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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Scar Prevention

Treatments: Drug: Placebo; Drug: EXC 001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037413

B5301011 (Other Identifier)

EXC 001-203

Details and patient eligibility

About

This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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 this study

Trial design

25 participants in 2 patient groups, including a placebo group

EXC 001

Experimental group

Treatment:

Drug: EXC 001

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo