BTL-785 for Under-eye Dark Circles

Enrolling by invitation at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BTL Industries Ltd.

Must not be taking: Retinol, Isotretinoin, Anticoagulants, others

Disqualifiers: Cancer, Cardiovascular diseases, Diabetes, others

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

Compensation: Varies

Number of Visits: 7

Duration: 2-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BTL-785-7-11, a cosmetic procedure, to determine its effectiveness in improving under-eye dark circles and wrinkles. Participants will receive four treatments and attend two follow-up visits, with results assessed using 3D photographs. The trial targets adults over 21 with visible signs of aging around the eyes, such as bags or wrinkles, seeking cosmetic improvements. Participants should not have had recent facial treatments or surgeries in the eye area. As an unphased trial, this study provides an opportunity to explore a novel cosmetic solution for under-eye concerns.

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use retinol or any medication that causes skin sensitivity 30 days before the trial or during it.

What prior data suggests that the BTL-785-7-11 applicator is safe for improving the periorbital area?

Research has shown that the BTL-785-7 device has been tested for safety and effectiveness. A study on a similar device, the BTL-785X, found it was safe and effective over a 3-month period. This suggests that treatments with the BTL-785-7 should be well-tolerated. However, the current trial will determine if any side effects occur when used for under-eye dark circles.

Participants will undergo four treatments and attend two follow-up visits to monitor for any reactions. The device is designed for non-surgical facial treatments, but participants should report any discomfort or changes during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

BTL-785 is unique because it uses an innovative applicator, BTL-785-7-11, to target under-eye dark circles. Unlike traditional creams or topical treatments that can take time to show results, this device-based approach promises a more direct and potentially faster effect by delivering treatment to the affected area more precisely. Researchers are excited about BTL-785 because it offers a novel, non-invasive option that could enhance the appearance of under-eye circles with minimal downtime, addressing a common cosmetic concern more efficiently.

What evidence suggests that the BTL-785-7-11 applicator is effective for improving under-eye dark circles?

Research has shown that the BTL-785-7-11 applicator, which participants in this trial will receive, might help reduce under-eye dark circles. In one study, a similar under-eye serum reduced dark skin patches by nearly 48% on average, with no reported side effects. Although this specific applicator is still under testing, it is designed to improve the skin around the eyes. Current findings suggest it could be a promising non-invasive option for those concerned about dark circles. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults who want to improve the appearance of their periorbital area, including crow's feet and under-eye dark circles. Participants will undergo four treatments with follow-up visits.

Inclusion Criteria

I am over 21 and want to improve my eye area's appearance.

Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form

Presence of clearly visible aging signs in the periorbital area (e.g. under-eye bags, periorbital wrinkles) when the face is relaxed as deemed appropriate by the Investigator

Exclusion Criteria

My lower eyelid is not in its normal position.

Metal implants near treatment area or neutral electrode

Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive four treatments with the BTL-785 device for periorbital area rejuvenation

2-8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with 2D and 3D photographs taken and satisfaction questionnaires collected

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BTL-785-7-11

Trial Overview The trial tests the BTL-785-7-11 applicator's effectiveness in rejuvenating the eye area. The main measure of success is improvement in the periorbital region as seen in 3D photographs post-treatment.

How Is the Trial Designed?

Group I: Treatment with BTL-785 with the applicator BTL-785-7-11 Experimental Treatment 1 Intervention

The treatment administration phase will consist of four treatment visits.

Who Is Running the Clinical Trial?

BTL Industries Ltd.

Lead Sponsor

Trials

59

Recruited

2,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07028203

Non-invasive Rejuvenation of the Periorbital Area and ... The goal of this clinical trial is to determine the BTL-785-7-11 applicator effectiveness for an under-eye appearance improvement by evaluation of the ...

2. withpower.com withpower.com/trial/phase-peri-orbital-wrinkles-10-2024-097ef

BTL-785 for Under-eye Dark Circles · Info for Participants The goal of this clinical trial is to determine the BTL-785-7-11 applicator effectiveness for an under-eye appearance improvement by evaluation of the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12235579/

Clinical Efficacy of a Novel Topical Formulation on ... The twice daily use of the under‐eye serum resulted in an average overall reduction in under‐eye hyperpigmentation of 47.94%, with no adverse ...

4. researchgate.net researchgate.net/publication/389767563_The_First_Systematic_Review_and_Meta-Analysis_of_Pharmacological_and_Nonpharmacological_Procedural_Treatments_of_Dark_Eye_Circles_Periorbital_Hyperpigmentations_One_of_the_Most_Common_Cosmetic_Concern

One of the Most Common Cosmetic Concerns Meta-analysis of quartile clinical improvement rates in various periorbital hyperpigmentation treatments based on treatment ...

5. rsdjournal.org rsdjournal.org/rsd/citationstylelanguage/get/acm-sig-proceedings?submissionId=38182&publicationId=39311&issueId=105

Untitled The effects of chemical peelings in the treatment of periorbital hyperpigmentation (dark circles): a literature review. Research, Society and Development.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K222556.pdf

K222556 - David Chmel - accessdata.fda.gov Based on 3-month follow-ups, the treatment with the BTL-785X device equipped with applicator BTL-. 785-7 has shown to be both safe and effective ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04447963

Evaluation of Safety and Efficacy of the BTL-785F Device ... This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-2 applicator for non-invasive treatment of facial ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K211639.pdf

BTL Industries Inc. March 7, 2022 David Chmel VP of ... Page 5 of 11. BTL-785-7 applicator non-clinical performance data. The new BTL-785-7 applicator was tested to achieve superficial skin ...

9. ctv.veeva.com ctv.veeva.com/study/safety-and-efficacy-of-the-btl-785f-device-for-non-invasive-reduction-of-submental-fat

Safety and Efficacy of the BTL-785F Device for Non-invasive ... This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive ...