Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects

Not Applicable

Completed

• Conditions: Lip Augmentation

• Registration Number: NCT05342753
• Lead Sponsor: Galderma R&D

Brief Summary

Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-25
• Study Start: 2022-06-13
• Primary Completion: 2024-11-07
• Study Completion: 2024-12-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Subjects willing to comply with the requirements of the study and providing a signed written informed consent
• Ability to adequately understand the verbal explanations and the written subject information provided in English
• Subjects seeking augmentation therapy for the lips
• Adult males or non-pregnant, non-breastfeeding females, 22 years of age or older with both biological parents of full Chinese descent

Exclusion Criteria

• Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
• Previous use of any permanent (non-biodegradable) or semipermanent (e.g., calcium hydroxylapatite or poly-L-lactic acid) facial tissue augmentation therapy, lifting threads, permanent implants or autologous fat below the level of the lower orbital rim.
• Previous use of any HA-based or collagen-based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months prior to the baseline visit.
• Previous facial surgery, within 6 months, below the level of the lower orbital rim
• Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.
• Participation in any interventional clinical study within 30 days of screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline/last injection on MLFS	Weeks 8, 16, 24, 32, 40 and 48	Lip fullness after treatment in the upper and lower lips is evaluated by the Investigator. Lip fullness is quantified with the 5-graded Medicis Lip Fullness Scale (MLFS) with options grade 1 or 'Very Thin', (2) 'Thin', (3) 'Medium', (4) 'Full', and (5) 'Very Full'. Change from baseline after last injection will be calculated for the upper and lower lip separately and presented using descriptive statistics.
Proportion of participants assessed as at least 1-point improvement from baseline on MLFS	Week 48	Lip fullness after treatment in the upper and lower lips is evaluated by the Investigator. Lip fullness is quantified with the 5-graded Medicis Lip Fullness Scale (MLFS) with options grade 1 or 'Very Thin', (2) 'Thin', (3) 'Medium', (4) 'Full', and (5) 'Very Full'

Secondary Outcome Measures

Name	Time	Method
Percentage of participants assessed as at least 1-point improvement from baseline on WAS	Weeks 8, 16, 24, 32, 40, and 48	Aesthetic improvement of the upper perioral rhytids and oral commissures is evaluated by the Investigator. Aesthetic improvement is evaluated with the 6-graded Wrinkle Assessment Scale (WAS) with options grade 0 or 'No wrinkles', (1) 'Just perceptible wrinkle', (2) 'Shallow wrinkles', (3) 'Moderately deep wrinkle', (4) 'Deep wrinkle, well-defined edges', (5) 'Very deep wrinkle, redundant fold'
Percentage of participants assessed as at least improved on the GAIS	Weeks 8, 16, 24, 32, 40, and 48	Aesthetic improvement after treatment in chin and nasolabial fold/marionette line, respectively, and in combination is evaluated by Treating Investigator. Aesthetic improvement is evaluated with the 5-graded Global Aesthetic Improvement Scale (GAIS) with options 'worse', 'no change', 'improved', 'much improved', 'very much improved'.

Trial Locations

Locations (1)

Galderma Research Site; 🇨🇳 Taipei, Taiwan