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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Centre Hospitalier Universitaire de Nice

Current Primary Outcome: decrease of number of cutaneous bullosa [ Time Frame: after 4 months of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nice

Dates:
Date Received: August 3, 2009
Date Started: October 2010
Date Completion:
Last Updated: May 6, 2014
Last Verified: May 2014