Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epidermolysis Bullosa Dystrophica |
Drug: Polyphenon E before Placebo Drug: placebo before treatment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
- efficacity of treatment [ Time Frame: at 4 , 6, 7 10 months after beginnig of treatment and at year 1 ] [ Designated as safety issue: No ]
- tolerance tio treatment [ Time Frame: at 1, 4, 6, 7, 10 and 12 months after beginnig the treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 22 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
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
|
|
2
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
|
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- known mutation of COL7A1
Exclusion Criteria:
- tea drinkers
- patient receiving induction treatment,protease inhibitor treatment
- liver failure
Contacts and Locations| Contact: Christine CHIAVERINI, PhD | chiaverini.c@chu-nice.fr |
| France | |
| Dermatology Department, Bordeaux University Hospital | Recruiting |
| Bordeaux, France | |
| Contact: Alain TAIEB, PhD alain.taieb@chu-bordeaux.fr | |
| Principal Investigator: Alain TAIEB, PhD | |
| Sub-Investigator: Christine LABREZE, PhD | |
| Dijon University Hospital, Dermatology Department | Recruiting |
| Dijon, France | |
| Contact: Pierre VABRES, PhD | |
| Principal Investigator: Pierre VABRES, PhD | |
| Dermatology Department, Necker Enfants Malades, APHP | Not yet recruiting |
| Paris, France | |
| Contact: Christine BODEMER, PhD christine.bodemer@nck.ap-hop-paris.fr | |
| Principal Investigator: Christine BODEMER, PhD | |
| Sub-Investigator: Eva BOURDON LANOY, PhD | |
| Dermatology Department, Saint Louis Hospital, APHP | Recruiting |
| Paris, France | |
| Contact: Emmanuelle BOURRAT, PhD emmanuelle.bourrat@sls.aphp.fr | |
| Principal Investigator: Emmanuelle BOURRAT, PhD | |
| Toulouse University Hospital, Dermatology Department | Recruiting |
| Toulouse, France | |
| Contact: Juliette MAZEREEUW, PhD mazereeuw-hautier.j@chu-toulouse.fr | |
| Principal Investigator: Juliette MAZEREEUW, PhD | |
| Principal Investigator: | Christine Chiaverini, PhD | dermatology department, Nice University Hospital |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT00951964 History of Changes |
| Other Study ID Numbers: | 09-APN-01 |
| Study First Received: | August 3, 2009 |
| Last Updated: | December 8, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee |
Additional relevant MeSH terms:
|
Epidermolysis Bullosa Epidermolysis Bullosa Dystrophica Skin Abnormalities Congenital Abnormalities Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases Skin Diseases, Vesiculobullous Collagen Diseases Connective Tissue Diseases Epigallocatechin gallate |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antimutagenic Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses Neuroprotective Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013