Back to resultsRadiofrequency and Targeted Pressure Energy for Cellulite Reduction
Primary Purpose
Cellulite, Cellulitis, Cellulitis of Leg
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BTL-084
Sponsored by
About this trial
This is an interventional treatment trial for Cellulite
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Bacterial or viral infection, acute inflammations Impaired immune system Autoimmune disease Diabetes Herpes Simplex Isotretinoin in the past 12 months 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
Sites / Locations
- Dr. Busso Cosmetic Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BTL-084 Treatment
Arm Description
Radiofrequency and targeted pressure energy devices for the treatment of cellulite
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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")
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"
Full Information
NCT ID
NCT05624216
First Posted
November 14, 2022
Last Updated
November 14, 2022
Sponsor
BTL Industries Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05624216
Brief Title
Radiofrequency and Targeted Pressure Energy for Cellulite Reduction
Official Title
Radiofrequency and Targeted Pressure Energy for Cellulite Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
October 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BTL Industries Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite, Cellulitis, Cellulitis of Leg
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BTL-084 Treatment
Arm Type
Experimental
Arm Description
Radiofrequency and targeted pressure energy devices for the treatment of cellulite
Intervention Type
Device
Intervention Name(s)
BTL-084
Other Intervention Name(s)
Emtone
Intervention Description
Radiofrequency and targeted pressure energy devices for the treatment of cellulite
Primary Outcome Measure Information:
Title
Evaluation of cellulite severity change based on photographs before and after the study procedure according to the Cellulite Severity Scale
Description
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.
Time Frame
6 months
Title
Photography evaluation according to the Global Aesthetic Improvement scale
Description
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.
Time Frame
6 months
Title
Hip and Thigh Circumference Measure
Description
Hip and thigh circumference measurements will be conducted at the baseline visit, after the last treatment and during all follow-up visits.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Therapy Comfort
Description
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")
Time Frame
6 months
Title
Subject Satisfaction
Description
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"
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Bacterial or viral infection, acute inflammations
Impaired immune system
Autoimmune disease
Diabetes
Herpes Simplex
Isotretinoin in the past 12 months
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
Facility Information:
Facility Name
Dr. Busso Cosmetic Dermatology
City
Coconut Grove
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Radiofrequency and Targeted Pressure Energy for Cellulite Reduction
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