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

Completed · Not applicable

Conditions studied: Lip Augmentation

In brief

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

Key facts

Study ID

NCT05342753

Run by

Galderma R&D

People needed

22

Starts

2022-06-13

Expected to finish

2024-11-07

Last updated by the study team

2025-12-22

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Galderma Research Site — Los Angeles, California, United States
• Galderma Research Site — Vista, California, United States
• Galderma Research Site — Ardmore, Pennsylvania, United States

Full record on ClinicalTrials.gov

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