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.Trial registrationUS National Institutes of Health Clinical Trial Register (NCT00951964).Electronic supplementary materialThe online version of this article (doi:10.1186/s13023-016-0411-5) contains supplementary material, which is available to authorized users.

Chronic Polyphenon-60 or Catechin Treatments Increase Brain Monoamines Syntheses and Hippocampal SIRT1 LEVELS Improving Cognition in Aged Rats

“…Regarding therapeutic potential of green tea extracts, most works have focused on its main component, epigallocatechin gallate, which constitutes around 50%-65% of the total content. Catechin represents only around 1%-4% of most green tea extract, whereas total polyphenolic content of polyphenon-60 is around 80%-90% [48,[64][65][66]. Other works also show neuroprotective effects for catechin, in which oxidative stress counteraction has been postulated as the main underlying mechanism [30,67].…”

Diacerein orphan drug development for epidermolysis bullosa simplex: A phase 2/3 randomized, placebo-controlled, double-blind clinical trial

“…It is possibly for this reason that there is hardly any literature on randomized controlled trials in EB. [23][24][25][26][27][28] Still, there is a pressing need for treatments that address the underlying pathophysiology of this blistering disease and can reduce blister numbers with an acceptable side effect profile. Currently, however, progress has been made only in the field of ex vivo gene therapy for distinct subtypes of EB (junctional and dystrophic).…”

Small molecule drug development for rare genodermatoses – evaluation of the current status in epidermolysis bullosa

“…Therefore, the MMP7 inhibitor EGCG was used to treat 17 RDEB patients in an RCT-clinical trial with the aim to reduce blister numbers as well as itch, and to improve wound healing. Although a reduction in blister numbers was observed in 50% of patients compared to placebo, statistical analysis showed no significant difference [79]. Currently, no further trials are registered.…”