50 Participants Needed

Restylane Kysse for Lip Filler

Recruiting at 3 trial locations
CP
Overseen ByClinical Project Manager
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Q-Med AB
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

SD

Study Director

Principal Investigator

Galderma R&D

Are You a Good Fit for This Trial?

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
See 1 more

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
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Restylane Kysse for lip augmentation

48 weeks
Visits at weeks 8, 16, 24, 32, 40, and 48

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Restylane KysseExperimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini profile image

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD

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