New Dermal Filler for Lip Augmentation

Galderma

Status: Completed

Conditions: Lip Augmentation

Treatments: Device: Device: FDA Approved Dermal Filler; Device: New Dermal Filler

Study type: Interventional

Funder types: Industry

Identifiers

NCT03320824

43USK1701

Details and patient eligibility

About

To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation

Enrollment: 273 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

273 participants in 2 patient groups

New Dermal Filler

Experimental group

Description:

hyaluronic acid

Treatment:

Device: New Dermal Filler

Dermal Filler

Active Comparator group

Description:

hyaluronic acid

Treatment:

Device: Device: FDA Approved Dermal Filler