Evaluation of five collagenase clostridium histolyticum-aaes injection techniques for the treatment of cellulite on the buttock or thigh.


Journal

Journal of cosmetic dermatology
ISSN: 1473-2165
Titre abrégé: J Cosmet Dermatol
Pays: England
ID NLM: 101130964

Informations de publication

Date de publication:
Apr 2022
Historique:
revised: 18 02 2022
received: 04 02 2022
accepted: 09 02 2022
pubmed: 13 2 2022
medline: 6 4 2022
entrez: 12 2 2022
Statut: ppublish

Résumé

Given differences in buttock versus thigh cellulite, collagenase clostridium histolyticum-aaes (CCH-aaes) injection technique may impact treatment effects at these sites. To evaluate efficacy and safety of 5 CCH-aaes injection techniques. A phase 2A, open-label trial enrolled women with mild-to-severe cellulite (Clinician Reported Photonumeric Cellulite Severity Scale) on both buttocks or thighs. CCH-aaes 0.84 mg was administered as 12 injections in each of two buttock or two thigh treatment areas (total dose, 1.68 mg) during three treatment sessions (Days 1, 22, 43). On Day 1, women were sequentially assigned to: Technique A = shallow injection/3 aliquots; Technique B = shallow injection/1 aliquot; Technique C = deep injection/1 aliquot; Technique D = deep and shallow injections/5 aliquots; or Technique E = shallow injection/4 aliquots. Change from baseline in Hexsel Cellulite Severity Scale (CSS) depression depth (range, 0 [no depressions] to 3 [deep depressions]) was assessed at Day 71. Safety was evaluated via adverse events. Sixty-three women with buttock (n = 31) or thigh (n = 32) cellulite received ≥1 CCH-aaes dose. For buttock cellulite, CCH-aaes injection Technique A resulted in the greatest baseline-adjusted improvement in CSS score on Day 71 (least-squares mean, 1.17-point improvement). For thigh cellulite, CSS score improvement was greatest with Technique D (least-squares mean, 1.40-point improvement). CCH injection Techniques A, D, and E were associated with more favorable safety profiles than Techniques B and C. Different CCH-aaes injection techniques are required with buttock (Technique A) versus thigh (Technique D) cellulite to optimize treatment outcomes.

Sections du résumé

BACKGROUND BACKGROUND
Given differences in buttock versus thigh cellulite, collagenase clostridium histolyticum-aaes (CCH-aaes) injection technique may impact treatment effects at these sites.
AIM OBJECTIVE
To evaluate efficacy and safety of 5 CCH-aaes injection techniques.
METHODS METHODS
A phase 2A, open-label trial enrolled women with mild-to-severe cellulite (Clinician Reported Photonumeric Cellulite Severity Scale) on both buttocks or thighs. CCH-aaes 0.84 mg was administered as 12 injections in each of two buttock or two thigh treatment areas (total dose, 1.68 mg) during three treatment sessions (Days 1, 22, 43). On Day 1, women were sequentially assigned to: Technique A = shallow injection/3 aliquots; Technique B = shallow injection/1 aliquot; Technique C = deep injection/1 aliquot; Technique D = deep and shallow injections/5 aliquots; or Technique E = shallow injection/4 aliquots. Change from baseline in Hexsel Cellulite Severity Scale (CSS) depression depth (range, 0 [no depressions] to 3 [deep depressions]) was assessed at Day 71. Safety was evaluated via adverse events.
RESULTS RESULTS
Sixty-three women with buttock (n = 31) or thigh (n = 32) cellulite received ≥1 CCH-aaes dose. For buttock cellulite, CCH-aaes injection Technique A resulted in the greatest baseline-adjusted improvement in CSS score on Day 71 (least-squares mean, 1.17-point improvement). For thigh cellulite, CSS score improvement was greatest with Technique D (least-squares mean, 1.40-point improvement). CCH injection Techniques A, D, and E were associated with more favorable safety profiles than Techniques B and C.
CONCLUSION CONCLUSIONS
Different CCH-aaes injection techniques are required with buttock (Technique A) versus thigh (Technique D) cellulite to optimize treatment outcomes.

Identifiants

pubmed: 35150194
doi: 10.1111/jocd.14842
pmc: PMC9305772
doi:

Substances chimiques

Microbial Collagenase EC 3.4.24.3

Types de publication

Clinical Trial, Phase II Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1448-1453

Subventions

Organisme : Endo Pharmaceuticals Inc.

Informations de copyright

© 2022 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.

Références

Dermatol Surg. 2009 Oct;35(10):1471-7
pubmed: 19614939
Plast Reconstr Surg Glob Open. 2020 Dec 23;8(12):e3316
pubmed: 33425621
Skin Res Technol. 2002 May;8(2):118-24
pubmed: 12060477
Dermatol Surg. 2020 Dec;46(12):1628-1635
pubmed: 33009069
Dermatol Surg. 2019 Aug;45(8):1047-1056
pubmed: 30829779
J Eur Acad Dermatol Venereol. 2009 May;23(5):523-8
pubmed: 19220646
J Cosmet Dermatol. 2022 Apr;21(4):1448-1453
pubmed: 35150194
Dermatol Surg. 2021 May 1;47(5):649-656
pubmed: 33840781

Auteurs

Joely Kaufman-Janette (J)

Coral Gables, Florida, USA.

Saji Vijayan (S)

Endo Pharmaceuticals Inc., Malvern, Pennsylvania, USA.

Qinfang Xiang (Q)

Endo Pharmaceuticals Inc., Malvern, Pennsylvania, USA.

Michael S Kaminer (MS)

Chestnut Hill, Massachusetts, USA.

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Classifications MeSH