PMID- 33840781
OWN - NLM
STAT- MEDLINE
DCOM- 20210913
LR  - 20231208
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Print)
IS  - 1076-0512 (Linking)
VI  - 47
IP  - 5
DP  - 2021 May 1
TI  - Collagenase Clostridium Histolyticum-aaes for the Treatment of Cellulite in 
      Women: Results From Two Phase 3 Randomized, Placebo-Controlled Trials.
PG  - 649-656
LID - 10.1097/DSS.0000000000002952 [doi]
AB  - BACKGROUND: Fibrous septae play a role in contour alterations associated with 
      cellulite. OBJECTIVE: To assess collagenase clostridium histolyticum-aaes (CCH) 
      for the treatment of cellulite. MATERIALS AND METHODS: Two identically designed 
      phase 3, double-blind, randomized studies (RELEASE-1 and RELEASE-2) were 
      conducted. Adult women with moderate/severe cellulite (rating 3-4 on the Patient 
      Reported Photonumeric Cellulite Severity Scale [PR-PCSS] and Clinician Reported 
      PCSS [CR-PCSS]) on the buttocks received up to 3 treatment sessions of 
      subcutaneous CCH 0.84 mg or placebo per treatment area. Composite response 
      (>/=2-level or >/=1-level improvement from baseline in both PR-PCSS and CR-PCSS) was 
      determined at Day 71. RESULTS: Eight hundred forty-three women received >/=1 
      injection (CCH vs placebo: RELEASE-1, n = 210 vs n = 213; RELEASE-2, n = 214 vs n 
      = 206). Greater percentages of CCH-treated women were >/=2-level composite 
      responders versus placebo in RELEASE-1 (7.6% vs 1.9%; p = .006) and RELEASE-2 
      (5.6% vs 0.5%; p = .002) and >/=1-level composite responders in RELEASE-1 (37.1% vs 
      17.8%; p < .001) and RELEASE-2 (41.6% vs 11.2%; p < .001). Most adverse events 
      (AEs) in the CCH group were injection site related; few CCH-treated women 
      discontinued because of an AE (</=4.3%). CONCLUSION: Collagenase clostridium 
      histolyticum-aaes significantly improved cellulite appearance and was generally 
      well tolerated.
CI  - Copyright (c) 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of the American Society for Dermatologic Surgery.
FAU - Kaufman-Janette, Joely
AU  - Kaufman-Janette J
AD  - Skin Associates of South Florida, Coral Gables, Florida.
FAU - Joseph, John H
AU  - Joseph JH
AD  - John H. Joseph Facial Plastic and Reconstructive Surgery, Beverly Hills, 
      California.
FAU - Kaminer, Michael S
AU  - Kaminer MS
AD  - Dermatology, SkinCare Physicians, Chestnut Hill, Massachusetts.
FAU - Clark, James
AU  - Clark J
AD  - Charlottesville Medical Research, Charlottesville, Virginia.
FAU - Fabi, Sabrina G
AU  - Fabi SG
AD  - Cosmetic Laser Dermatology and University of California-San Diego, San Diego, 
      California.
FAU - Gold, Michael H
AU  - Gold MH
AD  - Department of Medicine, Division of Dermatology, Tennessee Clinical Research 
      Center, Nashville, Tennessee.
FAU - Goldman, Mitchel P
AU  - Goldman MP
AD  - Cosmetic Laser Dermatology and University of California-San Diego, San Diego, 
      California.
FAU - Katz, Bruce E
AU  - Katz BE
AD  - Juva Skin & Laser Center, New York, New York.
FAU - Peddy, Kappa
AU  - Peddy K
AD  - The Education & Research Foundation, Lynchburg, Virginia.
FAU - Schlessinger, Joel
AU  - Schlessinger J
AD  - Cosmetic Surgery, Skin Specialists P.C., Omaha, Nebraska.
FAU - Young, V Leroy
AU  - Young VL
AD  - Research, Mercy Health Research, Washington, Missouri.
FAU - Davis, Matthew
AU  - Davis M
AD  - Research and Development, Endo Pharmaceuticals Inc, Malvern, Pennsylvania.
FAU - Hurley, David
AU  - Hurley D
AD  - Medical Affairs, Endo Pharmaceuticals Inc, Malvern, Pennsylvania.
FAU - Liu, Genzhou
AU  - Liu G
AD  - Biostatistics, Endo Pharmaceuticals Inc, Malvern, Pennsylvania; and.
FAU - McLane, Michael P
AU  - McLane MP
AD  - Medical Affairs, Endo Pharmaceuticals Inc, Malvern, Pennsylvania.
FAU - Vijayan, Saji
AU  - Vijayan S
AD  - Research and Development, Endo Pharmaceuticals Inc, Malvern, Pennsylvania.
FAU - Bass, Lawrence S
AU  - Bass LS
AD  - Bass Plastic Surgery PLLC, New York, New York.
LA  - eng
SI  - ClinicalTrials.gov/NCT03428750
SI  - ClinicalTrials.gov/NCT03446781
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Dermatol Surg
JT  - Dermatologic surgery : official publication for American Society for Dermatologic 
      Surgery [et al.]
JID - 9504371
RN  - 0 (Antibodies, Neutralizing)
RN  - EC 3.4.24.3 (Microbial Collagenase)
SB  - IM
CIN - Dermatol Surg. 2021 May 1;47(5):657. PMID: 33625138
MH  - Antibodies, Neutralizing/blood
MH  - Cellulite/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Injection Site Reaction/etiology
MH  - Microbial Collagenase/adverse effects/immunology/*therapeutic use
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Treatment Outcome
PMC - PMC8078112
COIS- J. H. Joseph is a shareholder and an investigator for Endo Pharmaceuticals Inc. 
      J. Kaufman-Janette, M. S. Kaminer, M. H. Gold, B. E. Katz, J. Schlessinger, and 
      V. Leroy Young are investigators and consultants for Endo Pharmaceuticals Inc. J. 
      Clark and K. Peddy are also investigators for Endo Pharmaceuticals Inc. M. Davis, 
      D. Hurley, G. Liu, M. P. McLane, and S. Vijayan are employees of Endo 
      Pharmaceuticals Inc. L. S. Bass is an advisory board participant and consultant 
      for Endo Pharmaceuticals Inc. S. G. Fabi and M. P. Goldman received research 
      grants from Endo Pharmaceuticals Inc. V Leroy Young has also received 
      registration and travel expenses from Endo Pharmaceuticals Inc.
EDAT- 2021/04/13 06:00
MHDA- 2021/09/14 06:00
PMCR- 2021/04/27
CRDT- 2021/04/12 06:10
PHST- 2021/04/13 06:00 [pubmed]
PHST- 2021/09/14 06:00 [medline]
PHST- 2021/04/12 06:10 [entrez]
PHST- 2021/04/27 00:00 [pmc-release]
AID - 00042728-202105000-00018 [pii]
AID - ds-00787-2019 [pii]
AID - 10.1097/DSS.0000000000002952 [doi]
PST - ppublish
SO  - Dermatol Surg. 2021 May 1;47(5):649-656. doi: 10.1097/DSS.0000000000002952.