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

NCT03174132 | Completed Results

• 1 other identifier: 43TW1628
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Nasolabial Fold

Outcome Measures

Primary Outcomes (1)

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

  Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane 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.

  At the time of injection

Secondary Outcomes (1)

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

  15, 30, 45, and 60 minutes after injection

Study Arms (2)

Restylane Perlane Lidocaine

EXPERIMENTAL

Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1

Device: Restylane Perlane Lidocaine

Restylane Perlane

ACTIVE COMPARATOR

Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1

Device: Restylane Perlane

Interventions

Restylane Perlane Lidocaine DEVICE

Intradermal injection

Restylane Perlane Lidocaine

Restylane Perlane DEVICE

Intradermal injection

Restylane Perlane

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

Kaohsiung Medical University

Kaohsiung City, Taiwan

Location

Chang Gung Memorial Hospital

Taipei, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

Results Point of Contact

• Title: Reception
• Organization: Galderma

reception.seupp@galderma.com

+46184749000

Study Officials

• Q-Med AB

  Galderma R&D

  STUDY DIRECTOR

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: May 29, 2017
• First Posted: June 2, 2017
• Study Start: September 21, 2017
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: August 26, 2022
• Results First Posted: September 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)