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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to using facial fillers for enhancing appearance. It employs Holistic Individualized Treatment (HIT) to balance features such as the midface, nose, lips, and chin. The goal is to assess how effectively this method can improve appearance for individuals with concerns like nasal deformities or volume loss. Those who feel their facial profile is unbalanced and are in good health might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for enhancing facial appearance.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressants, thrombolytics, or anticoagulants, you may not be eligible to participate.

What prior data suggests that the Holistic Individualized Treatment (HIT) approach is safe for cosmetic enhancement?

Research has shown that the Holistic Individualized Treatment (HIT) approach for facial fillers is generally well-tolerated. Although specific safety data from this trial is unavailable, similar treatments have proven safe when performed by trained professionals.

The HIT approach enhances facial appearance by balancing features like the cheeks, nose, lips, and chin. While specific trial data is lacking, the facial fillers used in this method have been employed in many cosmetic procedures and have received FDA approval for other uses, indicating a certain level of safety.

Typically, facial fillers cause mild side effects, such as temporary swelling or bruising at the injection site, with serious side effects being rare. Prospective trial participants should discuss any concerns with the medical team to ensure the approach aligns with their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Holistic Individualized Treatment (HIT) approach for facial fillers is unique because it customizes cosmetic enhancement to each individual's specific needs and facial structure. Unlike standard treatments that use a one-size-fits-all method, HIT focuses on personalizing the experience, potentially leading to more natural and satisfying results. Researchers are excited about this treatment because it could offer more precise and tailored outcomes, improving both the aesthetic results and patient satisfaction compared to traditional filler techniques.

What evidence suggests that the Holistic Individualized Treatment approach is effective for cosmetic enhancement?

Research shows that the Holistic Individualized Treatment (HIT) method, which participants in this trial will receive, can enhance facial appearance. In earlier studies, at least 90% of participants noticed a visible improvement in midface fullness, indicating the treatment's effectiveness. The benefits last up to nine months, and most patients report high satisfaction with the results. This method aims to balance different facial features, such as the midface, nose, lips, and chin, to create better symmetry. Reports of high satisfaction with overall facial appearance further highlight the treatment's effectiveness. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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/PMC9014959/

Individualized Treatment Algorithm Using Hyaluronic Acid ... Investigator assessment of midface fullness using MMVS showed at least 90% of subjects overall being responders (≥1-grade improvement from ...

2. finance.yahoo.com finance.yahoo.com/news/galderma-unveils-final-nine-month-050000581.html

Galderma Unveils Final Nine-Month Data Showing Lasting ... These data reinforce that this treatment regimen can effectively improve facial aesthetic appearance with high patient satisfaction over nine ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11407320/

Turn Your AART into a HIT Using a Complete Range of ... Optimizing outcomes of aesthetic treatments with injectable products usually requires a consideration of the entire face to ensure balance, ...

4. clinicaltrial.be clinicaltrial.be/en/details/265371?per_page=100&only_recruiting=0&only_eligible=0

"Profile HIT" (Holistic Individualized Treatment) - Clini... This trial will assess the effectiveness of the Profile HIT algorithm in treating patients with different profile issues (eg nasal deformities, volume loss, ...

5. galderma.com galderma.com/news/imcas-2023-galderma-share-latest-data-demonstrating-high-aesthetic-improvement-and-patient

IMCAS 2023: Galderma to share latest data demonstrating ... These findings were complemented by high aesthetic improvement, high subject satisfaction with cheek appearance, and improvement in skin quality ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06336785

Kiss and Smile HIT (Holistic Individualized Treatment) The "Holistic Individualized Treatment" (HIT) approach is used to identify treatment priorities, focus areas, and appropriate products for soft tissue filler ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05819502/profile-hit-holistic-individualized-treatment

"Profile HIT" (Holistic Individualized Treatment) The "Holistic Individualized Treatment" (HIT) approach is used to identify treatment priorities, focus areas, and appropriate products for ...

8. galderma.com galderma.com/news/galderma-unveils-final-nine-month-data-medication-driven-weight-loss

Galderma unveils final nine-month data showing lasting ... These data reinforce that this treatment regimen can effectively improve facial aesthetic appearance with high patient satisfaction over nine ...