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

NCT ID: NCT02636894

Last Updated: 2019-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-08-31

Brief Summary

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Filler study for smile lines in cheek folds

Detailed Description

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Conditions

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Smile Lines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Restylane Silk

Restylane Silk

Group Type OTHER

Restylane Silk

Intervention Type DEVICE

Interventions

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Restylane Silk

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amanda D. Spear, CCRC

OTHER

Sponsor Role lead

Responsible Party

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Amanda D. Spear, CCRC

Brian Biesman, MD

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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Restylane Silk

Identifier Type: -

Identifier Source: org_study_id

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