Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa

March 24, 2015 updated by: University of North Carolina

OBJECTIVES:

I. Determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis bullosa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PROTOCOL OUTLINE:

Patients receive oral isotretinoin daily for 8 months in the absence of disease progression or unacceptable toxicity.

Completion date provided represents the completion date of the grant per OOPD records

Study Type

Interventional

Enrollment

20

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) RDEB Hallopeau-Siemens OR RDEB non-Hallopeau-Siemens
  • Concurrent enrollment in the National Epidermolysis Bullosa Registry
  • No regional or distant metastasis in patients with previous or concurrent squamous cell carcinoma

--Patient Characteristics--

  • Hepatic: No clinically significant hypertriglyceridemia No clinically significant hepatic dysfunction
  • Renal: No clinically significant renal dysfunction
  • Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina

Investigators

  • Study Chair: Jo-David Fine, University of North Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Study Completion

September 1, 2002

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

April 10, 2001

First Posted (Estimate)

April 11, 2001

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

May 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/15738
  • UNCCH-FDR001796

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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