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

NCT03289052 | Completed Results

• 1 other identifier: 43CH1626
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Midface Volume Deficit

Keywords

Hyaluronic acid, midface

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders

  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.

  6 month

Study Arms (2)

Restylane Volyme

EXPERIMENTAL

Single injection and optional touch up injection with Restylane Volyme in Midface

Device: Restylane Volyme

No intervention arm

NO INTERVENTION

No treatment

Interventions

Restylane Volyme DEVICE

Subcutis injection

Restylane Volyme

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 9 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

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: September 18, 2017
• First Posted: September 20, 2017
• Study Start: December 1, 2017
• Primary Completion: January 31, 2019
• Study Completion: July 31, 2019
• Last Updated: May 12, 2023
• Results First Posted: March 15, 2021

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)