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

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

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.

Publication types

  • Letter
  • Randomized Controlled Trial

MeSH terms

  • Catechin / analogs & derivatives*
  • Catechin / therapeutic use
  • Cross-Over Studies
  • Double-Blind Method
  • Epidermolysis Bullosa Dystrophica / drug therapy*
  • Epidermolysis Bullosa Dystrophica / enzymology
  • Humans
  • Metalloendopeptidases / metabolism
  • Phenols / therapeutic use
  • United States

Substances

  • Phenols
  • Catechin
  • epigallocatechin gallate
  • Metalloendopeptidases

Associated data

  • ClinicalTrials.gov/NCT00951964