title: 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.
  
  
  BACKGROUND
  US National Institutes of Health Clinical Trial Register ( NCT00951964 ).
authors.affiliation: Reference Centre for Inherited Epidermolysis Bullosa, Archet 2 Hospital, Nice, France. chiaverini.c@chu-nice.fr.|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.
authors.forename: Christine
authors.initials: C
authors.lastname: Chiaverini
authors.affiliation: Department of Clinical Research and Innovation, University Hospital of Nice, Nice, France.
authors.forename: Coralie
authors.initials: C
authors.lastname: Roger
authors.affiliation: Department of Clinical Research and Innovation, University Hospital of Nice, Nice, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Fontas
authors.affiliation: Reference Centre of Rare Skin Diseases, MAGEC 5, Saint Louis Hospital, APHP, Paris, France.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Bourrat
authors.affiliation: Reference Centre of Rare Skin Diseases, MAGEC, Necker Hospital, APHP, Institut Imagine, Paris, France.
authors.forename: Eva
authors.initials: E
authors.lastname: Bourdon-Lanoy
authors.affiliation: Reference Centre of Rare Skin Diseases, Pellegrin Hospital, Bordeaux, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Labrèze
authors.affiliation: Reference Centre of Rare Skin Diseases, Larrey Hospital, Toulouse, France.
authors.forename: Juliette
authors.initials: J
authors.lastname: Mazereeuw
authors.affiliation: Department of Dermatology, Bocage Hospital, Dijon, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Vabres
authors.affiliation: Reference Centre of Rare Skin Diseases, MAGEC, Necker Hospital, APHP, Institut Imagine, Paris, France.|Université Paris Descartes - Sorbonne Paris Cité, Paris, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Bodemer
authors.affiliation: Reference Centre for Inherited Epidermolysis Bullosa, Archet 2 Hospital, Nice, France.|INSERM, U1081, CNRS, UMR7284, Institute for Research on Cancer and Aging of Nice, University of Nice Sophia Antipolis, Nice, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Lacour
mesh_terms: D002392:Catechin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018592:Cross-Over Studies; D004311:Double-Blind Method; D016108:Epidermolysis Bullosa Dystrophica / Q000188:drug therapy* / Q000201:enzymology; D006801:Humans; D008666:Metalloendopeptidases / Q000378:metabolism; D010636:Phenols / Q000627:therapeutic use; D014481:United States
chemical_list: D010636:Phenols; D002392:Catechin; C045651:epigallocatechin gallate; D008666:Metalloendopeptidases
keywords: Cathechin; Dystrophic epidermolysis bullosa; Green tea; Metalloproteinase; Polyphenon