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OpenTrials
Completed

NCT Number: NCT00014729

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

OBJECTIVES:

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

Completed

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Key information

Conditions

Epidermolysis Bullosa Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Genetic Diseases, Inborn Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

isotretinoin

Drug

Sponsors and collaborators

Lead sponsor

University of North Carolina

Other

Registry information

Important dates

Study start
2000
Study completion
2002
First posted
Apr 11, 2001
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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