Pain and Safety of Restylane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds

NCT02918721 | Completed Results

• 1 other identifier: 43CH1504
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasolabial Fold

Keywords

Hyaluronic Acid, Nasolabial Fold, Lidocaine

Outcome Measures

Primary Outcomes (1)

• Treatment Difference in Pain (Restylane Lidocaine Side - Restylane Side) as Measured by a Visual Analogue Scale(VAS)

  Subjects that reported at least 10 mm less VAS pain associated with injections of Restylane-Lido compared to Restylane at the time of injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the participant's VAS mark is measured with a standard ruler.

  Up to 60 minutes after Injection on Day of Treatment

Secondary Outcomes (1)

• Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)

  15, 30, 45, and 60 minutes after injection

Study Arms (2)

Restylane Lidocaine

EXPERIMENTAL

Restylane Lidocaine will be injected into one side nasolabial fold on Day 1

Device: Restylane Lidocaine

Restylane

ACTIVE COMPARATOR

Restylane will be injected into the opposite side nasolabial fold on Day 1

Device: Restylane

Interventions

Restylane Lidocaine DEVICE

Intradermal injection

Restylane Lidocaine

Restylane DEVICE

Intradermal injection

Restylane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Q-Med AB

Shanghai, China

Location

Results Point of Contact

• Title: Head of Development
• Organization: Q-Med AB

reception.seupp@galderma.com

+46184749000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 29, 2016
• Study Start: February 8, 2017
• Primary Completion: April 27, 2017
• Study Completion: May 11, 2017
• Last Updated: June 1, 2023
• Results First Posted: January 6, 2021

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)