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: Reduction in Hypertrophic Skin Scarring

Treatments: Drug: EXC 001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01346969

B5301004

EXC 001-204

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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 the study.

Trial design

68 participants in 4 patient groups, including a placebo group

Group 1

Active Comparator group

Treatment:

Drug: EXC 001

Drug: EXC 001

Drug: EXC 001

Drug: EXC 001

Group 2

Placebo Comparator group

Treatment:

Drug: EXC 001

Drug: EXC 001

Drug: EXC 001

Drug: EXC 001

Group 3

Placebo Comparator group

Treatment:

Drug: EXC 001

Drug: EXC 001

Drug: EXC 001

Drug: EXC 001

Group 4

Placebo Comparator group

Treatment:

Drug: EXC 001

Drug: EXC 001

Drug: EXC 001

Drug: EXC 001