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 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 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 was observed. Observations with repeat CCH-aaes treatment were comparable with one course of CCH-aaes treatment. Conclusion In this animal study, targeted enzymatic subcision of collagenous bands and remodeling of subcutaneous tissue was observed following CCH-aaes injection.

Real‐world effectiveness and safety of collagenase clostridium histolyticum‐aaes injections for the treatment of thigh cellulite in women: An open‐label study interim analysis

“…These studies have shown that CCH-aaes injection lyses the pathogenic mature collagen-rich septae and also stimulates neocollagenesis (i.e., remodeling) and reorganization of subcutaneous adipose tissue (i.e., smaller and more homogenous fat lobules). 12 To date, studies of CCH-aaes have focused on the treatment of moderate-to-severe forms of cellulite, defined using the validated Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 13 as a score of 3 (moderate) or 4 (severe). 11,14 A phase 2, randomized, double-blind, placebo-controlled study (n = 375) of women with moderate-to-severe cellulite of the buttocks and/or posterolateral thighs found that treatment with subcutaneous CCH-aaes injections significantly improved the appearance of cellulite compared with placebo.…”