Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Periorbital Wrinkles; Under-eyes Dark Circles; Crows Feet; Periorbital Area
• Intervention / Treatment: Device: Treatment with BTL-785 with the applicator BTL-785-7-11

Detailed Description

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 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. At the last therapy visit, the subject's digital 2D and 3D photographs of the treatment area will be collected. In addition, subjects will receive therapy comfort and subject satisfaction questionnaires to fill in.

During the 1-month and 3-month follow-up visits, the subjects will undergo 2D and 3D photographing of the treatment area, and the subject satisfaction questionnaires will be collected.

Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all follow-up visits.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Laser & Skin Surgery Medical Group, Inc.
    • Solana Beach, California, United States, 92075
      • Art of Skin MD
  • Ohio
    • Youngstown, Ohio, United States, 44512
      • Gentile Facial Plastic and Aesthetic Laser center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 participation
• Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken

Exclusion Criteria:

• Lower eyelid malposition (ectropion, entropion, retraction)
• Blepharitis
• Prior lower eyelid fat removal, skin resection, eyelid surgery or orbital trauma in the past 6 months, prior dermatochalasis of lower eyelids surgical treatment in the past 6 months
• Filler injections in the treatment area and midface region within 3 months prior to the study participation
• Neuromodulator treatment in the periorbital area within 3 months prior to the study participation
• Tattoo(s) and/or permanent make-up in the intended treatment area
• Prior usage within 30 days before the screening or planned usage during the study of retinol, or any medication that can cause dermal hypersensitivity
• Bacterial or viral infection, acute inflammations
• Impaired immune system
• Isotretinoin in the past 12 months
• Skin-related autoimmune diseases
• Radiation therapy and chemotherapy
• Poor healing and unhealed wounds in the treatment area
• Metal implants near treatment area or neutral electrode
• Permanent implant near the area to be treated
• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
• Current condition or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
• History of any type of malignant cancer
• Active collagen diseases
• Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
• Pregnancy/nursing or IVF procedure
• History of bleeding coagulopathies, use of anticoagulants
• Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
• Any surgical procedure in the treatment area within the last three months or before complete healing
• Poorly controlled endocrine disorders, such as diabetes
• Electroanalgesia without exact diagnosis of pain etiology
• Tuberculosis
• Hepatitis
• Febrile conditions
• Acute neuralgia and neuropathy
• Kidney or liver failure
• Sensitive disorders in the treatment area
• Varicose veins, pronounced edemas
• Skin dermabrasion, skin resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
• Application in the area of chest, heart, carotid sinus, mouth (i.e. over the lips and in the near proximity) or over the eyes (i.e. over the eyeballs and eyelids)
• Serious psychopathological disorders (such as schizophrenia)
• Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
• Blood vessels and lymphatic vessels inflammation
• Scarring in the treatment area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with BTL-785 with the applicator BTL-785-7-11; The treatment administration phase will consist of four treatment visits.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periorbital area improvement assessment	The evaluation of the periorbital area improvement comparing pre-treatment, the last therapy visit, and both 1-month and 3-month follow-up visits will be based on the analysis of 3D photographs.	baseline to 3 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of changes in the visual appearance, according to the Global Aesthetic Improvement Scale	The assessment of changes in the visual appearance will be based on the evaluation of the 2D photographs, according to the Global Aesthetic Improvement Scale (GAIS); the ranking is based on the 5-point scale (ranging from -1 to 3), higher score means a more improved appearance.	baseline to 3 months post-treatment
Assessment of changes in the visual appearance, according to the Fitzpatrick Wrinkle and Elastosis Scale	The assessment of changes in the visual appearance will be based on the evaluation of the 2D photographs, according to the Fitzpatrick Wrinkle and Elastosis Scale (FWES); the ranking is based on the 10-point scale (ranging from 0 to 9), higher score means a more severe aesthetic condition being evaluated.	baseline to 3 months post-treatment
Assessment of changes in the visual appearance, according to the Crow's Feet Grading Scale	The assessment of changes in the visual appearance will be based on the evaluation of the 2D photographs, according to the Crow's Feet Grading Scale (CFGS); the ranking is based on the 5-point scale (ranging from 0 to 4), higher score means a more severe crow's feet.	baseline to 3 months post-treatment
Subject satisfaction as assessed by Subject Satisfaction Questionnaire	Subject Satisfaction evaluation based on the Subject Satisfaction Questionnaire; the ranking is based on the 5-point Likert scale (1-5), higher score means higher satisfaction.	baseline to 3 months post-treatment
Comfort as assessed by Therapy Comfort Questionnaire	Therapy comfort evaluation through the Therapy Comfort Questionnaire; the ranking is based on the 5-point Likert scale (1-5), higher score means higher comfort, and on the Numerical Analog scale (0-10), higher score means higher pain.	from the first to the last treatment session, assessed up to 56 days
Incidence of Treatment-related Adverse Events	Assessment of safety by evaluating the side effects and AE occurrence throughout the study.	baseline to 3 months post-treatment

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Estimated): November 9, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 9, 2025
• First Submitted That Met QC Criteria: June 17, 2025
• First Posted (Actual): June 19, 2025

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: periorbital; dark circles; under-eye bags; crows feet
• Other Study ID Numbers: BTL-785_CTUS1800

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No