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Orphanet J Rare Dis. 2016 Mar 25;11:31. doi: 10.1186/s13023-016-0411-5.

Oral epigallocatechin-3-gallate for treatment of dystrophic epidermolysis bullosa: a multicentre, randomized, crossover, double-blind, placebo-controlled clinical trial.

Author information

1
Reference Centre for Inherited Epidermolysis Bullosa, Archet 2 Hospital, Nice, France. chiaverini.c@chu-nice.fr.
2
INSERM, U1081, CNRS, UMR7284, Institute for Research on Cancer and Aging of Nice, University of Nice Sophia Antipolis, Nice, France. chiaverini.c@chu-nice.fr.
3
Department of Clinical Research and Innovation, University Hospital of Nice, Nice, France.
4
Reference Centre of Rare Skin Diseases, MAGEC 5, Saint Louis Hospital, APHP, Paris, France.
5
Reference Centre of Rare Skin Diseases, MAGEC, Necker Hospital, APHP, Institut Imagine, Paris, France.
6
Reference Centre of Rare Skin Diseases, Pellegrin Hospital, Bordeaux, France.
7
Reference Centre of Rare Skin Diseases, Larrey Hospital, Toulouse, France.
8
Department of Dermatology, Bocage Hospital, Dijon, France.
9
Université Paris Descartes - Sorbonne Paris Cité, Paris, France.
10
Reference Centre for Inherited Epidermolysis Bullosa, Archet 2 Hospital, Nice, France.
11
INSERM, U1081, CNRS, UMR7284, Institute for Research on Cancer and Aging of Nice, University of Nice Sophia Antipolis, Nice, France.

Abstract

Recessive dystrophic epidermolysis bullosa (RDEB) is a rare genodermatosis with severe blistering. No curative treatment is available. Scientific data indicated that epigallocatechin-3-gallate (EGCG), a green tea extract, might improve the phenotype of RDEB patients. In a multicentre, randomized, crossover, double-blind, placebo-controlled clinical trial, we evaluated a 4-month oral EGCG treatment regimen in 17 RDEB patients. We found that EGCG treatment was not more effective than placebo in modified intention to treat and per protocol analysis (n = 16; p = 0.78 and n = 10; p = 1 respectively). Tolerance was good. Specific organizational and technical difficulties of controlled randomized double-blind trials in EB patients are discussed.

TRIAL REGISTRATION:

US National Institutes of Health Clinical Trial Register ( NCT00951964 ).

KEYWORDS:

Cathechin; Dystrophic epidermolysis bullosa; Green tea; Metalloproteinase; Polyphenon

PMID:
27015660
PMCID:
PMC4807580
DOI:
10.1186/s13023-016-0411-5
[Indexed for MEDLINE]
Free PMC Article

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