Study to Evaluate Satisfaction After Treatment With Kysse

Not Applicable

Completed

• Conditions: Lip Augmentation

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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