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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00014729
First Posted: April 11, 2001
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
FDA Office of Orphan Products Development
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014729


Sponsors and Collaborators
University of North Carolina
Investigators
Study Chair: Jo-David Fine University of North Carolina
  More Information

ClinicalTrials.gov Identifier: NCT00014729     History of Changes
Other Study ID Numbers: 199/15738
UNCCH-FDR001796
First Submitted: April 10, 2001
First Posted: April 11, 2001
Last Update Posted: March 25, 2015
Last Verified: May 2001

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
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
Collagen Diseases
Connective Tissue Diseases
Isotretinoin
Dermatologic Agents