Study to Evaluate Satisfaction After Treatment With Restylane
Not Applicable
Completed
- Conditions
- Cheek Augmentation
- Registration Number
- NCT04638816
- Lead Sponsor
- Galderma R&D
- Brief Summary
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
- Signed and dated informed consent to participate in the study
- Adult women who intend to undergo cheek augmentation
Exclusion Criteria
- Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
- Subjects with a previous implant other than HA in or near the intended treatment site
- Participation in any other clinical study within three (3) months before treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS 4 weeks after last treatment, up to 6 weeks The 7-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the treatment area (cheeks) compared to pre-treatment. The rating is very much improved, much improved, improved, no change, worse, much worse, or very much worse.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Galderma Study Site
🇨🇦Montreal, Quebec, Canada
Galderma Study Site🇨🇦Montreal, Quebec, Canada