Evaluation of the Efficacy of Restylane Silk in the Correction of Tear Trough Deformity

Not Applicable

Completed

• Conditions: Tear Trough Deformity
• Interventions: Device: Restylane Silk

• Registration Number: NCT02689947
• Lead Sponsor: Nashville Centre for Laser and Facial Surgery

Brief Summary

Prospective single center study to evaluate the safety and effectiveness of Restylane Silk for treatment of tear trough correction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-24
• Study Start: 2016-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

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

Inclusion Criteria

1. Is a healthy male or female between 21 and 65 years old
2. Tear trough deformity, Hirmand Type-1 and Type-2
3. Is voluntarily willing to consent to participate in the study
4. Is willing to comply with all requirements of the study including being photographed, follow post treatment care instructions, to attend all treatment, and follow up visits
5. Willingness to waive rights to use of still photos of themselves for research, marketing, or promotional reasons, including on the internet and on social media outlets.
6. Willingness to refrain from other surgical, laser, or injectable treatments in the periorbital region during the entire duration of the study.
7. Ability to provide informed consent.

Exclusion Criteria

1. Marked delineation of the inferior orbital rim in the lateral aspect of the eyelid/orbit
2. Use of botulinum toxin in the periorbital region within the past 6 months.
3. Treatment with injectable fillers in the midface or periorbital region within the past 2 years or treatment at any time in the past with a permanent filler in the midface or periorbital region such as silicone, or PMMA (Artefill)
4. Laser skin resurfacing of the periorbital region within the past one year.
5. History of lower eyelid blepharoplasty or periorbital surgery in tear trough region.
6. The subject has a coagulation disorder or is currently using anti-coagulation medication
7. History of facial nerve palsy.
8. Inability to discontinue the use of nonsteroidal anti-inflammatory drugs or anticoagulants prior to treatment.
9. Current participation in another active clinical trial protocol
10. Presence of malar festoons
11. Active cutaneous infections
12. Allergy or sensitivity to benzocaine, lidocaine, prilocaine, or tetracaine.
13. Pregnant or nursing females
14. Other factors as deemed by the Principal Investigator that would make a subject unqualified for participation.
15. The subject has a history of keloids or compromised wound healing
16. The subject has a known adverse reaction to previous injection with hyaluronic acid or other subcutaneously injected device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Restylane Silk	Restylane Silk	open label no placebo control

Primary Outcome Measures

Name	Time	Method
Primary outcome effectiveness analysis will test for the mean difference and overall improvement of radial smile lines based on baseline assessment and changes to the 6 month visit	baseline to month 6	Primary outcome effectiveness analysis will test for the mean difference in improvement in terms of baseline to Month 6