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

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Brief Title

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


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.

      Completion date provided represents the completion date of the grant per OOPD records
    

Study Phase

Phase 1

Study Type

Interventional




Condition

Epidermolysis Bullosa

Intervention

isotretinoin


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

Drug

Estimated Enrollment

20

Start Date

October 2000

Completion Date

September 2002


Eligibility 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
      

Gender

All

Ages

15 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jo-David Fine, , 



Administrative Informations


NCT ID

NCT00014729

Organization ID

199/15738

Secondary IDs

UNCCH-FDR001796


Study Sponsor

University of North Carolina


Study Sponsor

Jo-David Fine, Study Chair, University of North Carolina


Verification Date

May 2001