Restylane Kysse for Lip Filler

No longer 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: 8

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well Restylane Kysse, a lip filler made from hyaluronic acid, improves the appearance of lips in individuals of full Chinese descent. Participants interested in lip augmentation may be suitable candidates. Eligible individuals must be adults with both parents of Chinese descent and an interest in enhancing their lips. Those who have undergone facial surgery or received certain facial fillers in the past year may not qualify. As an unphased trial, this study offers participants the chance to contribute to research that could expand cosmetic options for individuals of Chinese descent.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Restylane Kysse?

Research has shown that Restylane Kysse is generally safe for lip enhancement. Studies have found no major safety issues with its use. Most side effects are mild, such as swelling or redness at the injection site, and these usually resolve quickly.

However, the safety of Restylane Kysse during pregnancy, while planning to become pregnant, or while breastfeeding remains unknown. Additionally, studies have not confirmed its safety for use in areas other than the lips and nearby skin lines.

Overall, evidence suggests that Restylane Kysse is well-tolerated for its approved use in enhancing the lips. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Restylane Kysse is unique because it features a specialized form of hyaluronic acid designed specifically for lip enhancement. Unlike other lip fillers, Restylane Kysse uses XpresHAn Technology™, which allows the filler to integrate more naturally into the tissue, offering a softer and more flexible feel. This not only enhances the natural movement of the lips but also provides longer-lasting results with potentially fewer injections compared to traditional fillers. Researchers are excited about Restylane Kysse because it promises a natural look and feel, while also extending the durability of the lip enhancement.

What is the effectiveness track record for Restylane Kysse as a lip filler?

Research has shown that Restylane Kysse, the treatment under study in this trial, effectively enhances lip fullness. In one study, 98% of participants were satisfied with the feel of their lips after treatment. Another study found an immediate increase in lip size following the procedure. After 12 months, about 25% of participants still noticed fuller lips, and over 39% observed a clear improvement even after a year. These findings suggest that Restylane Kysse can provide long-lasting and natural-looking results for lip enhancement. ^{5 6 7 8 9}

Who Is on the Research Team?

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

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

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?

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

Citations

1.

restylaneusa.com

restylaneusa.com/treatment-area/lips

Discover Before and After Lip Enhancement Results

98%. of subjects were satisfied with the Kysse-ability of their lips. · 96%. of patients agreed that their results looked natural after treatment with Restylane ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11210068/

Comparison of 2 Fillers for Lip Injection—A Randomized- ...

Intragroup analysis revealed a significant increase in lip volume immediately after treatment in the RE group (P = .001; from 17.74 mm ± 2.78 to 20.56 mm ± 3.06) ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5821480/

Randomized, Evaluator-Blinded Study Comparing Safety ...

At 12 months after treatment, approximately 25% of subjects in both groups still had lip fullness improvement, and ≥39% of subjects were improved according to ...

4.

restylaneusa.com

restylaneusa.com/product/restylane-kysse

Get Full Natural-Looking Lips With Restylane® Kysse

Real people. Real results. · 98%. of study participants were satisfied with the Kysse-ability of their lips. · 9 in 10. patients' partners agreed their lips were ...

5.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf14/P140029S021C.pdf

Restylane® Kysse

the safety and effectiveness of Restylane® Kysse versus control for lip augmentation and correction of perioral rhytids. Treatment of the upper perioral ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf14/P140029S021B.pdf

summary of safety and effectiveness data (ssed)

These submitted data provided a reasonable assurance of safety of. Restylane® Kysse for injection into the lips for lip augmentation and the ...

7.

restylaneusa.com

restylaneusa.com/docs/Restylane-Kysse-IFU

Restylane® Kysse

None of the lip assessments were remarkable or presented any safety concerns. Exploratory safety analysis by subgroup (i.e., study site, injection volume, and ...

8.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf14/P140029S021D.pdf

Restylane Kysse

If you are pregnant, trying to become pregnant, or breastfeeding, the safety and effectiveness of Restylane Kysse has not been proven in patients like yourself.

9.

fvpsurgery.com

fvpsurgery.com/content/uploads/2020/06/Restylane-Kysse-Fact-Sheet.pdf

Restylane® Kysse Fact Sheet

The safety or effectiveness of treatment in areas other than lips and upper perioral rhytids has not been established in controlled clinical studies. Restylane ...