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 EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS RESULTING FROM PRIOR BREAST SURGERY IN ADULT FEMALE SUBJECTS

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.

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