BTL Industries Ltd.
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.
The study will evaluate the clinical efficacy and safety of the BTL-785 device with applicator BTL-785-7-11 for periorbital area rejuvenation. The study has a prospective, multicenter, open-label, and one-arm design. Subjects will be required to complete four (n=4) treatment visits and two (n=2) follow-up visits. At the baseline visit, inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient. Digital 2D and 3D photographs of the treatment area will be taken. The treatment administration phase will consist of four (n=4) treatments, delivered 2 -14 d…
Inclusion Criteria: * Healthy male or female subjects over 21 years of age seeking aesthetic improvement of the periorbital area * 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 * Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study partici…
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.
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