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

March 27, 2018 updated by: Nashville Centre for Laser and Facial Surgery
Prospective single center study to evaluate the safety and effectiveness of Restylane Silk for treatment of tear trough correction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Restylane Silk
open label no placebo control
Device: Restylane Silk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: baseline to month 6
Primary outcome effectiveness analysis will test for the mean difference in improvement in terms of baseline to Month 6
baseline to month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nashville Centre for Laser and Facial Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Restylane Silk for Tear Trough

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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