Human Pharmacokinetics and Safety of Subcutaneous Collagenase Clostridium Histolyticum in Women

Abstract

At the time the studies were conducted. Background: Clostridium collagenase histolyticum (CCH) is being evaluated in women as a cellulite treatment. Objective: To report preclinical safety and human pharmacokinetics (PK) and safety data for CCH. Methods: Across 3 PK studies, 41 women received 12 subcutaneous injections per thigh/buttock in 1 session (up to 3.36 mg/dose).

Nonsurgical fat reduction: Cryolipolysis, RF skin tightening, HIFEM, and injectable lipolysis

“…56 Adverse events included injection site-related bruising (97.6%), pain (87.8%), edema (46.3%), and no quantifiable circulating CCH levels were observed after a single dose of CCH up to 3.36 mg. In conclusion of the study by Bhatia et al 56 preclinical data indicated that repeat intravenous dosing every other day, a total of eight doses (43× proposed human dose) on mg/kg for CCH was generally well tolerated. 56 Injectable CCH is a new injection technique for women with moderate-to severe cellulite in the buttocks of women.…”

“…Cellulite is a localized alteration of skin with dimpling that affects 80%-98% of postpubertal women of all ethnicities and ages. 56,57 Data suggest that the collagen-rich fibrous septae play a role in structure, in addition to subcutaneous edema, decreased dermal thickness with age, fibrogenesis, and adipose protrusion. 56,57 Clostridium collagenase histolyticum (CCH) is composed of two purified collagenases and enzymatically releases this fibrous septae by targeting type I and II collagen.…”

“…56,57 Data suggest that the collagen-rich fibrous septae play a role in structure, in addition to subcutaneous edema, decreased dermal thickness with age, fibrogenesis, and adipose protrusion. 56,57 Clostridium collagenase histolyticum (CCH) is composed of two purified collagenases and enzymatically releases this fibrous septae by targeting type I and II collagen. 58 CCH was approved by the US FDA on July 6, 2020 for the treatment of moderate-to-severe cellulite in the buttocks of women.…”

“…58 CCH has been studied in 11 clinical trials of cellulite (n = 1027) with up to 4 years of follow-up. 58 CCH was recently studied on human pharmacokinetics (PK) and safety data for CCH across three PK studies by Bhatia et al 56 The results showed in PK studies, no plasma concentrations in studies AUX-1 or AUX-II were observed post-dose. 56 Adverse events included injection site-related bruising (97.6%), pain (87.8%), edema (46.3%), and no quantifiable circulating CCH levels were observed after a single dose of CCH up to 3.36 mg.…”

“…58 CCH was recently studied on human pharmacokinetics (PK) and safety data for CCH across three PK studies by Bhatia et al 56 The results showed in PK studies, no plasma concentrations in studies AUX-1 or AUX-II were observed post-dose. 56 Adverse events included injection site-related bruising (97.6%), pain (87.8%), edema (46.3%), and no quantifiable circulating CCH levels were observed after a single dose of CCH up to 3.36 mg. In conclusion of the study by Bhatia et al 56 preclinical data indicated that repeat intravenous dosing every other day, a total of eight doses (43× proposed human dose) on mg/kg for CCH was generally well tolerated.…”