Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa

Epidermolysis Bullosa Dystrophica Clinical Trial

Official title:

Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01019148
• Other study ID #: SU-11182009-4402
• Status: Recruiting
• Start date: November 10, 2009
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: Irene Bailey-Healy
• Phone: (650) 721-7149
• Email: baileyhi[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of RDEB by local dermatologist

• 7 years of age or older

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Epidermolysis Bullosa
• Epidermolysis Bullosa Dystrophica

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa	Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa for future studies	4 years