Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid

Enrolling by invitation · Not applicable

Conditions studied: Periorbital Wrinkles, Periorbital Area, Under-eyes Dark Circles, Crows Feet

In brief

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.

Key facts

Study ID

NCT07028203

Run by

BTL Industries Ltd.

People needed

30

Starts

2024-11-05

Expected to finish

2025-12-31

Last updated by the study team

2025-06-19

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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