N/A
N=22
Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects
Lip Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT05342753 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS) — 94.7; 94.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane Kysse (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS) |
94.7; 94.7 | — |
| PRIMARY Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS |
86.7; 86.7 | — |
| PRIMARY Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS |
86.7; 86.7 | — |
| PRIMARY Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS |
86.7; 86.7 | — |
| PRIMARY Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS |
86.7; 86.7 | — |
| PRIMARY Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS |
86.7; 86.7 | — |
| PRIMARY Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection |
1; 10; 7; 1; 1; 8 | — |
| PRIMARY Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection |
1; 7; 8; 1; 1; 6 | — |
| PRIMARY Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection |
1; 6; 6; 1; 1; 6 | — |
| PRIMARY Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection |
2; 9; 4; 1; 2; 8 | — |
| PRIMARY Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection |
2; 8; 4; 1; 2; 7 | — |
| PRIMARY Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection |
2; 9; 4; 0; 2; 9 | — |
| SECONDARY Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS) |
100; 100; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY 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 |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
Summary
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.
Eligibility Criteria
Inclusion Criteria
- 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
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
Data sourced from ClinicalTrials.gov (NCT05342753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.