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

Condition	Treatment or Intervention	Phase
Epidermolysis Bullosa	Drug: isotretinoin	Phase I

Further Study Details: 

Expected Total Enrollment:  20

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

Ages Eligible for Study:  15 Years and above,  Genders Eligible for Study:  Both

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

Study chairs or principal investigators

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

Study ID Numbers:  199/15738; UNCCH-FDR001796
Record last reviewed:  May 2001
Last Updated:  October 13, 2004
Record first received:  April 10, 2001
ClinicalTrials.gov Identifier:  NCT00014729
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08