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Completed

NCT Number: NCT03174132

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

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

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Key information

Conditions

Nasolabial Fold

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University, Kaohsiung City, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restylane Perlane Lidocaine

Device

Intradermal injection

Restylane Perlane

Device

Intradermal injection

Primary outcomes

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

    Time frame: At the time of injection

    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.

Secondary outcomes

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

    Time frame: 15, 30, 45, and 60 minutes after injection

    Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane at 15, 30, 45 and 60 minutes after 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Randomised, Multi-center, Subject and Evaluator-blinded Study Comparing the Pain and the Safety Profile Associate With Correction of Moderate to Severe Nasolabial Folds Using Restylane Perlane Lidocaine Compared to Restylane Perlane

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 2, 2017
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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