PMID- 34608092
OWN - NLM
STAT- MEDLINE
DCOM- 20220105
LR  - 20230814
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Print)
IS  - 1076-0512 (Linking)
VI  - 48
IP  - 1
DP  - 2022 Jan 1
TI  - Efficacy and Safety of a New Resilient Hyaluronic Acid Filler in the Correction 
      of Moderate-to-Severe Dynamic Perioral Rhytides: A 52-Week Prospective, 
      Multicenter, Controlled, Randomized, Evaluator-Blinded Study.
PG  - 87-93
LID - 10.1097/DSS.0000000000003238 [doi]
AB  - BACKGROUND: The perioral region is highly mobile and subject to multifactorial 
      changes during aging. Resilient Hyaluronic Acid Redensity (RHAR), an RHA filler, 
      was developed with the aim of optimizing outcomes in dynamic facial areas. 
      OBJECTIVE: This randomized, blinded, multicenter clinical study aimed to 
      demonstrate superiority of RHAR over no-treatment control for correction of 
      moderate-to-severe dynamic perioral rhytides. MATERIALS AND METHODS: Blinded live 
      evaluator assessments of efficacy included improvement in perioral rhytides 
      severity using a proprietary scale (Perioral Rhytids Severity Rating Scale 
      [PR-SRS]) and the Global Aesthetic Improvement Scale. Subjects self-assessed 
      their results with FACE-Q, a validated patient-reported outcome measure, and 
      satisfaction scales. Safety was monitored throughout the study based on common 
      treatment responses (CTRs) and adverse events (AEs). RESULTS: The primary 
      efficacy end point was achieved, with the treatment group showing statistically 
      significant superiority over the control group at Week 8 (80.7% vs 7.8% responder 
      rate by PR-SRS, p < .0001). Most patients (66%) were still responders at Week 52 
      (study completion). Most AEs were CTRs after perioral injection of a dermal 
      filler, and none was a clinically significant treatment-related AE. CONCLUSION: 
      Resilient Hyaluronic Acid Redensity is effective and safe for the correction of 
      dynamic perioral rhytides in all Fitzpatrick phototypes, with marked durability.
CI  - Copyright (c) 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of the American Society for Dermatologic Surgery, Inc.
FAU - Sundaram, Hema
AU  - Sundaram H
AD  - Dermatology, Cosmetic, and Laser Surgery Center, Rockville, Maryland and Fairfax, 
      Virginia.
FAU - Shamban, Ava
AU  - Shamban A
AD  - ATS Clinical Research, Santa Monica, California.
FAU - Schlessinger, Joel
AU  - Schlessinger J
AD  - Skin Specialists PC, Omaha, Nebraska.
FAU - Kaufman-Janette, Joely
AU  - Kaufman-Janette J
AD  - Skin Research Institute, LLC, Coral Gables, Florida.
FAU - Joseph, John H
AU  - Joseph JH
AD  - Clinical Testing of Beverly Hills, Beverly Hills, California.
FAU - Lupin, Mark
AU  - Lupin M
AD  - Cosmedica Laser Center, Victoria, Canada.
FAU - Draelos, Zoe
AU  - Draelos Z
AD  - Dermatology Consulting Services, High Point, North Carolina.
FAU - Carey, Wayne
AU  - Carey W
AD  - Siena Medical Research Corporation, Montreal, Canada.
FAU - Smith, Stacy
AU  - Smith S
AD  - California Dermatology & Clinical Research Institute, Encinitas, California.
FAU - Eaton, Laura
AU  - Eaton L
AD  - UltaMed Corporation, Fort Lauderdale, Florida.
LA  - eng
SI  - ClinicalTrials.gov/NCT03092219
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 (Dermal Fillers)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Aged
MH  - Dermal Fillers/*administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Hyaluronic Acid/*administration & dosage/adverse effects/analogs & derivatives
MH  - Male
MH  - Middle Aged
MH  - Patient Reported Outcome Measures
MH  - Patient Satisfaction
MH  - Prospective Studies
MH  - Rhytidoplasty/*methods
MH  - Skin Aging/*drug effects
PMC - PMC8667798
EDAT- 2021/10/06 06:00
MHDA- 2022/01/06 06:00
PMCR- 2021/12/13
CRDT- 2021/10/05 05:51
PHST- 2021/10/06 06:00 [pubmed]
PHST- 2022/01/06 06:00 [medline]
PHST- 2021/10/05 05:51 [entrez]
PHST- 2021/12/13 00:00 [pmc-release]
AID - 00042728-202201000-00020 [pii]
AID - ds-00803-2020 [pii]
AID - 10.1097/DSS.0000000000003238 [doi]
PST - ppublish
SO  - Dermatol Surg. 2022 Jan 1;48(1):87-93. doi: 10.1097/DSS.0000000000003238.