Study to Evaluate Satisfaction After Treatment With Kysse

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

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Key information

Conditions

Lip Augmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Study Site, Montreal, Canada

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 and men who intend to undergo lip 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

Hyaluronic Acid

Device

Injectable gel for lip augmentation

Other names: Restylane Kysse

Primary outcomes

Assess Treatment With Restylane Kysse Using GAIS

Time frame: 8 weeks after last treatment

The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

Post Marketing Study to Evaluate Lip Augmentation & Satisfaction With Restylane Kysse

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: May 30, 2019
Registry last updated: Aug 26, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed