N/A
Completed N=70
Pain and Safety of Restylane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds
Nasolabial Fold
Source: ClinicalTrials.gov NCT02918721 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Treatment Difference in Pain (Restylane Lidocaine Side - Restylane Side) as Measured by a Visual Analogue Scale(VAS) — 77.1 percentage of subjects
Summary
The purpose of this study is to evaluate the pain and safety associated with injections of Restylane Lidocaine compared to Restylane using a visual analogue scale.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Difference in Pain (Restylane Lidocaine Side - Restylane Side) as Measured by a Visual Analogue Scale(VAS) |
77.1 | — |
| SECONDARY Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) |
55.7; 48.6; 35.7; 31.4 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Men or women aged 18 years or older of Chinese origin
- Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study
- Intent to undergo correction of both nasolabial folds(NLF) with a wrinkle severity in Wrinkle Severity Rating Scale(WSRS) of either 3 on both sides or 4 on both sides
Exclusion Criteria
- Previous use of any permanent (non-biodegradable) or semi-permanent facial tissue augmentation therapy or autologous fat below the level of the lower orbital rim
- Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment
- Previous tissue revitalisation treatment with laser or light, mesotherapy radiofrequency, chemical peeling or dermabrasion in the midface within 6 months before treatment
- Scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated
- Other condition preventing the subject from entering the study in the Investigator's opinion
Data sourced from ClinicalTrials.gov (NCT02918721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.