Traitement des épidermolyses bulleuses dystrophiques héréditaires par l’épigallocatéchine-3-gallate oral (Polyphenon E®)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-012750-21-FR
• Date of registration: 27/11/2009
• Prospective Registration: Yes
• Primary sponsor: CHU de NICE
• Public title: Traitement des épidermolyses bulleuses dystrophiques héréditaires par l’épigallocatéchine-3-gallate oral (Polyphenon E®)
• Scientific title: Traitement des épidermolyses bulleuses dystrophiques héréditaires par l’épigallocatéchine-3-gallate oral (Polyphenon E®)
• Date of first enrolment: 20/01/2010
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012750-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion criteria:
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Dystrophic epidermolysis bullosa hereditaria
MedDRA version: 12.0 Level: LLT Classification code 10056508 Term: Acquired epidermolysis bullosa

Intervention(s)

Trade Name: POLYPHENON E
Product Name: POLYPHENON E
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective:

Primary end point(s): The primary outcome measure is the rate of patient presenting a decrease of 20% or more of the number of cutaneous bullosa.

Main Objective: 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.

Secondary ID(s)

09-APN-01