N/A
Completed N=70
Pain and Safety of Restylane Perlane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds
Nasolabial Fold
Source: ClinicalTrials.gov NCT03174132 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) — 87.1 percentage of subjects
Summary
The purpose of this study is to evaluate the pain and safety in associated with injection of Restylane Perlane Lidocaine compared to Restylane Perlane using VAS scale
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) |
64.3; 42.9; 31.4; 24.3 | — |
| SECONDARY Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) |
64.3; 42.9; 31.4; 24.3 | — |
Eligibility Criteria
Inclusion Criteria
- Signed and dated informed consent to participate in the study.
- Men or women aged 20 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 grade 3 on both NLFs or grade 4 on both NLFs.
Exclusion Criteria
- Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant 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 revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, 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 (NCT03174132). 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.