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

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00014729
First received: April 10, 2001
Last updated: March 24, 2015
Last verified: May 2001
  Purpose

OBJECTIVES:

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


Condition Intervention Phase
Epidermolysis Bullosa
Drug: isotretinoin
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


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

Estimated Enrollment: 20
Study Start Date: October 2000
Estimated Study Completion Date: September 2002
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
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: March 24, 2015
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 Dystrophica
Epidermolysis Bullosa
Collagen Diseases
Congenital Abnormalities
Connective Tissue Diseases
Genetic Diseases, Inborn
Skin Abnormalities
Skin Diseases
Skin Diseases, Genetic
Skin Diseases, Vesiculobullous
Isotretinoin
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 05, 2015