Fat BurnNCT06282172
Histological Evaluation of BTL-785F Device's Effect on Submental Subcutaneous Adipose Tissue
A study testing Treatment with BTL-785-7 in people with Fat Burn, run by BTL Industries Ltd. at 1 site in United States.
Trial summary
This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fat Burn
- What is being tested?
- Treatment with BTL-785-7
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2023to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 treatment for reduction of submental fat
- Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
- Presence of clearly visible excess fat in submentum 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 undergo punch biopsy of the submental area
Who cannot join
- Local bacterial or viral infection in the area to be treated
- Local acute inflammation in the area to be treated
- Impaired immune system caused by any immunosuppressive illness, disease or medication
- Isotretinoin and tretinoin-containing medication use in the past 12 months
- Skin related autoimmune diseases
- Radiation therapy and/or chemotherapy
Show all 31Show fewer
- Poor healing and unhealed wounds in the treatment area
- Metal implants
- Permanent implant in the treated area
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
- Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
- Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
- History of skin disorders, keloids, abnormal wound healing and dry or fragile skin
- History of any type of cancer
- Active collagen diseases
- Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis, hypersensitive carotid sinus 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
- Acute neuralgia and neuropathy
- Kidney or liver failure
- Nerve insensitivity (sensitivity disorders) to heat in the treatment area
- Varicose veins, pronounced edemas
- Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion
- Unwillingness/inability to not change their usual cosmetics and especially not to use fat reduction, anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
- Electroanalgesia without exact diagnosis of pain etiology
- Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
- Blood vessels and lymphatic vessels inflammation
- Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Schweiger Dermatology PC, Research Division
Hackensack, New Jersey, 07601
About this study
Official title: Effect of Treatment With BTL-785F Device on Submental Subcutaneous Adipose Tissue - Histological Evaluation
This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat.
Read the detailed description
This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat. The changes in the fat tissue related to the morphology (shape, size and count) will be assessed histologically. The presence of biochemical apoptotic indicators will be analysed in the adipocytes.
The study is a prospective single-center open-label two-arm study. The subjects will be enrolled and assigned into two study groups; Group A which will receive active treatment (5 subjects) and Group B (2 subjects), will serve as the control, and will not receive any treatment to verify the treatment outcomes.
Subjects will be required to complete one (1) treatment visit and three (3) follow-up visits (at 24 hours, 7 days and 14 days post treatment). The third follow-up visit is for safety evaluation.
At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient.
Punch biopsies (3mm diameter) will be obtained from the treatment area for histologic analysis. In the control group, biopsy will be obtained from the location corresponding to the treatment area in the active group.
Safety measures will include documentation of adverse events (AE) during and after the treatment procedures and at the follow up visits and if needed medical assistance.
- Conditions
- Fat Burn
- Being tested
- Treatment with BTL-785-7
- Keywords
- submentum, fat reduction, adipocyte, apoptosis, double chin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with BTL-785-7Device
Treatment with BTL-785-7 delivering simultaneously radiofrequency (RF) and HIFES energy on the submental area
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BTL-785-7 | Experimental | Active treatment with BTL-785-7 Receives: Device: Treatment with BTL-785-7 |
| Control | No intervention | No active treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the effects of the BTL-785F device (with BTL-785-7 applicator) on the morphology of submental adipose cells.
Histological evaluation of changes in the shape and size of submental adipose cells, based on biopsies obtained from both the treatment and control groups.
Measured: 6 months
Secondary outcomes (3)
Investigation of post-treatment adipocyte apoptosis
Histologically analyze the adipocyte tissue for the change in apoptosis markers (caspase-3/7 and Bcl-2) levels.
Measured: 6 months
Incidence of Treatment-related Adverse Events
Evaluation of the safety of the BTL-785F device with BTL-785-7 applicator for non-invasive treatment of the submental area throught monitoring of adverse events
Measured: 6 months
Comfort Evaluation Assessed by Therapy Comfort Questionnaire
Evaluation of therapy comfort using the 5-point Likert scale Therapy Comfort Questionnaire given to subjects after the treatment, where the best possible answer would be "strongly agree" and the worst "strongly disagree". The questionnaire includes pain sensation rating on the scale from 0 (no pain) to 10 (worst possible pain), where 0 (no pain) represents the best possible outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start25 Jul 2023
- Primary completion31 Oct 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fat BurnStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282172
- Sponsor's protocol ID
- BTL-785_CTUS1600
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Goldberg DJ. Adipocyte Apoptosis Following a Novel Method for Double Chin Reduction: A Pilot Human Histology Study. J Cosmet Dermatol. 2025 Jan;24(1):e16643. doi: 10.1111/jocd.16643. Epub 2024 Nov 13.
PubMed 39536780
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment With BTL-785F Device on Submental Subcutaneous Adipose Tissue - Histological Evaluation
- ClinicalTrials.gov ID
- NCT06282172
- Acronym / sponsor ID
- BTL-785_CTUS1600
- Conditions
- Fat Burn
- Keywords
- submentum, fat reduction, adipocyte, apoptosis, double chin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 28 Feb 2024 (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.
This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat.
Detailed description
This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat. The changes in the fat tissue related to the morphology (shape, size and count) will be assessed histologically. The presence of biochemical apoptotic indicators will be analysed in the adipocytes.
The study is a prospective single-center open-label two-arm study. The subjects will be enrolled and assigned into two study groups; Group A which will receive active treatment (5 subjects) and Group B (2 subjects), will serve as the control, and will not receive any treatment to verify the treatment outcomes.
Subjects will be required to complete one (1) treatment visit and three (3) follow-up visits (at 24 hours, 7 days and 14 days post treatment). The third follow-up visit is for safety evaluation.
At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient.
Punch biopsies (3mm diameter) will be obtained from the treatment area for histologic analysis. In the control group, biopsy will be obtained from the location corresponding to the treatment area in the active group.
Safety measures will include documentation of adverse events (AE) during and after the treatment procedures and at the follow up visits and if needed medical assistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with BTL-785-7 | Experimental | Device: Treatment with BTL-785-7Active treatment with BTL-785-7 |
| Control | No intervention | –No active treatment |
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 treatment for reduction of submental fat
- Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
- Presence of clearly visible excess fat in submentum 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 undergo punch biopsy of the submental area
Key exclusion criteria (31 listed)
- Local bacterial or viral infection in the area to be treated
- Local acute inflammation in the area to be treated
- Impaired immune system caused by any immunosuppressive illness, disease or medication
- Isotretinoin and tretinoin-containing medication use in the past 12 months
- Skin related autoimmune diseases
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-785-7Treatment with BTL-785-7 delivering simultaneously radiofrequency (RF) and HIFES energy on the submental area | Device | Treatment with BTL-785-7 |
Primary outcome
Investigation of the effects of the BTL-785F device (with BTL-785-7 applicator) on the morphology of submental adipose cells.
Time frame: 6 months
Histological evaluation of changes in the shape and size of submental adipose cells, based on biopsies obtained from both the treatment and control groups.
3 secondary outcomes
Investigation of post-treatment adipocyte apoptosis
Time frame: 6 months
Incidence of Treatment-related Adverse Events
Time frame: 6 months
Comfort Evaluation Assessed by Therapy Comfort Questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 39536780Goldberg DJ. Adipocyte Apoptosis Following a Novel Method for Double Chin Reduction: A Pilot Human Histology Study. J Cosmet Dermatol. 2025 Jan;24(1):e16643. doi: 10.1111/jocd.16643. Epub 2024 Nov 13.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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-785-7 in people with Fat Burn, run by BTL Industries Ltd. at 1 site 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 31 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: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigation of the effects of the BTL-785F device (with BTL-785-7 applicator) on the morphology of submental adipose cells. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06282172, which also lists 1 linked publication.
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 7 Feb 2025.