PMID- 23545926
OWN - NLM
STAT- MEDLINE
DCOM- 20130920
LR  - 20140731
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 12
IP  - 3
DP  - 2013 Mar
TI  - The evaluation of hyaluronic acid, with and without lidocaine, in the filling of 
      nasolabial folds as measured by ultrastructural changes and pain management.
PG  - e46-52
AB  - BACKGROUND: Pain management is an important objective in procedures involving 
      dermal fillers composed of hyaluronic acid (HA). OBJECTIVE: To compare the 1-year 
      clinical results of filling the nasolabial fold with 2 types of filler: large-gel 
      particle HA and large-gel particle HA plus 0.3% lidocaine (HA+L). We compared the 
      level of pain during treatment and 10 minutes after treatment and assessed the 
      safety and efficacy profile, satisfaction, and histological findings (using 
      reflectance confocal microscopy [RCM]). MATERIALS AND METHODS: We performed a 
      comparative, parallel-group, double-blind trial with an external observer 
      (blinded to the type of treatment administered). The filler was applied to the 
      nasolabial fold in 119 patients (HA in 62 patients and HA+L in 57). Patients were 
      followed at months 3, 9, and 12. Pain was evaluated using a visual analog scale. 
      Efficacy and satisfaction were evaluated using the Wrinkle Severity Rating Scale 
      and the Global Aesthetic Improvement Scale. RCM images (n=32) were taken at 
      baseline and at months 3 and 12. RESULTS: Pain: The severity of pain was 
      decreased in patients treated with HA+L on application (P <.001) and 10 minutes 
      later ( P=.008). Efficacy and satisfaction: No significant differences existed 
      between the 2 groups at months 3, 9, and 12. RCM: Skin rejuvenation occurred with 
      a 32% increase in the height of the dermoepidermal junction at month 12 (P 
      <.001), which was similar in both groups. Adverse events: At month 3, the most 
      common adverse events (AEs) were erythema (68%) and hematoma (11%). No AEs were 
      recorded at months 9 or 12. CONCLUSION: The use of HA+L provides pain relief 
      without affecting efficacy, satisfaction, safety, or the duration of results. RCM 
      showed that the changes in the dermoepidermal junction represented a histological 
      improvement in the skin with similar results in both groups.
FAU - Royo de la Torre, Josefina
AU  - Royo de la Torre J
AD  - Servicio de Dermatologia, Instituto Medico Laser, Madrid, Spain. consulta@iml.es
FAU - Moreno-Moraga, J
AU  - Moreno-Moraga J
FAU - Isarria, Maria J
AU  - Isarria MJ
FAU - Munoz, Estefania
AU  - Munoz E
FAU - Cruz, Irene
AU  - Cruz I
FAU - Perez, Gema
AU  - Perez G
FAU - Cornejo, Paloma
AU  - Cornejo P
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Anesthetics, Local)
RN  - 0 (Gels)
RN  - 9004-61-9 (Hyaluronic Acid)
RN  - 98PI200987 (Lidocaine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anesthetics, Local/administration & dosage/adverse effects
MH  - *Cosmetic Techniques/adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Gels
MH  - Humans
MH  - Hyaluronic Acid/*administration & dosage/adverse effects
MH  - Lidocaine/*administration & dosage/adverse effects
MH  - Male
MH  - Microscopy, Confocal
MH  - Middle Aged
MH  - Nasolabial Fold
MH  - Pain/*drug therapy/etiology
MH  - Pain Measurement
MH  - Patient Satisfaction
MH  - Rejuvenation
MH  - Severity of Illness Index
MH  - Skin Aging
MH  - Time Factors
EDAT- 2013/04/03 06:00
MHDA- 2013/09/21 06:00
CRDT- 2013/04/03 06:00
PHST- 2013/04/03 06:00 [entrez]
PHST- 2013/04/03 06:00 [pubmed]
PHST- 2013/09/21 06:00 [medline]
AID - S1545961613E0046X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2013 Mar;12(3):e46-52.