ClinicalTrials.gg
RecruitingNCT01019148Updated Apr 24, 2026

Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa

An observational study in Epidermolysis Bullosa Dystrophica, sponsored by Stanford University. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Stanford University · Observational

From the registry’s dates

  • Started Nov 2009; still recruiting 17 years later.

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
70
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 45 studies in Epidermolysis Bullosa Dystrophica with a site in United States — 12 open to participants now, 16 under way, 4 of them phase 3. Epidermolysis Bullosa Dystrophica · United States.

Planned enrollment
3rd of 13
70 · median 29
Started
2009
with 2 others
Observational
13 of 45
6 open now
Primary completion
2029-12
later than 13 of 15 live
Registered
6th of 45
by date
Lead sponsor
5 of 45
Stanford University

Among the 45 studies in Epidermolysis Bullosa Dystrophica with a site in United States, this one is the 3rd largest by planned enrollment of the 13 observational ones that give a count, is one of 3 that started in 2009, is one of 13 observational ones, reaches primary completion later than 13 of the 15 other live ones, and was the 6th registered.

Epidermolysis Bullosa Dystrophica

78 studies on the registry are indexed under Epidermolysis Bullosa Dystrophica; 21 are open to participants now.

Browse Epidermolysis Bullosa Dystrophica studies →

Open to participants now

12 of the 45 studies in Epidermolysis Bullosa Dystrophica with a site in United States are open now. Recruiting first, the newest first:

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All 12 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 17 Epidermolysis Bullosa Dystrophica studies recruiting now, 13 (76%) set no upper age limit and 3 (18%) stop at 75 or younger; 15 take children under 18; 2 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study summary

Recessive dystrophic epidermolysis bullosa (RDEB) is a disease caused by genetic mutations in the gene for type VII collagen. Patients with RDEB develop large, severely painful blisters and open wounds from minor trauma to their skin. We are screening subjects with RDEB to evaluate characteristics of the subjects and their cells in order to develop new strategies of therapy and determine whether subjects could be candidates for treatment studies.

Read the detailed description

We will obtain a detailed medical history and will perform a skin examination and brief physical exam. Photographs may be taken. We will ask questions about the size and duration wounds.

LAB TESTS We will draw blood to determine overall health status to include Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV) testing. Genetic testing may also be performed.

BIOPSIES Biopsies may be collected to check for Collagen 7 and for antibodies to Collagen 7.

Based on the results obtained, it may be possible to identify patients who would qualify to participate in current or future clinical trials.

03

Conditions studied

  • Epidermolysis Bullosa Dystrophica
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with RDEB by a local dermatologist who are medically stable enough to travel to Stanford University Medical Center. Patients should also be at least 7 years of age.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of RDEB by local dermatologist
  • 7 years of age or older

Exclusion criteria

Exclusion Criteria:

-Medical instability limiting ability to travel to Stanford University Medical Center

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
70 participants (estimated)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa

    Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa for future studies

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Stanford University School of Medicine
    Stanford, California 94305, United States
    Recruiting
    • Irene Bailey-Healy · Contactbaileyhi@stanford.edu · (650) 721-7149
    • Jean Tang, MD, PhD · Principal investigator
    • M. Peter Marinkovich, MD · Sub investigator
    • Anthony Oro, MD · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2009 (actual). Primary completion is estimated for Dec 2029, 241 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2009
First posted
Nov 25, 2009
StartActual
Nov 10, 2009
Primary completionEst.
Dec 31, 2029
CompletionEst.
Dec 31, 2029
Last update
Apr 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01019148
Responsible party
Jean Yuh Tang (Professor, Stanford University) — Principal investigator
First posted
Nov 25, 2009
Start date
Nov 10, 2009
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Apr 24, 2026

Study contacts

Irene Bailey-Healy
Contact
baileyhi@stanford.edu
(650) 721-7149
Jean Tang, MD, PhD
principal investigator · Stanford University
View the source record on ClinicalTrials.gov ↗

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