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


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

SUBMITTER: Chiaverini C 

PROVIDER: S-EPMC4807580 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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

Chiaverini Christine C   Roger Coralie C   Fontas Eric E   Bourrat Emmanuelle E   Bourdon-Lanoy Eva E   Labrèze Christine C   Mazereeuw Juliette J   Vabres Pierre P   Bodemer Christine C   Lacour Jean-Philippe JP  

Orphanet journal of rare diseases 20160325


<h4>Unlabelled</h4>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  ...[more]

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