NCT00951964

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epidermolysis Bullosa Dystrophica

Interventions

Type	Name	Description
DRUG	Polyphenon E before Placebo	patients receive polyphenon E during 4 months, then 2 months of wash-out and finally 4 months of placebo
DRUG	placebo before treatment	patients receive 4 months of placebo, then 2 months of wash out et finally 4 months of treatment

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2009-08-04
• Last updated: 2014-05-07

Locations

5 sites across 1 country: France