Back to resultsEvaluation of the Efficacy of Restylane Silk in the Correction of Tear Trough Deformity
Primary Purpose
Tear Trough Deformity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Restylane Silk
Sponsored by
About this trial
This is an interventional treatment trial for Tear Trough Deformity
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- The subject has a known adverse reaction to previous injection with hyaluronic acid or other subcutaneously injected device
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Restylane Silk
Arm Description
open label no placebo control
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02689947
First Posted
February 4, 2016
Last Updated
March 27, 2018
Sponsor
Nashville Centre for Laser and Facial Surgery
1. Study Identification
Unique Protocol Identification Number
NCT02689947
Brief Title
Evaluation of the Efficacy of Restylane Silk in the Correction of Tear Trough Deformity
Official Title
Evaluation of the Efficacy of Restylane Silk in the Correction of Tear Trough Deformity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nashville Centre for Laser and Facial Surgery
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective single center study to evaluate the safety and effectiveness of Restylane Silk for treatment of tear trough correction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tear Trough Deformity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Restylane Silk
Arm Type
Experimental
Arm Description
open label no placebo control
Intervention Type
Device
Intervention Name(s)
Restylane Silk
Primary Outcome Measure Information:
Title
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
Description
Primary outcome effectiveness analysis will test for the mean difference in improvement in terms of baseline to Month 6
Time Frame
baseline to month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
The subject has a known adverse reaction to previous injection with hyaluronic acid or other subcutaneously injected device
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy of Restylane Silk in the Correction of Tear Trough Deformity
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