Epidermolysis Bullosa DystrophicaNCT01019148
Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa
An observational study of Epidermolysis Bullosa Dystrophica, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epidermolysis Bullosa Dystrophica
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2009to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of RDEB by local dermatologist
- 7 years of age or older
Who cannot join
- -Medical instability limiting ability to travel to Stanford University Medical Center
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University School of Medicine
Stanford, California, 94305
Irene Bailey-Healy, (650) 721-7149, baileyhi@stanford.edu
Jean Tang, MD, PhD
About this study
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.
- Conditions
- Epidermolysis Bullosa Dystrophica
- Medical subject headings
- Epidermolysis Bullosa Dystrophica
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa
Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa for future studies
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study start10 Nov 2009
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis Bullosa DystrophicaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Yuh Tang, Stanford University
- Investigators
- Jean Tang, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019148
- Sponsor's protocol ID
- SU-11182009-4402
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2009
- Last updated
- 24 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT01019148
- Acronym / sponsor ID
- SU-11182009-4402
- Conditions
- Epidermolysis Bullosa Dystrophica
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 10 Nov 2009 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Clinical diagnosis of RDEB by local dermatologist
- 7 years of age or older
Key exclusion criteria (1 listed)
- -Medical instability limiting ability to travel to Stanford University Medical Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa
Time frame: 10 years
Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa for future studies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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RDEB
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Tang, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidermolysis Bullosa Dystrophica, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irene Bailey-Healy ((650) 721-7149, baileyhi@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.