Oral Type I Collagen for Relieving Scleroderma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Diffuse systemic sclerosis (SSc), or scleroderma, is a connective tissue disease causing damage to skin and other organs. The purpose of this study is to determine if taking oral bovine type I collagen (CI) will improve the condition of SSc patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Collaborators: Baltimore VA Medical Center; Beth Israel Medical Center; Georgetown University; Johns Hopkins University; Medical University of South Carolina; Northwestern University; University of Alabama at Birmingham; University of California, Los Angeles; UTHSC; Wayne State University

Criteria

Inclusion Criteria:

• Clinical diagnosis of diffuse systemic scleroderma (by American College of Rheumatology criteria 1980) of 10 years or less

• Stable skin involvement by history or physical examination 6 months prior to study entry

• Stable modified Rodnan skin score (MRSS) for 1 month prior to study entry

• Stable MRSS of 16 or more at screening and stable MRSS between screening and baseline visit

• Agree to use acceptable forms of contraception

Exclusion Criteria:

• Participation in another clinical research study involving evaluation of another investigational drug within 90 days prior to study entry

• Concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study

• Systemic sclerosis-like illnesses associated with environmental, ingested, or injected agents, such as L-tryptophan, tainted rapeseed oil, vinyl chloride, or bleomycin

• Limited and localized (morphea) or linear SSc

• Tenderness or swelling of the extremities (eosinophilic fasciitis)

• Pregnancy

• Use of certain medications

• Allergy to beef or dairy products

• Nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week before baseline visit. Aspirin at 325 mg or less daily for stroke or heart attack prevention is allowed.

• Use of herbal and some alternative therapies

• Any organ transplant or stem cell transplant