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

NCT05342753 | Completed Results FDA Device

• 1 other identifier: 05DF2007
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Lip Augmentation

Outcome Measures

Primary Outcomes (12)

• Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS)

  The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.

  At Week 8

• Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS

  The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.

  At Week 16

• Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS

  The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.

  At Week 24

• Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS

  The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.

  At Week 32

• Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS

  The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.

  At Week 40

• Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS

  The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.

  At Week 48

• Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection

  The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.

  8 weeks after last injection (up to 12 weeks)

• Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection

  The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.

  16 weeks after last injection (up to 20 weeks)

• Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection

  The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.

  24 weeks after last injection (up to 28 weeks)

• Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection

  The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.

  32 weeks after last injection (up to 36 weeks)

• Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection

  The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.

  40 weeks after last injection (up to 44 weeks)

• Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection

  The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.

  48 weeks after last injection (up to 52 weeks)

Secondary Outcomes (2)

• Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)

  At Weeks 8, 16, 24, 32, 40, and 48

• Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Weeks 8, 16, 24, 32, 40, and 48

  At Weeks 8, 16, 24, 32, 40, and 48

Study Arms (1)

Restylane Kysse

EXPERIMENTAL

Hyaluronic Acid

Device: Restylane Kysse

Interventions

Restylane Kysse DEVICE

Hyaluronic Acid: Injectable gel for lip augmentation and the correction of upper perioral rhytids

Restylane Kysse

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

Galderma Research Site

Los Angeles, California, 94538, United States

Location

Galderma Research Site

Vista, California, 92083, United States

Location

Galderma Research Site

Ardmore, Pennsylvania, 19003, United States

Location

Results Point of Contact

• Title: Sponsor
• Organization: Galderma Research & Development, LLC

aestheticclinicaltrials@galderma.com

8179615000

Study Officials

• Study Director

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 25, 2022
• Study Start: June 13, 2022
• Primary Completion: October 25, 2024
• Study Completion: November 7, 2024
• Last Updated: December 22, 2025
• Results First Posted: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)