Ignite Creation Date:
2024-05-05 @ 9:43 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00951964
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2009-08-03
Brief Title:
Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E Epigallocatechin 3 Gallate
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E Epigallocatechin 3 Gallate
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None