PMID- 34417392
OWN - NLM
STAT- MEDLINE
DCOM- 20211228
LR  - 20230814
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Linking)
VI  - 47
IP  - 10
DP  - 2021 Oct 1
TI  - Safety of Cohesive Polydensified Matrix Cross-Linked Hyaluronic Acid Volumizing 
      Gel in Temporal Hollows and Cheeks: A Prospective, Open-Label, Postmarket Study.
PG  - 1359-1364
LID - 10.1097/DSS.0000000000003176 [doi]
AB  - BACKGROUND: Facial aging is characterized by volume loss and progressive 
      hollowing of temples and cheeks. Biodegradable filler materials are preferred 
      over nonabsorbable materials; of these, hyaluronic acid (HA) fillers are the most 
      often used because of their favorable effectiveness and safety profile. 
      OBJECTIVE: To confirm the safety and effectiveness of Cohesive Polydensified 
      Matrix (CPM)-HA26 gel in the treatment of volume deficiency. METHODS: Subjects 
      received up to 2 treatments in the temples and/or cheeks. A blinded investigator 
      assessed improvement according to the Merz Temple Volume Scale (MTVS) and Merz 
      Cheek Fullness Assessment Scale (MCFAS). Subjects were followed for 48 weeks 
      after the last treatment. RESULTS: In total, 87 healthy subjects were enrolled. 
      The proportion of subjects achieving at least a 1-grade improvement on MTVS 
      and/or MCFAS was above 70% for each (MTVS: Weeks 4, 24, and 48 = 95.4%, 94.2%, 
      and 77.0%; MCFAS: Weeks 4, 24, and 48 = 92.3%, 83.1%, and 71.8%). Based on MTVS 
      and MCFAS scores at Visit 5, improvement remained visible at up to 48 weeks. No 
      treatment-related serious AEs occurred. CONCLUSION: CPM-HA26 demonstrated both a 
      favorable safety and effectiveness profile, with improvement in facial volume 
      evident for up to 48 weeks. It was well tolerated and had a positive, 
      long-lasting effect.
CI  - Copyright (c) 2021 by the American Society for Dermatologic Surgery, Inc. Published 
      by Wolters Kluwer Health, Inc. All rights reserved.
FAU - Pavicic, Tatjana
AU  - Pavicic T
AD  - Privatpraxis fur Dermatologie und Asthetik Maximilianstr, Munich, Germany.
FAU - Sattler, Gerhard
AU  - Sattler G
AD  - Rosenparkklinik GmbH, Darmstadt, Germany.
FAU - Prager, Welf
AU  - Prager W
AD  - Prager & Partner Dermatologische Praxis, Hamburg, Germany.
FAU - Fischer, Tanja
AU  - Fischer T
AD  - Haut-und Lasercentrum Berlin-Potsdam, Praxis Potsdam, Potsdam, Germany.
FAU - Gauglitz, Gerd
AU  - Gauglitz G
AD  - Dermatologie Munchen-Neuhausen, Leonrodstrasse, Munich, Germany.
FAU - Hofmann, Matthias
AU  - Hofmann M
AD  - Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.
FAU - Dersch, Hanna
AU  - Dersch H
AD  - Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.
FAU - Riaz, Shahbaz
AU  - Riaz S
AD  - Merz North America, Inc., Raleigh, North Carolina.
FAU - Kerscher, Martina
AU  - Kerscher M
AD  - Division of Biochemistry and Molecular Biology, Cosmetic Science, University of 
      Hamburg, Hamburg, Germany.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - United States
TA  - Dermatol Surg
JT  - Dermatologic surgery : official publication for American Society for Dermatologic 
      Surgery [et al.]
JID - 9504371
RN  - 0 (Dermal Fillers)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Adult
MH  - Aging
MH  - Cheek
MH  - Cosmetic Techniques/*adverse effects
MH  - Dermal Fillers/administration & dosage/*adverse effects/chemistry
MH  - Female
MH  - Follow-Up Studies
MH  - Healthy Volunteers
MH  - Humans
MH  - Hyaluronic Acid/administration & dosage/*adverse effects/chemistry
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Treatment Outcome
EDAT- 2021/08/22 06:00
MHDA- 2021/12/29 06:00
CRDT- 2021/08/21 05:36
PHST- 2021/08/22 06:00 [pubmed]
PHST- 2021/12/29 06:00 [medline]
PHST- 2021/08/21 05:36 [entrez]
AID - 00042728-202110000-00008 [pii]
AID - 10.1097/DSS.0000000000003176 [doi]
PST - ppublish
SO  - Dermatol Surg. 2021 Oct 1;47(10):1359-1364. doi: 10.1097/DSS.0000000000003176.