Evaluation of the Efficacy of Restylane Silk in the Treat... | NCT02636894

Studies
Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek Fold (Radial Smile Lines)

NCT02636894

Sponsor

Amanda D. Spear, CCRC

Status

Completed

Last Update Posted

Mar 27, 2019Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Smile Lines

Interventions

Restylane Silk

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Dec 16, 2015

First Submission Date that Met QC Criteria

Dec 17, 2015

First Posted Date

Dec 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2019

Last Update Posted Date

Mar 27, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amanda D. Spear, CCRC, Brian Biesman, MD, Nashville Centre for Laser and Facial SurgerySponsor-Investigator

Lead Sponsor

Amanda D. Spear, CCRCOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Restylane Silk	Other	Restylane Silk	Device: Restylane Silk

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Restylane Silk	Device		Restylane Silk

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek folds (Radial Smile Lines)	Improvement of subjects based on 5 point global aesthetic scale (GAIS)	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female between 21-65 years of age
Willing to comply with study visits and procedures
Willingness to refrain form surgical, laser, or injectable treatments in cheek region during study

Exclusion Criteria:

History of trauma, acne scarring, burns, or other changes to skin in treatment area
Use of botulinum toxin in the lateral cheeks/perioral region in past 6 months
Use of injectable fillers in the lateral cheeks/perioral within last 2 years
History of facelift in the last year
History of facial nerve palsy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided