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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary:

OBJECTIVES:

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

Detailed Summary:

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

Sponsor: University of North Carolina

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: FDA Office of Orphan Products Development

Dates:
Date Received: April 10, 2001
Date Started: October 2000
Date Completion: September 2002
Last Updated: March 24, 2015
Last Verified: May 2001