Status:
COMPLETED
Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects
Lead Sponsor:
Galderma R&D
Conditions:
Lip Augmentation
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05342753
Start Date
June 13 2022
End Date
November 7 2024
Last Update
December 22 2025
Active Locations (3)
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1
Galderma Research Site
Los Angeles, California, United States, 94538
2
Galderma Research Site
Vista, California, United States, 92083
3
Galderma Research Site
Ardmore, Pennsylvania, United States, 19003