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ENROLLING BY INVITATION
NCT07028203
NA

Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid

Sponsor: BTL Industries Ltd.

View on ClinicalTrials.gov

Summary

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 periorbital area in healthy adult volunteers. The main question it aims to answer is: Whether the BTL-785-7-11 applicator is able to improve the periorbital area post-treatment, as assessed by the analysis of 3D photographs. Participants will complete four treatments and two follow-up visits.

Official title: Evaluation of the Safety and Efficacy of the BTL-785 Device for Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-11-05

Completion Date

2025-12-31

Last Updated

2025-06-19

Healthy Volunteers

Yes

Interventions

DEVICE

Treatment with BTL-785 with the applicator BTL-785-7-11

The treatment administration phase will consist of four (n=4) treatments, delivered 2 -14 days apart. The applicator will be placed outside the orbital rim, on the subject's inferior orbital portion of the orbicularis oculi muscles and lateral canthal edge-temporal area. Therapy time is set to 20 minutes.

Locations (3)

Laser & Skin Surgery Medical Group, Inc.

Sacramento, California, United States

Art of Skin MD

Solana Beach, California, United States

Gentile Facial Plastic and Aesthetic Laser center

Youngstown, Ohio, United States