Evidence map›Paper›PMID 27015660›Full record

Trial reportOrphanet journal of rare diseases2016

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

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

Registry-linked trialOpen access · goldAbstract readLetterRandomized Controlled Trial
In one paragraph

Trial report in Orphanet journal of rare diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00951964 (Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00951964 phase2completednot on this map

Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)

TypeinterventionalSponsorCentre Hospitalier Universitaire de NiceRan2010 to 2013Enrolled18ConditionsEpidermolysis Bullosa DystrophicaArmsPolyphenon E before Placebo, placebo before treatment
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Green Tea Catechins and Skin Health.Antioxidants (Basel, Switzerland) · 2024
    Review
  6. Review
  7. ABCB5Cytotherapy · 2023
    Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

Christine ChiaveriniReference Centre for Inherited Epidermolysis Bullosa, Archet 2 Hospital, Nice, France. chiaverini.c@chu-nice.fr.
Coralie RogerDepartment of Clinical Research and Innovation, University Hospital of Nice, Nice, France.
Eric FontasDepartment of Clinical Research and Innovation, University Hospital of Nice, Nice, France.
Emmanuelle BourratReference Centre of Rare Skin Diseases, MAGEC 5, Saint Louis Hospital, APHP, Paris, France.
Eva Bourdon-LanoyReference Centre of Rare Skin Diseases, MAGEC, Necker Hospital, APHP, Institut Imagine, Paris, France.
Christine LabrèzeReference Centre of Rare Skin Diseases, Pellegrin Hospital, Bordeaux, France.
Juliette MazereeuwReference Centre of Rare Skin Diseases, Larrey Hospital, Toulouse, France.
Pierre VabresDepartment of Dermatology, Bocage Hospital, Dijon, France.
Christine BodemerReference Centre of Rare Skin Diseases, MAGEC, Necker Hospital, APHP, Institut Imagine, Paris, France.
Jean-Philippe LacourReference Centre for Inherited Epidermolysis Bullosa, Archet 2 Hospital, Nice, France.
Assistance Publique – Hôpitaux de Paris · FRCentre National de la Recherche Scientifique · FRDélégation Paris 5 · FRHôpital Larrey · FRHôpital Pellegrin · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledRecessive 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 ).

Indexed as

CatechinCross-Over StudiesDouble-Blind MethodEpidermolysis Bullosa DystrophicaHumansMetalloendopeptidasesPhenolsUnited StatesCatechinepigallocatechin gallateMetalloendopeptidasesPhenolsCathechinDystrophic epidermolysis bullosaGreen teaMetalloproteinasePolyphenon

Identifiers

PMID27015660
PMCPMC4807580
OpenAlexW2310642031

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.