An interventional study of Treatment with BTL-785 with the applicator BTL-785-7-11 in Periorbital Wrinkles, Periorbital Area and Under-eyes Dark Circles, sponsored by BTL Industries Ltd.. Enrolling by invitation at 3 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
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 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.
BTL Industries Ltd. is the lead sponsor of 77 studies on the registry; 5 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: baseline to 3 months post-treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline to 3 months post-treatment
Started Nov 2024 (actual). Primary completion is estimated for Nov 2025, 12 months after the start.
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