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

Lip Augmentation Clinical Trial

Official title:

A Prospective Clinical Study to Evaluate Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05342753
• Other study ID #: 05DF2007
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: January 2024
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 28, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lip Augmentation

Intervention

Device:
• Restylane Kysse
Hyaluronic Acid: Injectable gel for lip augmentation and the correction of upper perioral rhytids

Locations

Country	Name	City	State
Taiwan	Galderma Research Site	Taipei
United States	Galderma Research Site	Ardmore	Pennsylvania
United States	Galderma Research Site	Los Angeles	California
United States	Galderma Research Site	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants assessed as at least 1-point improvement from baseline on MLFS	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'	Week 8
Primary	Proportion of participants assessed as at least 1-point improvement from baseline on MLFS	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'	Week 16
Primary	Proportion of participants assessed as at least 1-point improvement from baseline on MLFS	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'	Week 24
Primary	Proportion of participants assessed as at least 1-point improvement from baseline on MLFS	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'	Week 32
Primary	Proportion of participants assessed as at least 1-point improvement from baseline on MLFS	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'	Week 40
Primary	Proportion of participants assessed as at least 1-point improvement from baseline on MLFS	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'	Week 48
Primary	Change from baseline/last injection on MLFS	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.	Weeks 8, 16, 24, 32, 40 and 48
Secondary	Percentage of participants assessed as at least 1-point improvement from baseline on WAS	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'	Weeks 8, 16, 24, 32, 40, and 48
Secondary	Percentage of participants assessed as at least improved on the GAIS	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'.	Weeks 8, 16, 24, 32, 40, and 48