Title |
Oral epigallocatechin-3-gallate for treatment of dystrophic epidermolysis bullosa: a multicentre, randomized, crossover, double-blind, placebo-controlled clinical trial
|
---|---|
Published in |
Orphanet Journal of Rare Diseases, March 2016
|
DOI | 10.1186/s13023-016-0411-5 |
Pubmed ID | |
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. US National Institutes of Health Clinical Trial Register ( NCT00951964 ). |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 1 | 17% |
Spain | 1 | 17% |
United Kingdom | 1 | 17% |
Unknown | 3 | 50% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 4 | 67% |
Scientists | 1 | 17% |
Science communicators (journalists, bloggers, editors) | 1 | 17% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Chile | 1 | 2% |
Unknown | 41 | 98% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Bachelor | 9 | 21% |
Student > Master | 5 | 12% |
Other | 3 | 7% |
Professor | 3 | 7% |
Researcher | 3 | 7% |
Other | 7 | 17% |
Unknown | 12 | 29% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 10 | 24% |
Agricultural and Biological Sciences | 4 | 10% |
Chemistry | 4 | 10% |
Biochemistry, Genetics and Molecular Biology | 2 | 5% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 2% |
Other | 5 | 12% |
Unknown | 16 | 38% |