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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2016-12

AUTHORS

Christine Chiaverini, Coralie Roger, Eric Fontas, Emmanuelle Bourrat, Eva Bourdon-Lanoy, Christine Labrèze, Juliette Mazereeuw, Pierre Vabres, Christine Bodemer, Jean-Philippe Lacour

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 ). More... »

PAGES

31

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s13023-016-0411-5

DOI

http://dx.doi.org/10.1186/s13023-016-0411-5

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1006423013

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/27015660


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