PMID- 35419911
OWN - NLM
STAT- MEDLINE
DCOM- 20220714
LR  - 20221205
IS  - 1529-8019 (Electronic)
IS  - 1396-0296 (Linking)
VI  - 35
IP  - 7
DP  - 2022 Jul
TI  - A randomized, participant- and evaluator-blinded, matched-pair prospective study 
      to compare the safety and efficacy between polycaprolactone-based fillers in the 
      correction of nasolabial folds.
PG  - e15508
LID - 10.1111/dth.15508 [doi]
AB  - Polycaprolactone (PCL)-based fillers are widely used for skin rejuvenation and 
      wrinkle reduction. The objective of this study is to compare the efficacy and 
      safety of newly developed PCL-based fillers (SYB filler(R); SF-01) and widely used 
      existing PCL-based fillers (Ellanse-M(R)) for correction of moderate-to-severe 
      nasolabial folds. In a randomized, participant-and evaluator-blinded, 
      matched-pair, prospective study, participants were randomized for injections of 
      SF-01 or Ellanse-M(R) in both nasolabial folds. Efficacy was evaluated using the 
      Wrinkle Severity Rating Scale (WSRS), Global Esthetic Improvement Scale (GAIS), 
      and a three-dimensional (3D) scanner. All adverse events (AEs) were examined and 
      reported. At month 12, both SF-01-and Ellanse-M(R)-treated groups showed 
      statistically significant improvements in the WSRS, GAIS, and 3D scanner scores 
      compared to baseline. The difference in changes in WSRS scores at month 12 
      between the two groups was 0.08 +/- 0.34 compared to baseline. The upper limit of 
      the 95.0% confidence interval was 0.0031, which was lower than the predefined 
      margin for non-inferiority (0.35). All AEs were injection site-related (swelling, 
      pain, and erythema) and disappeared within 30 min after the procedure. SF-01 was 
      non-inferior to Ellanse-M(R) and demonstrated favorable efficacy and safety at 
      12 months after correcting moderate-to-severe nasolabial folds.
CI  - (c) 2022 Wiley Periodicals LLC.
FAU - Park, Jae Wan
AU  - Park JW
AUID- ORCID: 0000-0003-2690-6495
AD  - Department of Dermatology, College of Medicine, Chung-Ang University Hospital, 
      Seoul, Republic of Korea.
FAU - Choi, Sun Young
AU  - Choi SY
AUID- ORCID: 0000-0003-0248-7708
AD  - Department of Dermatology, College of Medicine, Chung-Ang University Hospital, 
      Seoul, Republic of Korea.
FAU - Kim, Ka Ram
AU  - Kim KR
AUID- ORCID: 0000-0002-5696-4699
AD  - Department of Dermatology, College of Medicine, Chung-Ang University Hospital, 
      Seoul, Republic of Korea.
FAU - Jin, Miryung
AU  - Jin M
AUID- ORCID: 0000-0002-7343-9765
AD  - Clinical and Regulatory Affairs Team, Samyang Holdings Corp, Gyeonggi, Republic 
      of Korea.
FAU - Seok, Joon
AU  - Seok J
AUID- ORCID: 0000-0002-8016-8385
AD  - Department of Dermatology, College of Medicine, Chung-Ang University Hospital, 
      Seoul, Republic of Korea.
FAU - Yoo, Kwang Ho
AU  - Yoo KH
AUID- ORCID: 0000-0002-0137-6849
AD  - Department of Dermatology, Chung-Ang University Gwangmyeong Hospital, Chung-Ang 
      University College of Medicine, Gwangmyeong, Gyeonggi, Republic of Korea.
FAU - Kim, Beom Joon
AU  - Kim BJ
AUID- ORCID: 0000-0003-2320-7621
AD  - Department of Dermatology, College of Medicine, Chung-Ang University Hospital, 
      Seoul, Republic of Korea.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220425
PL  - United States
TA  - Dermatol Ther
JT  - Dermatologic therapy
JID - 9700070
RN  - 0 (Dermal Fillers)
RN  - 0 (Polyesters)
RN  - 24980-41-4 (polycaprolactone)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - *Cosmetic Techniques/adverse effects
MH  - *Dermal Fillers/adverse effects
MH  - Humans
MH  - Hyaluronic Acid
MH  - Nasolabial Fold
MH  - Polyesters
MH  - Prospective Studies
MH  - *Skin Aging
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Ellanse-M(R)
OT  - SF-01
OT  - augmentation
OT  - filler
OT  - nasolabial fold
OT  - polycaprolactone
EDAT- 2022/04/15 06:00
MHDA- 2022/07/15 06:00
CRDT- 2022/04/14 05:24
PHST- 2022/03/25 00:00 [received]
PHST- 2022/04/10 00:00 [accepted]
PHST- 2022/04/15 06:00 [pubmed]
PHST- 2022/07/15 06:00 [medline]
PHST- 2022/04/14 05:24 [entrez]
AID - 10.1111/dth.15508 [doi]
PST - ppublish
SO  - Dermatol Ther. 2022 Jul;35(7):e15508. doi: 10.1111/dth.15508. Epub 2022 Apr 25.