Study to Evaluate Satisfaction After Treatment With Kysse

Not Applicable

Completed

• Conditions: Lip Augmentation
• Interventions: Device: Hyaluronic acid

• Registration Number: NCT03967444
• Lead Sponsor: Galderma R&D

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-27
• Study Start: 2019-05-29
• Study First Posted: 2019-05-30
• Primary Completion: 2019-09-18
• Study Completion: 2019-09-18
• Results First Submitted: 2020-10-08
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-09
• Results First Posted: 2021-03-01
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Signed and dated informed consent to participate in the study
• Adult women and men who intend to undergo lip augmentation

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restylane Kysse with other HA	Hyaluronic acid	Hyaluronic acid
Restylane Kysse	Hyaluronic acid	Hyaluronic acid

Primary Outcome Measures

Name	Time	Method
Assess Treatment With Restylane Kysse Using GAIS	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.

Trial Locations

Locations (1)

Galderma Study Site; 🇨🇦 Toronto, Canada