KLI

The efficacy and safety of BM-PHA for the correction of nasolabial folds: a multicenter, randomized, double-blind, split-face clinical trial

Metadata Downloads
Abstract
Background: Multiple types of fillers have been developed for soft tissue augmentation.Objective: We investigated the efficacy and safety of the novel filler BM-PHA.Methods: In this multicenter, randomized, split-face study, 91 participants received injections of BM-PHA and Restylane Perlane (PER) into the nasolabial folds. Efficacy was determined by the improvements in the Wrinkle Severity Rating Score (WSRS) and Global Esthetic Improvement Scale (GAIS), and safety by adverse events, laboratory tests, and a check of vital signs.Results: WSRS scores assessed by independent evaluators at Week 24, the primary efficacy measure, showed no significant difference between the two treatments. The treatments also showed no significant differences in WSRS scores assessed by the evaluators at Week 8 and WSRS and GAIS scores assessed by the treating investigators and participants at Weeks 8 and 24. The proportion of nasolabial folds whose WSRS scores improved by at least one grade at Week 24 was similar between the treatments. Only minor local side effects were reported without sequelae.Conclusion: BM-PHA was not inferior to PER in the treatment of moderate to severe nasolabial folds and may be an appropriate alternative product for their improvement. Further studies are needed to confirm the long-term safety of BM-PHA.

Keywords: BM-PHA; hyaluronic acid; nasolabial fold
Author(s)
김범준백승환원종현이미우이우진장성은최명은최지호
Issued Date
2021
Type
Article
Keyword
AdultBM-PHAcosmetic TechniquesDermal Fillers - administration & dosageDermal Fillers - adverse effectsDouble-Blind MethodFemaleHumanshyaluronic acidHyaluronic Acid - administration & dosageHyaluronic Acid - adverse effectsInjectionsIntradermalMaleMiddle Agednasolobial foldasolobial fold - pathologyPain - etiologySkin AgingTreatment Outcome
DOI
10.1080/09546634.2019.1623859
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8329
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_informaworld_taylorfrancis_310_1080_09546634_2019_1623859&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,The%20efficacy%20and%20safety%20of%20BM-PHA%20for%20the%20correction%20of%20nasolabial%20folds:%20a%20multicenter,%20randomized,%20double-blind,%20split-face%20clinical%20trial&offset=0&pcAvailability=true
Publisher
JOURNAL OF DERMATOLOGICAL TREATMENT
Location
일본
Language
한국어
ISSN
0954-6634
Citation Volume
32
Citation Number
1
Citation Start Page
95
Citation End Page
100
Appears in Collections:
Medicine > Medicine
Authorize & License
  • Authorize공개
Files in This Item:
  • There are no files associated with this item.

Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated.