A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Restylane Volyme for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Percentage of Responders
Study Overview
Brief Summary
This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Midface Volume Deficit and/or Midface Contour Deficiency.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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.
Arms & Interventions
No intervention arm
No treatment
Restylane Volyme
Single injection and optional touch up injection with Restylane Volyme in Midface
Intervention: Restylane Volyme (Device)
Outcomes
Primary Outcomes
Percentage of Responders
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported