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

Tracking Information

First Received Date ^ICMJE

April 10, 2001

Last Updated Date

June 23, 2005

Start Date ^ICMJE

October 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00014729 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

OBJECTIVES:

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

Detailed Description

PROTOCOL OUTLINE:

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Epidermolysis Bullosa

Intervention ^ICMJE

Drug: isotretinoin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00014729

Responsible Party

Study ID Numbers ^ICMJE

199/15738, UNCCH-FDR001796

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

University of North Carolina

Investigators ^ICMJE

Study Chair:

Jo-David Fine

University of North Carolina

Information Provided By

FDA Office of Orphan Products Development

Verification Date

May 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP