PMID- 26230331
OWN - NLM
STAT- MEDLINE
DCOM- 20151116
LR  - 20151119
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Linking)
VI  - 41
IP  - 9
DP  - 2015 Sep
TI  - An Open-Label, Multicenter, Evaluator-Blinded Study to Assess the Efficacy and 
      Safety of a New Hyaluronic Acid-Based Gel Product for Lip Enhancement.
PG  - 1052-9
LID - 10.1097/DSS.0000000000000432 [doi]
AB  - BACKGROUND: A stabilized hyaluronic acid (HA)-based lidocaine-containing gel of 
      nonanimal origin has been developed for lip enhancement. OBJECTIVE: To evaluate 
      the efficacy, safety, and injection procedure of the HA gel in subjects seeking 
      lip enhancement. METHODS: Thirty subjects were treated in the upper and lower 
      lips. Retreatment was offered at 3 months. Efficacy was assessed over 9 months 
      using the Global Aesthetic Improvement Scale (GAIS), the Medicis Lip Fullness 
      Scale, and a subject questionnaire. Safety was assessed by a 14-day subject diary 
      and recording of adverse events (AEs) during the whole study. RESULTS: Over 9 
      months after treatment, 86% to 97% of subjects and independent evaluators 
      assessed both lips as improved. At all study visits, 72% to 93% of the subjects 
      were satisfied with their lips and >/=96% reported that their lips had a natural 
      look. Most AEs were mild-to-moderate local injection site reactions. CONCLUSION: 
      Lip enhancement with this HA-based gel generated high subject satisfaction and 
      natural-looking lips. The effect lasted for up to 9 months according to the GAIS 
      ratings by subjects and independent evaluators. The product was well tolerated; 
      most AEs were mild-to-moderate local injection site reactions.
FAU - Samuelson, Ulf
AU  - Samuelson U
AD  - *Akademikliniken, Stockholm, Sweden; daggerGoteborgs Plastikkirurgiska Center, 
      Goteborg, Sweden; double daggerPCG Clinical Services AB, Uppsala, Sweden;  section signHealthy 
      Communication, London, United Kingdom;  ||Stureplanskliniken, Stockholm, Sweden.
FAU - Fagrell, Dan
AU  - Fagrell D
FAU - Wetter, Anne
AU  - Wetter A
FAU - Kuusk, Sandra
AU  - Kuusk S
FAU - Hamilton, Lynn
AU  - Hamilton L
FAU - Haglund, Pyra
AU  - Haglund P
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Dermatol Surg
JT  - Dermatologic surgery : official publication for American Society for Dermatologic 
      Surgery [et al.]
JID - 9504371
RN  - 0 (Anesthetics, Local)
RN  - 0 (Biocompatible Materials)
RN  - 0 (Gels)
RN  - 9004-61-9 (Hyaluronic Acid)
RN  - 98PI200987 (Lidocaine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anesthetics, Local/therapeutic use
MH  - Biocompatible Materials/therapeutic use
MH  - *Cosmetic Techniques
MH  - Esthetics
MH  - Female
MH  - Gels
MH  - Humans
MH  - Hyaluronic Acid/*therapeutic use
MH  - Injections
MH  - Lidocaine/therapeutic use
MH  - *Lip
MH  - Middle Aged
MH  - Patient Safety
MH  - Patient Satisfaction
MH  - Retreatment
MH  - Surveys and Questionnaires
EDAT- 2015/08/01 06:00
MHDA- 2015/11/17 06:00
CRDT- 2015/08/01 06:00
PHST- 2015/08/01 06:00 [entrez]
PHST- 2015/08/01 06:00 [pubmed]
PHST- 2015/11/17 06:00 [medline]
AID - 10.1097/DSS.0000000000000432 [doi]
PST - ppublish
SO  - Dermatol Surg. 2015 Sep;41(9):1052-9. doi: 10.1097/DSS.0000000000000432.