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Trial record 65 of 163 for:    ISOTRETINOIN

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

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. Identifier: NCT00014729
Recruitment Status : Completed
First Posted : April 11, 2001
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:


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

Condition or disease Intervention/treatment Phase
Epidermolysis Bullosa Drug: isotretinoin Phase 1

Detailed Description:


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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Primary Purpose: Treatment
Study Start Date : October 2000
Study Completion Date : September 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

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 identifier (NCT number): NCT00014729

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

Layout table for additonal information Identifier: NCT00014729     History of Changes
Other Study ID Numbers: 199/15738
First Posted: April 11, 2001    Key Record Dates
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:
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Epidermolysis Bullosa
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
Dermatologic Agents