Facial Fillers for Cosmetic Enhancement

(HIT-PRF Trial)

Overseen By Kaitlyn Enright

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Erevna Innovations Inc.

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

Disqualifiers: Uncontrolled systemic disease, Facial nerve palsy, Bleeding disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

18 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 "Profile HIT" considers the balance between the midface, nose, lips, and chin to improve a patient's appearance. This trial will assess the effectiveness of the Profile HIT algorithm in treating patients with different profile issues (e.g. nasal deformities, volume loss, chin retrusion).

Eligibility Criteria

This trial is for adults over 18 in good health who want cosmetic improvements. They must agree to the study's procedures, including photos for marketing and education. Pregnant or breastfeeding women, those planning pregnancy, or with neuromuscular diseases, uncontrolled illnesses, facial conditions, allergies to hyaluronic acid, bleeding disorders or recent COVID infection are excluded.

Inclusion Criteria

Participants must be capable and compliant with the protocol's requirements.

I am not pregnant, breastfeeding, or planning to become pregnant or donate eggs soon.

I have signed and agreed to all parts of the consent form, including the use of my photos for education and marketing.

Exclusion Criteria

You have had an allergic reaction or are highly sensitive to any of the components in the study medication or its ingredients.

I have a disease that is not currently under control.

I don't have conditions that worsen with hyaluronic acid.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive soft tissue filler treatments based on the Profile HIT algorithm

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Holistic Individualized Treatment (HIT) approach

Trial Overview The 'Profile HIT' clinical trial tests a holistic approach using Restylane fillers to enhance facial features like the midface, nose, lips and chin. It aims to see if an algorithm can effectively treat various profile issues by considering individual patient characteristics.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Erevna Innovations Inc.

Lead Sponsor

Trials

13

Recruited

340+