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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00014729

Enrollment

Registered

2001-04-11

Start date

2000-10-31

Completion date

2002-09-30

Last updated

2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidermolysis Bullosa

Keywords

dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease

Brief summary

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

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

Interventions

DRUGisotretinoin

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026