Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects
NCT ID: NCT05342753
Last Updated: 2025-12-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
22 participants
INTERVENTIONAL
2022-06-13
2024-11-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Restylane Kysse
Hyaluronic Acid
Restylane Kysse
Hyaluronic Acid: Injectable gel for lip augmentation and the correction of upper perioral rhytids
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Restylane Kysse
Hyaluronic Acid: Injectable gel for lip augmentation and the correction of upper perioral rhytids
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Galderma R&D
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Galderma R&D
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Galderma Research Site
Los Angeles, California, United States
Galderma Research Site
Vista, California, United States
Galderma Research Site
Ardmore, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
05DF2007
Identifier Type: -
Identifier Source: org_study_id