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

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES:

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina
• Treatments: Isotretinoin

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