Study to Evaluate Satisfaction After Treatment With Restylane

NCT ID: NCT04638816

Last Updated: 2024-03-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-16

Study Completion Date

2021-08-20

Brief Summary

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Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane

Detailed Description

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Conditions

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Cheek Augmentation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Restylane Volyme

Hyaluronic Acid

Group Type EXPERIMENTAL

Restylane Volyme

Intervention Type DEVICE

Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).

Restylane Lyft Lidocaine

Hyaluronic Acid

Group Type EXPERIMENTAL

Restylane Lyft Lidocaine

Intervention Type DEVICE

Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).

Interventions

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Restylane Volyme

Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).

Intervention Type DEVICE

Restylane Lyft Lidocaine

Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Signed and dated informed consent to participate in the study
* Adult women who intend to undergo cheek augmentation

Exclusion Criteria

* Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
* Subjects with a previous implant other than HA in or near the intended treatment site
* Participation in any other clinical study within three (3) months before treatment
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Galderma R&D

Locations

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Galderma Study Site

Vancouver, British Columbia, Canada

Site Status

Galderma Study Site

Woodbridge, Ontario, Canada

Site Status

Galderma Study Site

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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05DF2004

Identifier Type: -

Identifier Source: org_study_id

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