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

March 25, 2019 updated by: Amanda D. Spear, CCRC
Filler study for smile lines in cheek folds

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:

  • 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

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
Other: Restylane Silk
Device: Restylane Silk

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Amanda D. Spear, CCRC

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

March 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

December 17, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Actual)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Restylane Silk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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