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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Scar Prevention

Treatments: Drug: Placebo; Drug: EXC 001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01038297

EXC 001-201

B5301009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

EXC 001

Experimental group

Treatment:

Drug: EXC 001

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo