Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid

NCT07028203 | Enrolling By Invitation FDA Device

• 1 other identifier: BTL-785_CTUS1800
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Periorbital Wrinkles; Periorbital Area; Under-eyes Dark Circles; Crows Feet

Keywords

under-eye bags; dark circles; periorbital; crows feet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assessment of changes in the visual appearance, according to the Global Aesthetic Improvement Scale

  baseline to 3 months post-treatment

• Assessment of changes in the visual appearance, according to the Fitzpatrick Wrinkle and Elastosis Scale

  baseline to 3 months post-treatment

• Assessment of changes in the visual appearance, according to the Crow's Feet Grading Scale

  baseline to 3 months post-treatment

• Subject satisfaction as assessed by Subject Satisfaction Questionnaire

  baseline to 3 months post-treatment

• Comfort as assessed by Therapy Comfort Questionnaire

  from the first to the last treatment session, assessed up to 56 days

Study Arms (1)

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

EXPERIMENTAL

The treatment administration phase will consist of four treatment visits.

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (3)

Laser & Skin Surgery Medical Group, Inc.

Sacramento, California, 95816, United States

Location

Art of Skin MD

Solana Beach, California, 92075, United States

Location

Gentile Facial Plastic and Aesthetic Laser center

Youngstown, Ohio, 44512, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 19, 2025
• Study Start: November 5, 2024
• Primary Completion: November 9, 2025
• Study Completion: December 31, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (3)