NCT02636894CompletedNot Applicable
Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek Fold (Radial Smile Lines)
Amanda D. Spear, CCRC0 sites30 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek folds (Radial Smile Lines)
Study Overview
Brief Summary
Filler study for smile lines in cheek folds
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female between 21-65 years of age
- •Willing to comply with study visits and procedures
- •Willingness to refrain form surgical, laser, or injectable treatments in cheek region during study
Exclusion Criteria
- •History of trauma, acne scarring, burns, or other changes to skin in treatment area
- •Use of botulinum toxin in the lateral cheeks/perioral region in past 6 months
- •Use of injectable fillers in the lateral cheeks/perioral within last 2 years
- •History of facelift in the last year
- •History of facial nerve palsy
Arms & Interventions
Restylane Silk
Other
Restylane Silk
Intervention: Restylane Silk (Device)
Outcomes
Primary Outcomes
Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek folds (Radial Smile Lines)
Time Frame: 6 months
Improvement of subjects based on 5 point global aesthetic scale (GAIS)
Secondary Outcomes
No secondary outcomes reported
Investigators
Amanda D. Spear, CCRC
Brian Biesman, MD
Nashville Centre for Laser and Facial Surgery
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