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

NCT02689947 | Completed

• 1 other identifier: Restylane Silk for Tear Trough
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

  Primary outcome effectiveness analysis will test for the mean difference in improvement in terms of baseline to Month 6

  baseline to month 6

Study Arms (1)

Restylane Silk

EXPERIMENTAL

open label no placebo control

Device: Restylane Silk

Interventions

Restylane Silk DEVICE

Restylane Silk

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a healthy male or female between 21 and 65 years old
• Tear trough deformity, Hirmand Type-1 and Type-2
• Is voluntarily willing to consent to participate in the study
• 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
• 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.
• Willingness to refrain from other surgical, laser, or injectable treatments in the periorbital region during the entire duration of the study.
• Ability to provide informed consent.

You may not qualify if:

• Marked delineation of the inferior orbital rim in the lateral aspect of the eyelid/orbit
• Use of botulinum toxin in the periorbital region within the past 6 months.
• 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)
• Laser skin resurfacing of the periorbital region within the past one year.
• History of lower eyelid blepharoplasty or periorbital surgery in tear trough region.
• The subject has a coagulation disorder or is currently using anti-coagulation medication
• History of facial nerve palsy.
• Inability to discontinue the use of nonsteroidal anti-inflammatory drugs or anticoagulants prior to treatment.
• Current participation in another active clinical trial protocol
• Presence of malar festoons
• Active cutaneous infections
• Allergy or sensitivity to benzocaine, lidocaine, prilocaine, or tetracaine.
• Pregnant or nursing females
• Other factors as deemed by the Principal Investigator that would make a subject unqualified for participation.
• The subject has a history of keloids or compromised wound healing

Sponsors & Collaborators

• Nashville Centre for Laser and Facial Surgery: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 24, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03