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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00951964
First received: August 3, 2009
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Epidermolysis Bullosa Dystrophica
Drug: Polyphenon E before Placebo
Drug: placebo before treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • decrease of number of cutaneous bullosa [ Time Frame: after 4 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • efficacity of treatment [ Time Frame: at 4 , 6, 7 10 months after beginnig of treatment and at year 1 ] [ Designated as safety issue: No ]
  • tolerance tio treatment [ Time Frame: at 1, 4, 6, 7, 10 and 12 months after beginnig the treatment ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: October 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • known mutation of COL7A1

Exclusion Criteria:

  • tea drinkers
  • patient receiving induction treatment,protease inhibitor treatment
  • liver failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951964

Locations
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, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Christine Chiaverini, PhD dermatology department, Nice University Hospital
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00951964     History of Changes
Other Study ID Numbers: 09-APN-01
Study First Received: August 3, 2009
Last Updated: May 6, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Additional relevant MeSH terms:
Epidermolysis Bullosa
Epidermolysis Bullosa Dystrophica
Collagen Diseases
Congenital Abnormalities
Connective Tissue Diseases
Genetic Diseases, Inborn
Skin Abnormalities
Skin Diseases
Skin Diseases, Genetic
Skin Diseases, Vesiculobullous
Epigallocatechin gallate
Anticarcinogenic Agents
Antimutagenic Agents
Antineoplastic Agents
Antioxidants
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014