Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty

Completed · Phase 2 · Has a placebo group

Conditions studied: Scar Prevention

In brief

This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.

Key facts

Study ID

NCT01038297

Run by

Pfizer

People needed

30

Starts

2009-12-01

Expected to finish

2010-07-07

Last updated by the study team

2021-09-20

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty
• Subject has chosen to have an elective abdominoplasty
• Medically healthy with normal screening results
• Subjects must not be pregnant or lactating

You may not qualify if…

• Subjects with existing scars or significant striae on the abdominal pannus
• Females who are currently pregnant or pregnant during the 12 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 this study

Where it is running

• Northwestern University,Division of Plastic Surgery — Chicago, Illinois, United States
• Body Aesthetic Plastic Surgery — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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