NCT07028203
Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid
Enrolling by Invitation
NAAges 21+InterventionalTreatmentBTL Industries Ltd.
~30 participants
Updated 2025-06-19 on ClinicalTrials.gov
What's tested:Treatment with BTL-785 with the applicator BTL-785-7-11
At a glance
Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Periorbital area improvement assessment
Measured over baseline to 3 months post-treatment
Conditions
Where it's being run
3 sites across 2 statesCalifornia2
Ohio1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Periorbital area improvement assessmentbaseline to 3 months post-treatment
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.