Restylane Kysse for Lip Filler

Recruiting at 3 trial locations

Overseen By Clinical Project Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Q-Med AB

Disqualifiers: Allergy to HA, Facial surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Study Director

Principal Investigator

Galderma R&D

Eligibility Criteria

This trial is for adults over 22, of full Chinese descent, who want lip augmentation and can understand English. They must be willing to follow the study rules and not be pregnant or breastfeeding. People with allergies to hyaluronic acid or certain proteins, recent facial procedures, permanent facial treatments, or those in another study within the last month cannot join.

Inclusion Criteria

Ability to adequately understand the verbal explanations and the written subject information provided in English

I am 22 or older, not pregnant or breastfeeding, and both my parents are fully Chinese.

Subjects willing to comply with the requirements of the study and providing a signed written informed consent

Exclusion Criteria

I have had surgery, piercings, tattoos, or trauma to my lips or face.

I had facial surgery below my eyes less than 6 months ago.

Participation in any interventional clinical study within 30 days of screening

Treatment Details

Interventions

• Restylane Kysse

Trial Overview The trial is testing Restylane Kysse's ability to enhance lip appearance in an open-label phase IV study. This means everyone knows they're getting this specific lip filler and its effects on aesthetics are being closely monitored post-marketing.

Participant Groups

Group I: Restylane Kysse Experimental Treatment 1 Intervention

Hyaluronic Acid

Who Is Running the Clinical Trial?

Q-Med AB

Lead Sponsor

Trials

81

Recruited

12,700+

Doug Caro

Q-Med AB

Chief Executive Officer

Economics degree from Florida State University

Dr. Johan Färnstrand

Q-Med AB

Chief Medical Officer

MD from Uppsala University

Galderma R&D

Lead Sponsor

Trials

303

Recruited

60,700+

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD