Revanesse Sculpt+ for Cosmetic Chin Enhancement

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Erevna Innovations Inc.

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

Disqualifiers: Pregnancy, Liver diseases, Heavy smoking, others

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

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new hyaluronic acid gel, Revanesse Sculpt+, designed to improve the appearance of a chin that appears set back from the rest of the face. The goal is to determine if this filler can provide better results with fewer side effects, such as product migration or unwanted bumps. Individuals with noticeable chin retrusion who have not received facial fillers in the lower face in the past year might be suitable candidates. Participants will receive injections and may require a touch-up after two weeks to achieve optimal results.

As an unphased trial, this study offers participants the opportunity to contribute to innovative cosmetic research and potentially enhance their appearance with a new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on blood thinners or certain other medications, you might need to stop them two weeks before treatment. It's best to discuss your specific medications with the trial team.

What prior data suggests that Revanesse Sculpt+ is safe for chin enhancement?

A previous study demonstrated that Revanesse Sculpt+ is safe and well-tolerated for enhancing the chin's appearance. This product is approved for use in Canada and resembles other fillers approved by the FDA for facial treatments. It contains a high amount of hyaluronic acid, a substance naturally found in the body. The product is moderately firm and absorbs little water, which can help prevent side effects like movement from the injection site and changes to nearby skin.

Overall, research has shown that Revanesse Sculpt+ is safe for improving chin appearance. Most participants were satisfied with their results, and side effects were minimal. Studies also suggest that precise injection techniques can lead to better results and fewer risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Revanesse Sculpt+ is unique because it offers a hyaluronic acid-based solution for chin enhancement, which is a relatively new approach compared to traditional surgical options. Unlike chin implants or fillers like Radiesse, Revanesse Sculpt+ provides a non-invasive alternative that can be tailored to each individual's needs based on the aesthetic judgment of the treating physician. Researchers are excited about its potential for more natural-looking results and the convenience of requiring minimal recovery time, making it an appealing option for those looking to enhance their chin profile without surgery.

What is the effectiveness track record for Revanesse Sculpt+ in treating chin retrusion?

Research has shown that hyaluronic acid (HA) fillers can enhance the chin's appearance by improving facial balance and projection. Studies have found that these fillers are generally well-tolerated and effective for individuals with chin retrusion, where the chin appears set back. In this trial, participants will receive Revanesse Sculpt+, a specific HA filler with a high HA content, moderate firmness, and low water absorption. These features help reduce common issues like filler migration or changes in tissue shape. Early research suggests that Revanesse Sculpt+ can effectively improve chin retrusion while minimizing potential side effects. ^{1 2 3 6 7}

Who Is on the Research Team?

Andreas Nikolis, MD, PhD

Principal Investigator

Erevna Innovations Inc.

Are You a Good Fit for This Trial?

This trial is for individuals seeking cosmetic enhancement specifically for chin retrusion, where the chin appears set back in relation to the face. Participants should be looking for non-surgical options and have realistic expectations about the outcomes of HA filler treatments.

Inclusion Criteria

I can understand and agree to the study's procedures and risks.

I agree not to have any other facial procedures during the study.

Participants with established chin retrusion at Baseline based on the Treating Investigator's Allergan Chin Retrusion Scale assessment

Exclusion Criteria

Known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics

Participants without chin retrusion at Screening

Participants with extreme chin retrusion at Screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Revanesse Sculpt+ for chin augmentation at the Baseline visit, with a possible touch-up 2 weeks later

2 weeks

1 visit (in-person) at Baseline, optional touch-up at 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at Months 6 and 12

12 months

Multiple visits (in-person) at Months 6 and 12

What Are the Treatments Tested in This Trial?

Interventions

• Revanesse Sculp+

Trial Overview The trial is testing a new hyaluronic acid gel called Revanesse Sculpt+ designed for chin augmentation. It aims to provide better results with fewer side effects due to its high HA concentration, medium firmness, and low water absorption compared to previous products.

How Is the Trial Designed?

Group I: Revanesse Sculpt+ Experimental Treatment 1 Intervention

Twenty-one (n = 21) male and female participants aged 18 years or older, including seven (n = 7) participants within each of the Allergan Chin Retrusion Scale(ACRS) categories corresponding to mild, moderate, and severe, based on the assessment of the Treating Investigator, will receive Revanesse Sculpt+ for the treatment of mild to severe chin retrusion at the Baseline visit (Visit 2) and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each participant will be determined by the aesthetic judgement of the Treating Investigator.

Who Is Running the Clinical Trial?

Erevna Innovations Inc.

Lead Sponsor

Trials

13

Recruited

340+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07193199

New Technique and Product for Chin Enhancement Their use is well-tolerated and provides satisfactory aesthetic results by improving facial balance and projection. Although the efficacy of ...

2. withpower.com withpower.com/trial/phase-aesthetic-5-2025-dd3e9

Revanesse Sculpt+ for Cosmetic Chin Enhancement This trial is for individuals seeking cosmetic enhancement specifically for chin retrusion, where the chin appears set back in relation to the face.

3. ctv.veeva.com ctv.veeva.com/study/new-technique-and-product-for-chin-enhancement

New Technique and Product for Chin Enhancement Their use is well-tolerated and provides satisfactory aesthetic results by improving facial balance and projection. Although the efficacy of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10980616/

A Randomized, Controlled, Evaluator-Blinded Study - PMC These results demonstrated HA DEF to be effective and safe for the correction of mild-to-moderate chin retrusion in Chinese subjects.

5. ichgcp.net ichgcp.net/amp/clinical-trials-registry/554186-new-technique-and-product-for-chin-enhancement

Chin Augmentation Clinical Trial: Revanesse Sculpt+ Safety and ... Clinical trial investigating the safety and effectiveness of Revanesse Sculpt+ filler for chin augmentation in adults with chin retrusion.

6. revanesse.com revanesse.com/instructions-for-use/

Instructions for Use Revanesse® Versa™+ is an FDA approved hyaluronic acid dermal filler that can be used to treat moderate to severe facial wrinkles and folds, including nasolabial ...

7. sbti.com.br sbti.com.br/wp-content/uploads/2024/11/JDC-08-00275.pdf

Safety and efficacy of female chin enhancement and facial ... This research aimed to assess the effectiveness of a 3-point injection technique using hyaluronic acid (25mg/ml HA reticulated Revanesse Shape G ...