Fillers and Neuromodulators for Cosmetic Lip Enhancement

No longer recruiting at 1 trial location

Overseen By Kaitlyn Enright, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Erevna Innovations Inc.

Must not be taking: Thrombolytics, Anticoagulants, Immunosuppressants, others

Disqualifiers: Uncontrolled systemic disease, Facial nerve palsy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new approach called "Kiss and Smile HIT" to enhance lips. The goal is to assess how well this method improves lip volume, framing, and expression using treatments like Dysport (a neuromodulator that acts as a muscle relaxer) and Restylane fillers. Individuals with thin lips, poorly defined lip shape, or difficulty smiling confidently might be suitable candidates. Participants should be in good health and willing to have their photos used for marketing and education. As a Phase 4 trial, this research involves treatments that are already FDA-approved and proven effective, aiming to understand how they benefit more patients.

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

The trial information does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressant medication, you cannot participate in the trial.

What is the safety track record for Dysport neuromodulator and Restylane line of dermal fillers?

Research shows that Dysport, a type of muscle relaxer, is generally safe for cosmetic use. Skilled professionals have reported no serious issues when administering it. The most common complaints are minor, such as bruising, redness, or pain at the injection site.

Studies on Restylane, a filler often used for lip enhancement, show similar results. Most side effects are mild and temporary, including swelling, pain, or small bumps. The FDA has approved Restylane for various cosmetic uses, indicating a strong safety record when used correctly.

Past studies have shown that most patients tolerate both treatments well, making them generally safe options for lip enhancement. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard lip enhancement options that typically focus on either volume or shaping, the combination of Dysport neuromodulator and Restylane dermal fillers offers a comprehensive approach. This treatment targets not just lip volume, but also framing and expression, making it versatile for different cosmetic needs. Researchers are excited because it uses hyaluronic acid to provide natural-looking results with the added potential for quicker touch-ups, offering more personalized and lasting enhancements compared to existing treatments.

What evidence suggests that the Kiss and Smile HIT approach is effective for cosmetic lip enhancement?

In this trial, participants will receive both Dysport and Restylane treatments. Research has shown that Dysport works well for cosmetic treatments, particularly in enhancing facial appearance. Users report that the effects last about 3 to 4 months, with approximately 95% expressing satisfaction with the results.

For Restylane fillers, studies have highlighted excellent results in enhancing lips. About 96% of participants felt their lips looked natural after treatment, and there was a 99% success rate in restoring lip volume. Most noticed improvements lasting up to 18 months. Both Dysport and Restylane have strong research support for their effectiveness in cosmetic procedures. ^{2 6 7 8 9}

Who Is on the Research Team?

Andreas Nikolis, MD

Principal Investigator

Erevna Innovations Inc.

Are You a Good Fit for This Trial?

This trial is for individuals seeking cosmetic enhancements specifically for their lips and smile. Ideal candidates are those looking to address issues like volume loss, poorly defined lip contours, or expression-related concerns that affect confidence in their smile.

Inclusion Criteria

Subjects must be willing and able to comply with procedures required in the protocol

Subjects must be in good health as per investigator's judgment based on medical history

I have signed and agreed to all consent forms for the study, including the use of my photos.

Exclusion Criteria

History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study medical device

History of an allergic reaction or significant sensitivity to constituents of the study medical device (or its excipients)

Subject has tattoos, jewelry, or clothing which obscure temporal region and cannot be removed

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active treatment with hyaluronic acid at Baseline, with an optional touch-up at week two

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 months

Visits at Week 4, Week 8, and Week 20

What Are the Treatments Tested in This Trial?

Interventions

• Dysport neuromodulator
• Restylane line of dermal fillers

Trial Overview The trial tests the 'Kiss and Smile HIT' algorithm using Restylane fillers and Dysport neuromodulator. It aims to personalize treatment based on individual facial features, focusing on improving lip volume, framing, and expressive aspects of the smile.

How Is the Trial Designed?

Group I: Restylane Filler Line and Dysport Neuromodulator Experimental Treatment 1 Intervention

This study will consist of an open-label, prospective, cohort trial design. Twenty-four subjects will be recruited. Subjects will be recruited based on their primary deficit, 8 subjects will have a primary deficit in lip volume, 8 subjects will have a primary deficit in lip framing and 8 subjects will have a primary deficit in expression. All subjects will receive active treatment with hyaluronic acid at Baseline, with an optional touch at week two. There will be no placebo or no-treatment control groups. Subjects will be followed for five months.

Who Is Running the Clinical Trial?

Erevna Innovations Inc.

Lead Sponsor

Trials

13

Recruited

340+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10541165/

Office‐based facial plastics procedures: Neuromodulators - PMC , Prior studies comparing Botox and Dysport have reported conflicting results in the difference in effectiveness between the two products. Lowe et al ...

2. plasticsurgery.org plasticsurgery.org/documents/news/statistics/2023/plastic-surgery-statistics-report-2023.pdf

2023 Plastic Surgery Statistics Report Conclusion. Neuromodulator injections continue to be a leader in minimally invasive cosmetic proce- dures due to its effectiveness, ...

3. skinlyaesthetics.com skinlyaesthetics.com/dysport-injections/

Dysport Injections - Benefits, Costs, Results & Procedure ... Efficacy: Dysport has been clinically studied and tested and has proven to be very effective in treating both cosmetic and medical concerns, such as the ...

4. 4estheticslounge.com 4estheticslounge.com/injectables-fillers/xeomin-dysport/

Xeomin Lexington | Dysport Injections | 4esthestics Lounge The effects typically last around 3–4 months based on actual patient data, and many clients choose maintenance appointments to keep results consistent. Because ...

5. drkhorasani.com drkhorasani.com/post/can-starting-botox-treatment-early-prevent-wrinkles

Can Starting Botox/Dysport Treatment Early Prevent ... 3. Botox and Dysport are effective. Neuromodulators have a rare 95% approval rating on the RealSelf website, which polls patients about all types of medically- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3461789/

Complications of Minimally Invasive Cosmetic Procedures The most common complications from BoNT and soft-tissue filler injection are bruising, erythema and pain. With chemical peels, it is not uncommon to have ...

7. dermboston.com dermboston.com/dermatology-services-boston/cosmetic-treatments/neuromodulators/

Neuromodulators Boston | Botox | Dysport Boston It is very safe, as long as the injection is administered by an experienced professional. There have been ZERO serious problems ever reported from the cosmetic ...

8. drkhorasani.com drkhorasani.com/post/when-neuromodulator-injections-lead-to-complications

When Neuromodulator Injections Lead to Complications You likely think of Botox or Dysport as a quick, safe, predictable way to tone down your frown lines and give your eyes a lift.

9. kalosmedicalspa.com kalosmedicalspa.com/are-off-label-procedures-safe/

Are Off-Label Procedures Safe? Neuromodulators such as Botox® and Dysport® are FDA-approved to treat forehead lines, crow's feet, and frown lines between the eyebrows, however ...