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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	7 April 2015
Main ID:	NCT00014729
Date of registration:	10/04/2001
Prospective Registration:	No
Primary sponsor:	University of North Carolina
Public title:	Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa
Scientific title:
Date of first enrolment:	October 2000
Target sample size:	20
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00014729
Study type:	Interventional
Study design:	Primary Purpose: Treatment
Phase:	Phase 1

Countries of recruitment

Contacts

Name:	Jo-David Fine
Address:
Telephone:
Email:
Affiliation:	University of North Carolina

Key inclusion & exclusion 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

Age minimum: 15 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Epidermolysis Bullosa

Intervention(s)

Drug: isotretinoin

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

199/15738

UNCCH-FDR001796

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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