Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects (NCT05342753) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects
United States22 participantsStarted 2022-06-13
Plain-language summary
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS)
Timeframe: At Week 8
2
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Timeframe: At Week 16
3
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Timeframe: At Week 24
4
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Timeframe: At Week 32
5
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Timeframe: At Week 40
6
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Timeframe: At Week 48
7
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection