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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2001 by FDA Office of Orphan Products Development. Recruitment status was Active, not recruiting

First Received on April 10, 2001. Last Updated on June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	University of North Carolina
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00014729

Purpose

OBJECTIVES:

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

Condition	Intervention	Phase
Epidermolysis Bullosa	Drug: isotretinoin	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: dystrophic epidermolysis bullosa epidermolysis bullosa simplex epidermolysis bullosa with pyloric atresia junctional epidermolysis bullosa

Drug Information available for: Isotretinoin

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	20
Study Start Date:	October 2000

Detailed Description:

PROTOCOL OUTLINE:

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

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014729

Sponsors and Collaborators

FDA Office of Orphan Products Development

University of North Carolina

Investigators

Study Chair:

Jo-David Fine

University of North Carolina

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00014729 History of Changes
Other Study ID Numbers:	199/15738, UNCCH-FDR001796
Study First Received:	April 10, 2001
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

dermatologic disorders
epidermolysis bullosa
genetic diseases and dysmorphic syndromes
rare disease

Additional relevant MeSH terms:

Epidermolysis Bullosa
Epidermolysis Bullosa Dystrophica
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases

Skin Diseases, Vesiculobullous
Collagen Diseases
Connective Tissue Diseases
Isotretinoin
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012