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

NCT ID: NCT02689947

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-03-31

Brief Summary

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

Conditions

Tear Trough Deformity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Restylane Silk

open label no placebo control

Group Type: EXPERIMENTAL

Restylane Silk

Intervention Type: DEVICE

Interventions

Restylane Silk

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nashville Centre for Laser and Facial Surgery

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Restylane Silk for Tear Trough

Identifier Type: -

Identifier Source: org_study_id