Characterization of Tissue Histology for the Injectable Cellulite Treatment Collagenase Clostridium Histolyticum-aaes: Results in Swine.

ABSTRACT

Background: Cellulite is a common aesthetic condition that affects predominantly females. Collagenase clostridium histolyticum-aaes (CCH-aaes) injections disrupt native collagen structures, resulting in an improvement in cellulite appearance. However, injection-site bruising is a frequently occurring adverse event with CCH-aaes treatment. Objectives: To characterize tissue histology following CCH-aaes injection in Yorkshire pigs. Methods: In an animal study, female swine with 10 defined dosing sites on the ventral-lateral aspect received 1 or 2 CCH-aaes (0.07 mg/0.3 mL) or placebo subcutaneous injections at a single site at designated time points before tissue sampling. Results: Injection with CCH-aaes was associated with lysis of mature, collagen-rich septa in the subcutaneous layer at and adjacent to the injection site as early as Day 1. On Day 4, an increase in inflammatory cells and a decrease in hemorrhage (vs Day 2) were observed, with inflammation and hemorrhage decreased by Day 8. By Day 21, deposition of new collagen and reorganization of fat lobules were observed. Observations with repeat CCH-aaes treatment were comparable with 1 course of CCH-aaes treatment. Conclusions: In this animal study, targeted enzymatic subcision of collagenous bands and remodeling of subcutaneous tissue were observed following CCH-aaes injection.