Periorbital WrinklesNCT07028203
Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid
A study testing Treatment with BTL-785 with the applicator BTL-785-7-11 in people with Periorbital Wrinkles and Periorbital Area, run by BTL Industries Ltd. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periorbital Wrinkles, Periorbital Area, Under-eyes Dark Circles
- What is being tested?
- Treatment with BTL-785 with the applicator BTL-785-7-11
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 39Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Laser & Skin Surgery Medical Group, Inc.
Sacramento, California, 95816
Art of Skin MD
Solana Beach, California, 92075
Gentile Facial Plastic and Aesthetic Laser center
Youngstown, Ohio, 44512
About this study
Official title: 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.
Read the 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.
- Being tested
- Treatment with BTL-785 with the applicator BTL-785-7-11
- Keywords
- under-eye bags, dark circles, periorbital, crows feet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with BTL-785 with the applicator BTL-785-7-11Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BTL-785 with the applicator BTL-785-7-11 | Experimental | The treatment administration phase will consist of four treatment visits. Receives: Device: Treatment with BTL-785 with the applicator BTL-785-7-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 3 months post-treatment
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline to 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start5 Nov 2024
- Primary completion9 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periorbital WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028203
- Sponsor's protocol ID
- BTL-785_CTUS1800
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the BTL-785 Device for Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid
- ClinicalTrials.gov ID
- NCT07028203
- Acronym / sponsor ID
- BTL-785_CTUS1800
- Keywords
- under-eye bags, dark circles, periorbital, crows feet
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 9 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with BTL-785 with the applicator BTL-785-7-11 | Experimental | Device: Treatment with BTL-785 with the applicator BTL-785-7-11The treatment administration phase will consist of four treatment visits. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (39 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with BTL-785 with the applicator BTL-785-7-11The 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. | Device | Treatment with BTL-785 with the applicator BTL-785-7-11 |
Primary outcome
Periorbital area improvement assessment
Time frame: baseline 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.
6 secondary outcomes
Assessment of changes in the visual appearance, according to the Global Aesthetic Improvement Scale
Time frame: baseline to 3 months post-treatment
Assessment of changes in the visual appearance, according to the Fitzpatrick Wrinkle and Elastosis Scale
Time frame: baseline to 3 months post-treatment
Assessment of changes in the visual appearance, according to the Crow's Feet Grading Scale
Time frame: baseline to 3 months post-treatment
Subject satisfaction as assessed by Subject Satisfaction Questionnaire
Time frame: baseline to 3 months post-treatment
Comfort as assessed by Therapy Comfort Questionnaire
Time frame: from the first to the last treatment session, assessed up to 56 days
Incidence of Treatment-related Adverse Events
Time frame: baseline to 3 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with BTL-785 with the applicator BTL-785-7-11 in people with Periorbital Wrinkles and Periorbital Area, run by BTL Industries Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periorbital area improvement assessment (time frame: baseline to 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.