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

NCT03097783 | Completed Results

• 1 other identifier: 43CH1507
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Midface Volume Deficit

Keywords

hyaluronic acid, midface

Outcome Measures

Primary Outcomes (1)

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

  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. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence

  6 month

Study Arms (2)

Restylane Perlane Lidocaine

EXPERIMENTAL

Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface

Device: Restylane Perlane Lidocaine

No intervention arm

NO INTERVENTION

No treatment

Interventions

Restylane Perlane Lidocaine DEVICE

Intradermal injection

Restylane Perlane Lidocaine

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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Q-Med AB

Shanghai, China

Location

Related Publications (1)

• Wang X, Wu Y, Li B, Mu X, Li L. Lifting the midface using a hyaluronic acid filler with lidocaine: A randomized multi-center study in a Chinese population. J Cosmet Dermatol. 2022 Dec;21(12):6710-6716. doi: 10.1111/jocd.15286. Epub 2022 Oct 25.

  PMID: 35925834 DERIVED

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 31, 2017
• Study Start: April 26, 2017
• Primary Completion: March 23, 2018
• Study Completion: September 14, 2018
• Last Updated: November 3, 2023
• Results First Posted: July 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)