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

University of North Carolina (UNC)

Status and phase: Completed; Phase 1

Conditions: Epidermolysis Bullosa

Treatments: Drug: isotretinoin

Study type: Interventional

Funder types: Other

Identifiers

NCT00014729

UNCCH-FDR001796

199/15738

Details and patient eligibility

About

OBJECTIVES:

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

Full 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

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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