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OpenTrials
Completed

NCT Number: NCT04638816

Study to Evaluate Satisfaction After Treatment With Restylane

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

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Key information

Conditions

Cheek Augmentation

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Study Site, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restylane Volyme

Device

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

Restylane Lyft Lidocaine

Device

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

Primary outcomes

  1. Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS

    Time frame: 4 weeks after last treatment, up to 6 weeks

    The 7-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the treatment area (cheeks) compared to pre-treatment. The rating is very much improved, much improved, improved, no change, worse, much worse, or very much worse.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Study Comparing Hyaluronic Acid Effectiveness & Evaluating Cheek Results With Restylane

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2020
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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