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

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF VARIOUS DOSES AND REGIMENS OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS FROM PRIOR BREAST SURGERY IN ADULT SUBJECTS (LEGACY EXCALIARD PROTOCOL # EXC 001-204)

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.

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.