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

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

NCT03097783•Galderma R&D

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Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. Known/previous allergy or hypersensitivity to any injectable HA gel/local anaesthetics, e.g.lidocaine or other amide-type anaesthetics.
•2. Previous surgery or tattoo in the area to be treated
•3. 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.
•4. 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.
•5. 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.
•6. Other condition preventing the subject from entering the study in the Investigator's opinion.

Locations (1)

Q-Med AB

Shanghai, China

Key Dates

Start Date

April 26, 2017

Primary Completion Date

March 23, 2018

Completion Date

September 14, 2018

Last Updated

November 3, 2023

Enrollment

169

ACTUAL participants

Conditions

Midface Volume Deficit

Interventions

Restylane Perlane Lidocaine

DEVICE

Saypha® VOLUME Lidocaine for Midface Augmentation

NCT05386030

Moderate to Severe Midface Volume Deficit

View study

COMPLETEDNA

Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler

NCT04971876

Lips EnhancementNasolabial Fold Correction+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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