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Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa Clinical research trials and Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa. Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

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



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

For Condition: Epidermolysis Bullosa
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , University of North Carolina
Synopsis: OBJECTIVES: I. Determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis bullosa.
Details: PROTOCOL OUTLINE: Patients receive oral isotretinoin daily for 8 months in the absence of disease progression or unacceptable toxicity.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 20

Location and Contact Information:

Overall Study Official:
Jo-DavidFine,  Study Chair,  University of North Carolina


Additional Information:
Study ID Numbers:
  199/15738;  UNCCH-FDR001796
Study Start Date: October 2000
Record last reviewed: May 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014729

Other Epidermolysis Bullosa Studies:
1. Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa

2. Study of the Nutritional, Metabolic, and Body Composition Profile in Children and Adolescents with Epidermolysis Bullosa

3. Establishment of the National Epidermolysis Bullosa Registry

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