Fillers and Neuromodulators for Cosmetic Lip Enhancement

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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

The "Holistic Individualized Treatment" (HIT) approach is used to identify treatment priorities, focus areas, and appropriate products for soft tissue filler treatments. The "Kiss and Smile HIT" considers lip volume, lip framing and expression to improve patients appearance. This trial will assess the effectiveness of the Kiss and Smile HIT algorithm in treating patients with different kiss and smile related issues (e.g. volume loss, lips lack proper framing, lack of a confident smile due to issues with expression).

Research Team

Andreas Nikolis, MD

Principal Investigator

Erevna Innovations Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+