5 centers.
When patients are included, they will be randomized and receive the treatment (or placebo) for 4 months.
|Epidermolysis Bullosa Dystrophica||Drug: Polyphenon E before Placebo Drug: placebo before treatment||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)|
- decrease of number of cutaneous bullosa [ Time Frame: after 4 months of treatment ]
- efficacity of treatment [ Time Frame: at 4 , 6, 7 10 months after beginnig of treatment and at year 1 ]
- tolerance tio treatment [ Time Frame: at 1, 4, 6, 7, 10 and 12 months after beginnig the treatment ]
|Study Start Date:||October 2010|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
patients receive the treatment in first and placebo in second part of study
Drug: Polyphenon E before Placebo
patients receive polyphenon E during 4 months, then 2 months of wash-out and finally 4 months of placebo
patients receive placebo in first and treatment in second part of study
Drug: placebo before treatment
patients receive 4 months of placebo, then 2 months of wash out et finally 4 months of treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951964
|Dermatology Department, Bordeaux University Hospital|
|Dijon University Hospital, Dermatology Department|
|Dermatology Department, Necker Enfants Malades, APHP|
|Dermatology Department, Saint Louis Hospital, APHP|
|Toulouse University Hospital, Dermatology Department|
|Principal Investigator:||Christine Chiaverini, PhD||dermatology department, Nice University Hospital|