NCT00014729

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2000

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2001

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
Last Updated

March 25, 2015

Status Verified

May 1, 2001

First QC Date

April 10, 2001

Last Update Submit

March 24, 2015

Conditions

Epidermolysis Bullosa

Keywords

dermatologic disordersepidermolysis bullosagenetic diseases and dysmorphic syndromesrare disease

Interventions

isotretinoinDRUG

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Epidermolysis BullosaSkin DiseasesGenetic Diseases, InbornRare Diseases

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin and Connective Tissue DiseasesSkin Diseases, VesiculobullousDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Jo-David Fine

    University of North Carolina

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2001

First Posted

April 11, 2001

Study Start

October 1, 2000

Study Completion

September 1, 2002

Last Updated

March 25, 2015

Record last verified: 2001-05