A Substantial Equivalence Study of RD04723 and Predicate Device

Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars

The purpose of this study is to determine whether a developmental formulation is substantially equivalent to the predicate device in the treatment of hypertrophic and keloid scars.

Inclusion Criteria:

• Ability to provide informed consent and release health information
• Ability to follow study instructions and study requirements
• Have a hypertrophic or keloid scar accessible for treatment and evaluation
• Negative pregnancy test for women of childbearing potential
• Agreement to use effective birth control method for study duration

Exclusion Criteria:

• History of allergy or sensitivity to components
• History of diabetes
• History of collagen vascular disorders
• Anticipated need for surgery or hospitalization during the study
• Pregnant, nursing, or planning a pregnancy during the study
• Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)