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

Epidermolysis Bullosa Dystrophica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951964
• Other study ID #: 09-APN-01
• Status: Completed
• Phase: Phase 2
• First received: August 3, 2009
• Last updated: May 6, 2014
• Start date: October 2010
• Est. completion date: July 2013

Study information

• Verified date: May 2014
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• known mutation of COL7A1

Exclusion Criteria:

• tea drinkers

• patient receiving induction treatment,protease inhibitor treatment

• liver failure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epidermolysis Bullosa
• Epidermolysis Bullosa Dystrophica

Intervention

Drug:
• Polyphenon E before Placebo
patients receive polyphenon E during 4 months, then 2 months of wash-out and finally 4 months of placebo
• placebo before treatment
patients receive 4 months of placebo, then 2 months of wash out et finally 4 months of treatment

Locations

Country	Name	City	State
France	Dermatology Department, Bordeaux University Hospital	Bordeaux
France	Dijon University Hospital, Dermatology Department	Dijon
France	Dermatology Department, Necker Enfants Malades, APHP	Paris
France	Dermatology Department, Saint Louis Hospital, APHP	Paris
France	Toulouse University Hospital, Dermatology Department	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease of number of cutaneous bullosa		after 4 months of treatment	No
Secondary	efficacity of treatment		at 4 , 6, 7 10 months after beginnig of treatment and at year 1	No
Secondary	tolerance tio treatment		at 1, 4, 6, 7, 10 and 12 months after beginnig the treatment	No