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NCT Number: NCT00951964

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.

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Key information

Conditions

Epidermolysis Bullosa Dystrophica Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Epidermolysis Bullosa Genetic Diseases, Inborn Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Department, Bordeaux University Hospital, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • known mutation of COL7A1

Exclusion criteria

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

Treatment and study plan

Polyphenon E before Placebo

Drug

patients receive polyphenon E during 4 months, then 2 months of wash-out and finally 4 months of placebo

placebo before treatment

Drug

patients receive 4 months of placebo, then 2 months of wash out et finally 4 months of treatment

Primary outcomes

  1. decrease of number of cutaneous bullosa

    Time frame: after 4 months of treatment

Secondary outcomes

  1. efficacity of treatment

    Time frame: at 4 , 6, 7 10 months after beginnig of treatment and at year 1

  2. tolerance tio treatment

    Time frame: at 1, 4, 6, 7, 10 and 12 months after beginnig the treatment

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 4, 2009
Registry last updated
May 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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