Status:
COMPLETED
Restylane Volyme for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Lead Sponsor:
Galderma R&D
Conditions:
Midface Volume Deficit
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Midface Volume Deficit and/or Midface Contour Deficiency.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT03289052
Start Date
December 1 2017
End Date
July 31 2019
Last Update
May 12 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Q-Med AB
Shanghai, China