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Completed

NCT Number: NCT03097783

Restylane Perlane Lidocaine for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

This is a randomized, multi-center, evaluator-blinded, no-treatment controlled study to evaluate the efficacy and safety of Restylane Perlane Lidocaine for correction of Midface Volume Deficit and/or Midface Contour Deficiency.

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Key information

Conditions

Midface Volume Deficit

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Q-Med AB

Shanghai, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent
  • Men or women aged 18 years of age 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
  • Subjects seeking augmentation therapy for the midface
  • MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator

Exclusion criteria

  • Known/previous allergy or hypersensitivity to any injectable HA gel/local anaesthetics, e.g.lidocaine or other amide-type anaesthetics.
  • Previous surgery or tattoo in the area to be treated
  • 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 or neurotoxin within 12 months before treatment.
  • Scars or deformities, active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema, rosacea, acne psoriasis and herpes zoster 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

Primary outcomes

  1. Percent Responders With 1 Point Improvement on the Medicis Midface Volume Scale

    Time frame: 6 month

    The primary objective is to demonstrate superiority of Perlane-Lido relative to no-treatment in the treatment of Midface volume Deficit and/or Midface Contour Deficiency by comparing the percent responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face, as measured by blinded evaluator at 6 months.

    Medicis Midface Volume Scale (MMVS) is a 4-grade scale assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator will rate the subject's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits.

    • Fairly full midface
    • Mild loss of fullness in midface area
    • Moderate loss of fullness with slight hollowing below malar prominence
    • Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Efficacy and Safety of Restylane Perlane Lidocaine for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 31, 2017
Registry last updated
Nov 3, 2023

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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