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NCT00014729 Clinical Trial

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

Epidermolysis Bullosa Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00014729
Other study ID # 199/15738
Secondary ID UNCCH-FDR001796
Status Completed
Phase Phase 1
First received April 10, 2001
Last updated March 24, 2015
Start date October 2000
Est. completion date September 2002

Study information
Verified date May 2001
Source FDA Office of Orphan Products Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

OBJECTIVES:

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

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• isotretinoin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of North Carolina
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