NCT02636894

Brief Summary

Filler study for smile lines in cheek folds

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

December 16, 2015

Last Update Submit

March 25, 2019

Conditions

Smile Lines

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Restylane Silk

OTHER

Restylane Silk

Device: Restylane Silk

Interventions

Restylane SilkDEVICE
Restylane Silk

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Brian Biesman, MD

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 22, 2015

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 27, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share