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

Not Applicable

Completed

• Conditions: Midface Volume Deficit
• Interventions: Device: Restylane Volyme

• Registration Number: NCT03289052
• Lead Sponsor: Galderma R&D

Brief Summary

This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Midface Volume Deficit and/or Midface Contour Deficiency.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Study Start: 2017-12-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-07-31
• Results First Submitted: 2020-11-04
• Results First Submitted QC: 2021-02-19
• Results First Posted: 2021-03-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 9 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restylane Volyme	Restylane Volyme	Single injection and optional touch up injection with Restylane Volyme in Midface

Primary Outcome Measures

Name	Time	Method
Percentage of Responders	6 month	Percentage of responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face concurrently, as measured by the blinded evaluator at 6 months after last treatment in Treatment Group, and at 6 months after randomization in Control Group.; MMVS is a Four-Point scale that 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.

Trial Locations

Locations (1)

Q-Med AB; 🇨🇳 Shanghai, China