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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

isotretinoin

About this trial

This is an interventional treatment trial for Epidermolysis Bullosa focused on measuring dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00014729

First Posted

April 10, 2001

Last Updated

March 24, 2015

Sponsor

University of North Carolina

1. Study Identification

Unique Protocol Identification Number

NCT00014729

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2001

Overall Recruitment Status

Completed

Study Start Date

October 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of North Carolina

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epidermolysis Bullosa

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

isotretinoin

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jo-David Fine

Organizational Affiliation

University of North Carolina

Official's Role

Study Chair

Epidermolysis Bullosa

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial