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

University of North Carolina20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Epidermolysis Bullosa

Interventions

isotretinoinDRUG

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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