Objectives: The aim of the study was to evaluate the pain associated with injection of hyaluronic acid filler, HARL with lidocaine compared to HARL without lidocaine, for correction of moderate to severe nasolabial folds.
The proportion of subjects that had a within-subject difference in visual analogue scale (VAS) score of at least 10 mm at injection was calculated together with a two-sided 95% confidence interval. The objective was to show that the confidence interval was above 50%.
Secondary objectives were evaluation of effectiveness and safety of the study products.
Introduction: Based on previous clinical experience in EU and US, the addition of lidocaine hydrochloride to hyaluronic acid filler HARL, used for e.g. correction of nasolabial folds, provides substantial pain relief for patients during treatment. It is important to provide clinical data on the pain-relieving effect of adding lidocaine to HARL in Asian subjects as well.
Materials / method: This was a randomized, multi-center, evaluator-blinded, 2-week study conducted in Taiwan
Each subject received HARL with 3% lidocaine in one nasolabial fold and HARL without lidocaine in the other. Recommended maximum volume to achieve optimal correction was 2.0 mL for each side
Subjects assessed the pain experienced on a 100 mm VAS at the end of each injection and at 15, 30, 45, and 60 minutes after injection
Aesthetic improvement and nasolabial fold wrinkle severity was assessed
Pre-defined symptoms were recorded during 14 days after treatment
using a diary, and adverse events were collected
Results: Demographics and treatments
Effectiveness on Visual Analogue Scale, Wrinkle Severity Rating Scale, Global Aesthetic Improvement Scale
Safety on subject dairy entries of pre-defined, post-treatment symptoms and adverse events
Conclusion: HARL with lidocaine had a substantial effect on pain relief in Asian subjects undergoing correction of nasolabial folds, without affecting the safety profile, and with maintained improvement in nasolabial fold wrinkle severity and aesthetic appearance.
Did you receive any funding to support your research for this TOPIC?
Were you provided with any honoraria, payment or other compensation for your work on this study?
Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
This work was not supported by any direct or non direct funding. It is under the author's own responsability