Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

Completed · Phase 2

Conditions studied: Reduction in Hypertrophic Skin Scarring

In brief

The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.

Key facts

Study ID

NCT01346969

Run by

Pfizer

People needed

68

Starts

2011-06-01

Expected to finish

2012-04-16

Last updated by the study team

2021-09-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have previous had breast surgery resulting in unacceptable scars.
• Subject has chosen to have breast scars revised.
• Subject must not be pregnant or lactating.

You may not qualify if…

• Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or lactating.
• Participation in another clinical trial within 30 days prior to the start of the study.
• Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for the study.

Where it is running

• Skin Deep Laser Medical Spa — Pasadena, California, United States
• Bright Health Physicans Plastic Surgery and Aesthetic Medicine — Whittier, California, United States
• Altus Research — Lake Worth, Florida, United States
• Bayside Ambulatory Center — Miami, Florida, United States
• Aesthetic Plastic Surgery Miami — Miami, Florida, United States
• Body Aesthetic Plastic Surgery — St Louis, Missouri, United States
• New Jersey Plastic Surgery — Montclair, New Jersey, United States
• Mark L. Jewell,MD Surgery Center — Eugene, Oregon, United States
• Connall Consmetic Surgery — Tualatin, Oregon, United States
• Endeavor Clinical Trials,P.A. — San Antonio, Texas, United States
• Texas Plastic Surgery — San Antonio, Texas, United States
• BAXTER Plastic Surgery — Mountlake Terrace, Washington, United States

Full record on ClinicalTrials.gov

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