Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek Fold (Radial Smile Lines)

Not Applicable

Completed

• Conditions: Smile Lines
• Interventions: Device: Restylane Silk

• Registration Number: NCT02636894
• Lead Sponsor: Amanda D. Spear, CCRC

Brief Summary

Filler study for smile lines in cheek folds

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-17
• Study First Posted: 2015-12-22
• Study Start: 2016-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Restylane Silk	Restylane Silk	Restylane Silk

Primary Outcome Measures

Name	Time	Method
Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek folds (Radial Smile Lines)	6 months	Improvement of subjects based on 5 point global aesthetic scale (GAIS)