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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2002-09-30

Brief Summary

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OBJECTIVES:

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

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Detailed Description

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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

Conditions

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Epidermolysis Bullosa

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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isotretinoin

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No