Status:
COMPLETED
New Dermal Filler for Lip Augmentation
Lead Sponsor:
Galderma R&D
Conditions:
Lip Augmentation
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation
Eligibility Criteria
Inclusion
- Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
- Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
- Seeking augmentation therapy for the lips
Exclusion
- Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins.
- Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents.
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2019
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT03320824
Start Date
November 13 2017
End Date
April 23 2019
Last Update
August 26 2022
Active Locations (14)
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1
Clinical Testing of Bevelry Hills
Encino, California, United States, 91436
2
Cosmetic Laser Dermatology
San Diego, California, United States, 92121
3
Art of Skin MD
Solana Beach, California, United States, 92075
4
Skin Research Institute, LLC
Coral Gables, Florida, United States, 33146