Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)

May 6, 2014 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Dermatology Department, Bordeaux University Hospital
      • Dijon, France
        • Dijon University Hospital, Dermatology Department
      • Paris, France
        • Dermatology Department, Necker Enfants Malades, APHP
      • Paris, France
        • Dermatology Department, Saint Louis Hospital, APHP
      • Toulouse, France
        • Toulouse University Hospital, Dermatology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • known mutation of COL7A1

Exclusion Criteria:

  • tea drinkers
  • patient receiving induction treatment,protease inhibitor treatment
  • liver failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
decrease of number of cutaneous bullosa
Time Frame: after 4 months of treatment
after 4 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
efficacity of treatment
Time Frame: at 4 , 6, 7 10 months after beginnig of treatment and at year 1
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
at 1, 4, 6, 7, 10 and 12 months after beginnig the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Christine Chiaverini, PhD, dermatology department, Nice University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

August 3, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (Estimate)

August 4, 2009

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-APN-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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