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

Information source: FDA Office of Orphan Products Development
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epidermolysis Bullosa

Intervention: isotretinoin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of North Carolina

Official(s) and/or principal investigator(s):
Jo-David Fine, Study Chair, Affiliation: University of North Carolina

Summary

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

Clinical Details

Study design: Primary Purpose: Treatment

Detailed 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

Eligibility

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: October 2000
Last updated: March 24, 2015

Page last updated: August 23, 2015

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