Collagenase Clostridium Histolyticum-aaes for Treatment of Cellulite: A Pooled Analysis of Two Phase-3 Trials

Abstract

Cosmetic INTRODUCTIONCellulite is a condition characterized by alterations in skin topography, frequently described as dimpling, in affected areas. 1,2 Cellulite affects between 80% and 98% of postpubertal women, 2,3 and although not completely understood, 4,5 the pathophysiology of cellulite is multifactorial. Both collagen-rich fibrous septae and associated protrusions of subcutaneous adipose tissue play a role. 4,[6][7][8] Collagenase clostridium histolyticum-aaes (CCH-aaes; Qwo, Endo Aesthetics‚ LLC, Malvern, Pa.) was approved by the US Food and Drug Administration in 2020 for the treatment of moderate-to-severe cellulite in the buttocks of adult women. 9 CCH-aaes is composed of two purified bacterial collagenases [AUX-I and AUX-II (clostridial class I and II collagenases)] that hydrolyze Types I and III collagen with high specificity. 9,10 The CCH-aaes mechanism

Collagenase Clostridium Histolyticum-aaes Injections for Volumetric Change of Cellulite Dimples and Gluteal Contouring

“…Collagenase clostridium histolyticum-aaes-bacterial collagenases (AUX-I and AUX-II) specifically hydrolyze Type I and III collagen and are established as a safe and efficacious treatment option for the treatment of buttock cellulite based on validated cellulite scales. 3,9 In this retrospective image review, 3D imaging analysis was used to objectively and quantitatively confirm this clinical effect as it revealed a significant reduction in total dimple volume after dissolution of the fibrous septae with CHH. An average change in volume from baseline of 0.03 mL was observed at both Day 90 and Day 180 correlating to a 27% and 26% reduction in volume, respectively.…”

“…Collagenase clostridium histolyticum-aaes–bacterial collagenases (AUX-I and AUX-II) specifically hydrolyze Type I and III collagen and are established as a safe and efficacious treatment option for the treatment of buttock cellulite based on validated cellulite scales. 3,9…”

“…3,9 The injections were generally well tolerated, with the most common treatment-related adverse event being injection site bruising, pain, and nodules that improved with subsequent treatment sessions. 3,9…”

“…8 Subsequent Phase 3 trials validated these initial findings with significantly higher percentage of patients with improvement in the Clinician-Reported Photonumeric Cellulite Severity Scale and Patient-Reported Photonumeric Cellulite Severity Scale from baseline compared with placebo. 3,9 The injections were generally well tolerated, with the most common treatment-related adverse event being injection site bruising, pain, and nodules that improved with subsequent treatment sessions. 3,9 Past reports have demonstrated that vacuum-assisted subcision-a mechanical mode of disrupting the fibrous septae and thus improving cellulite-not only improves the depth of cellulite dimples and skin surface irregularities but also improves the contour of the buttock.…”

“…3,9 The injections were generally well tolerated, with the most common treatment-related adverse event being injection site bruising, pain, and nodules that improved with subsequent treatment sessions. 3,9 Past reports have demonstrated that vacuum-assisted subcision-a mechanical mode of disrupting the fibrous septae and thus improving cellulite-not only improves the depth of cellulite dimples and skin surface irregularities but also improves the contour of the buttock. 4,10 This volumetric change was quantified using 3-dimensional (3D) imaging, with a 67.4% average improvement in negative volume and 58.4% improvement in minimum height of dimples.…”