CelluliteNCT05624216
Radiofrequency and Targeted Pressure Energy for Cellulite Reduction
A study testing BTL-084 in people with Cellulite and Cellulitis, run by BTL Industries Ltd. at 1 site in United States.
Trial summary
This study will evaluate the clinical efficacy and safety of radiofrequency heating and targeted pressure energy for reduction in the appearance or cellulite. The study is a prospective multi-center open-label single-arm study. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cellulite, Cellulitis, Cellulitis of Leg
- What is being tested?
- BTL-084
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2019to 25 Oct 2021
- 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
- Voluntarily signed informed consent form
- Age ≥ 21 years
- Subject suffer from Grade 2 or Grade 3 cellulite as per Nürnberger-Muller Scale
- Subject did not experience weight change exceeding 2.5 kg (5 lb) in the preceding month
- BMI ≤ 33 kg/m2
- Women of childbearing potential are required to use birth control measures during the whole duration of the study
- Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote skin tightening and cellulite reduction during study participation
- Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation
Who cannot join
- Bacterial or viral infection, acute inflammations
- Impaired immune system
- Autoimmune disease
- Diabetes
- Herpes Simplex
- Isotretinoin in the past 12 months
Show all 27Show fewer
- Scleroderma
- Radiation therapy
- Burns in the treatment area
- Poor healing in the treatment area
- Metal implants
- Implantable pacemaker or automatic defibrillator / cardioverter
- Ablative / non-ablative cosmetic intervention (deep peeling) in the past 3 months
- Cancer and tumor diseases
- Active collagen diseases
- Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
- Pregnancy / nursing or IVF procedure
- Acute neuralgia and neuropathy
- Blood disorders, risk of bleeding, bleeding tissues, peptic ulcers
- Eczema
- Rosacea
- Febrile conditions
- Kidney or liver failure
- Pronounced edemas, ascites, exudates
- Sensitivity disorders in the treatment area
- Varicose veins
- Local corticosteroid therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Busso Cosmetic Dermatology
Coconut Grove, Florida, 33133
About this study
This study will evaluate the clinical efficacy and safety of radiofrequency heating and targeted pressure energy for reduction in the appearance or cellulite. The study is a prospective multi-center open-label single-arm study. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits - 1, 3 and 6 months after the last therapy visit. All of the study subjects will receive the treatment with the subject device.
Read the detailed description
This study will evaluate the clinical efficacy and safety of radiofrequency heating and targeted pressure energy for reduction in the appearance or cellulite. The study is a prospective multi-center open-label single-arm study. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits - 1, 3 and 6 months after the last therapy visit. All of the study subjects will receive the treatment with the subject device.
At the baseline visit subject's weight will be recorded, together with hip and thigh circumference. In addition, photographs of the treated area will be taken.
The treatment administration phase will consist of four (4) treatments, delivered in 2-4 weeks. The applicator will be applied over the treatment area.
At the last therapy visit, the subject's weight will be recorded, together with hip and thigh circumference. Photographs of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire and Therapy Comfort Questionnaire to fill in.
Safety measures will include documentation of adverse events (AE). Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
- Conditions
- Cellulite, Cellulitis, Cellulitis of Leg
- Being tested
- BTL-084
- Medical subject headings
- Cellulite, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-084Device
Also called Emtone
Radiofrequency and targeted pressure energy devices for the treatment of cellulite
| Study group | Role | What they receive |
|---|---|---|
| BTL-084 Treatment | Experimental | Radiofrequency and targeted pressure energy devices for the treatment of cellulite Receives: Device: BTL-084 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of cellulite severity change based on photographs before and after the study procedure according to the Cellulite Severity Scale
Three independent evaluators will evaluate photographs for a level of cellulite severity by assigning a score according to the Cellulite Severity Scale (CSS) validated by Hexsel et al. After follow-up visits are conducted, evaluators will be given a set of the coded photographs from each subject for an evaluation. The Cellulite Severity Scale evaluates five key morphological features of cellulite; number of depressions, depth of depressions, clinical appearance of evident raised lesions, presence of flaccidity and the grade of cellulite. Each item is graded from 0 to 3, allowing final classification of cellulite as mild, moderate and severe.
Measured: 6 months
Photography evaluation according to the Global Aesthetic Improvement scale
Three independent evaluators will evaluate photographs for a level of appearance change by assigning a score according to the Global Aesthetic Improvement scale, where the lowest possible grade is (-1), worsened state and the highest is (3) very much improved.
Measured: 6 months
Hip and Thigh Circumference Measure
Hip and thigh circumference measurements will be conducted at the baseline visit, after the last treatment and during all follow-up visits.
Measured: 6 months
Secondary outcomes (2)
Therapy Comfort
The 10-point scale will be used for evaluating the comfort during the study treatment. Subjects will be evaluating the comfort/discomfort on a scale from 1 ("No discomfort") to 10 ("Unbearable discomfort")
Measured: 6 months
Subject Satisfaction
The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome. The subjects will be answering questions with possible answers varying from "Strongly disagree" to "Strongly agree"
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 posted22 Nov 2022
- Study start30 Jul 2019
- Primary completion8 Apr 2020
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CelluliteStudies 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
- 28 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
- NCT05624216
- Sponsor's protocol ID
- BTL-084_100
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency and Targeted Pressure Energy for Cellulite Reduction
- ClinicalTrials.gov ID
- NCT05624216
- Acronym / sponsor ID
- BTL-084_100
- Conditions
- Cellulite, Cellulitis, Cellulitis of Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 22 Nov 2022 (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 will evaluate the clinical efficacy and safety of radiofrequency heating and targeted pressure energy for reduction in the appearance or cellulite. The study is a prospective multi-center open-label single-arm study. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits - 1, 3 and 6 months after the last therapy visit. All of the study subjects will receive the treatment with the subject device.
Detailed description
This study will evaluate the clinical efficacy and safety of radiofrequency heating and targeted pressure energy for reduction in the appearance or cellulite. The study is a prospective multi-center open-label single-arm study. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits - 1, 3 and 6 months after the last therapy visit. All of the study subjects will receive the treatment with the subject device.
At the baseline visit subject's weight will be recorded, together with hip and thigh circumference. In addition, photographs of the treated area will be taken.
The treatment administration phase will consist of four (4) treatments, delivered in 2-4 weeks. The applicator will be applied over the treatment area.
At the last therapy visit, the subject's weight will be recorded, together with hip and thigh circumference. Photographs of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire and Therapy Comfort Questionnaire to fill in.
Safety measures will include documentation of adverse events (AE). Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTL-084 Treatment | Experimental | Device: BTL-084Radiofrequency and targeted pressure energy devices for the treatment of cellulite |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily signed informed consent form
- Age ≥ 21 years
- Subject suffer from Grade 2 or Grade 3 cellulite as per Nürnberger-Muller Scale
- Subject did not experience weight change exceeding 2.5 kg (5 lb) in the preceding month
- BMI ≤ 33 kg/m2
Key exclusion criteria (27 listed)
- Bacterial or viral infection, acute inflammations
- Impaired immune system
- Autoimmune disease
- Diabetes
- Herpes Simplex
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 |
|---|---|---|
| BTL-084Also: EmtoneRadiofrequency and targeted pressure energy devices for the treatment of cellulite | Device | BTL-084 Treatment |
Primary outcome
Evaluation of cellulite severity change based on photographs before and after the study procedure according to the Cellulite Severity Scale
Time frame: 6 months
Three independent evaluators will evaluate photographs for a level of cellulite severity by assigning a score according to the Cellulite Severity Scale (CSS) validated by Hexsel et al. After follow-up visits are conducted, evaluators will be given a set of the coded photographs from each subject for an evaluation. The Cellulite Severity Scale evaluates five key morphological features of cellulite; number of depressions, depth of depressions, clinical appearance of evident raised lesions, presence of flaccidity and the grade of cellulite. Each item is graded from 0 to 3, allowing final classification of cellulite as mild, moderate and severe.
Photography evaluation according to the Global Aesthetic Improvement scale
Time frame: 6 months
Three independent evaluators will evaluate photographs for a level of appearance change by assigning a score according to the Global Aesthetic Improvement scale, where the lowest possible grade is (-1), worsened state and the highest is (3) very much improved.
Hip and Thigh Circumference Measure
Time frame: 6 months
Hip and thigh circumference measurements will be conducted at the baseline visit, after the last treatment and during all follow-up visits.
2 secondary outcomes
Therapy Comfort
Time frame: 6 months
Subject Satisfaction
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 22 Nov 2022.
- 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 BTL-084 in people with Cellulite and Cellulitis, 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 8 inclusion and 27 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 22 Nov 2022. 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?
Evaluation of cellulite severity change based on photographs before and after the study procedure according to the Cellulite Severity Scale (time frame: 6 months). The study lists 3 primary outcomes in all. 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 22 Nov 2022.