Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)
- Conditions
- Epidermolysis Bullosa Dystrophica
- Interventions
- Drug: Polyphenon E before PlaceboDrug: placebo before treatment
- Registration Number
- NCT00951964
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- known mutation of COL7A1
- tea drinkers
- patient receiving induction treatment,protease inhibitor treatment
- liver failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Polyphenon E before Placebo patients receive the treatment in first and placebo in second part of study 2 placebo before treatment patients receive placebo in first and treatment in second part of study
- Primary Outcome Measures
Name Time Method decrease of number of cutaneous bullosa after 4 months of treatment
- Secondary Outcome Measures
Name Time Method efficacity of treatment at 4 , 6, 7 10 months after beginnig of treatment and at year 1 tolerance tio treatment at 1, 4, 6, 7, 10 and 12 months after beginnig the treatment
Trial Locations
- Locations (5)
Dermatology Department, Necker Enfants Malades, APHP
🇫🇷Paris, France
Dijon University Hospital, Dermatology Department
🇫🇷Dijon, France
Dermatology Department, Saint Louis Hospital, APHP
🇫🇷Paris, France
Toulouse University Hospital, Dermatology Department
🇫🇷Toulouse, France
Dermatology Department, Bordeaux University Hospital
🇫🇷Bordeaux, France