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Short Term Observational Study in DEB Patients | Clinical Trials | Clareo Health

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Short Term Observational Study in DEB Patients

A Prospective Short-term Study to Evaluate Methodologies for the Assessment of Disease Extent, Impact, and Wound Evolution in Patients With Dystrophic Epidermolysis Bullosa (DEB)

NCT02178969•Shire

View on ClinicalTrials.gov

Summary

The purpose of this study is to better understand disease extent and to identify appropriate methodologies to evaluate (dystrophic epidermolysis bullosa) DEB in a quantitative and qualitative manner.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent is provided. Patients 18 years of age and older, and parent(s)/legal guardian(s) of patients younger than 18 years of age, must provide written informed consent prior to participating in the study; additionally, informed assent will be obtained from patients younger than 18 years of age as specified by local requirements.
•2. Patient must have a documented diagnosis of DEB based on genetic analysis showing a mutation in COL7A1 or, in the opinion of the investigator, a confirmed diagnosis of DEB based on histologic criteria (antigen mapping or electron microscopy).
•3. Patient must have at least 5 wounds that are suitable for imaging, in the opinion of the investigator, at the time of enrollment.
•4. Patient is willing and able to undergo the protocol-specified procedures.

Exclusion Criteria

•1. Patient has used or is currently using experimental treatment for DEB including, but not limited to, bone marrow transplantation, systemic immune suppression, or experimental procedures that involve live cells, with potential for systemic spread such as gene transfer, stem cell infusions, or other cell type injections such that, in the opinion of the investigator, inclusion poses an unacceptable risk to the patient or interpretation of these study data.
•2. Patient has squamous cell carcinoma with evidence of locally invasive disease or distant metastases.
•3. Patient is pregnant.

Locations (10)

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

Columbia University Medical Center

New York, New York, United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

Premier Specialists Pty Ltd

Kogarah, Australia

Salzburger Landeskliniken

Salzburg, Austria

Fakultni nemocnice Brno

Brno, Czechia

Service de Génétique et INSERM UMR 1163, Laboratoire de Génétique des maladies cutanées - Institut Imagine

Paris, France

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Istituto Dermopatico Dell'immacolata IRCCS

Rome, Italy

Key Dates

Start Date

June 24, 2014

Primary Completion Date

February 23, 2015

Completion Date

February 23, 2015

Last Updated

March 17, 2021

Enrollment

ACTUAL participants

Conditions

Dystrophic Epidermolysis Bullosa

Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa

NCT05157958

Dystrophic Epidermolysis Bullosa

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ACTIVE_NOT_RECRUITINGPHASE3

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

NCT04213261

Recessive Dystrophic Epidermolysis Bullosa

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ACTIVE_NOT_RECRUITINGPHASE3

Evaluation of D-Fi for the Treatment of Wounds Due to DEB

NCT06892639

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Short Term Observational Study in DEB Patients

Inclusion Criteria

Exclusion Criteria

Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

Evaluation of D-Fi for the Treatment of Wounds Due to DEB

Pilot Study of ELK-003 Eye Drops for Treating Ocular Manifestations of Epidermolysis Bullosa

A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients

Targeting Collagen VII Antibodies in Bullous Diseases Using Efgartigimod IV (VYVGART)