PMID- 38439998
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240306
IS  - 2168-8184 (Print)
IS  - 2168-8184 (Electronic)
IS  - 2168-8184 (Linking)
VI  - 16
IP  - 2
DP  - 2024 Feb
TI  - Real-World Outcomes of Lip Augmentation Using a Hyaluronic Acid-Based Filler With 
      Low 1,4-Butanediol Diglycidyl Ether Content: A Prospective, Open-Label, 
      Multicenter, Post-marketing Study.
PG  - e53513
LID - 10.7759/cureus.53513 [doi]
LID - e53513
AB  - Background 1,4-butanediol diglycidyl ether (BDDE) is the most common cross-linker 
      used to produce hyaluronic acid (HA)-based dermal fillers. However, BDDE may have 
      cytotoxic and potentially mutagenic effects, raising safety concerns. 
      Consequently, manufacturers are developing new HA filler formulations with 
      reduced BDDE levels to mitigate potential biological risks. Here, we sought to 
      evaluate the clinical outcomes of lip augmentation performed using an HA-based 
      filler with a reduced BDDE content (Agex Fill Volume((R)); Biodue SpA, Barberino 
      Tavarnelle, Italy) in a real-world clinical setting. Methods This was a 
      prospective, open-label, multicenter, post-marketing study conducted over six 
      months. Thirty adult subjects (29 women and one man) who desired a >/=1-point 
      improvement on the validated Lip Fullness Scale 2 (LFS2) were enrolled. The 
      primary efficacy endpoint was the post-procedural increase in the 
      investigator-reported LFS2 compared to baseline. Other endpoints included 
      self-perceived happiness assessed using the Happiness Measure Scale (HMS) and 
      safety. Results Of the study participants, 73% (22/30) demonstrated an 
      improvement of at least one point in their LFS2 scores immediately after 
      treatment compared to baseline, thus qualifying as responders. Six months later, 
      the responder rate, based on LFS2 scores, remained steady at 66.7% (20/30). 
      Importantly, these aesthetic improvements were consistently associated with a 
      positive impact on subject-reported HMS, with a significant difference (p < 
      0.001) between post-treatment and baseline scores. All adverse events (AEs) 
      reported after treatment were mild. Conclusions Agex Fill Volume((R)), a HA filler 
      with low BDDE content, provides a safe and effective option for enhancing lip 
      volume in real-world aesthetic settings.
CI  - Copyright (c) 2024, Massidda et al.
FAU - Massidda, Enrico
AU  - Massidda E
AD  - Dermatology, Italian Society of Aesthetic Medicine, Cagliari, ITA.
FAU - Ciampa, Sonia
AU  - Ciampa S
AD  - Dermatology, Poliambulatorio Rimedical, Santarcangelo di Romagna, ITA.
FAU - Iozzo, Ivano
AU  - Iozzo I
AD  - Dermatology, Iozzo Antonucci Medical Center, Bologna, ITA.
FAU - Emanuele, Enzo
AU  - Emanuele E
AD  - Clinical Pathology, 2E Science, Robbio, ITA.
FAU - Minoretti, Piercarlo
AU  - Minoretti P
AD  - Occupational Health, Studio Minoretti, Oggiono, ITA.
LA  - eng
PT  - Journal Article
DEP - 20240203
PL  - United States
TA  - Cureus
JT  - Cureus
JID - 101596737
PMC - PMC10911686
OTO - NOTNLM
OT  - butanediol diglycidyl ether
OT  - dermal fillers
OT  - hyaluronic acid
OT  - lip augmentation
OT  - real-world aesthetic practice
COIS- The authors have declared that no competing interests exist.
EDAT- 2024/03/05 06:47
MHDA- 2024/03/05 06:48
PMCR- 2024/02/03
CRDT- 2024/03/05 03:47
PHST- 2024/02/03 00:00 [accepted]
PHST- 2024/03/05 06:48 [medline]
PHST- 2024/03/05 06:47 [pubmed]
PHST- 2024/03/05 03:47 [entrez]
PHST- 2024/02/03 00:00 [pmc-release]
AID - 10.7759/cureus.53513 [doi]
PST - epublish
SO  - Cureus. 2024 Feb 3;16(2):e53513. doi: 10.7759/cureus.53513. eCollection 2024 Feb.