Study to Evaluate Satisfaction After Treatment With Kysse

Galderma

Status: Completed

Conditions: Lip Augmentation

Treatments: Device: Hyaluronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT03967444

05DF1807

Details and patient eligibility

About

Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent to participate in the study
• Adult women and men who intend to undergo lip augmentation

Exclusion criteria

• Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
• Subjects with a previous implant other than HA in or near the intended treatment site
• Participation in any other clinical study within three (3) months before treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Restylane Kysse

Other group

Description:

Hyaluronic acid

Treatment:

Device: Hyaluronic acid

Device: Hyaluronic acid

Restylane Kysse with other HA

Other group

Description:

Hyaluronic acid

Treatment:

Device: Hyaluronic acid

Device: Hyaluronic acid