Clinical trial NCT05624216: Radiofrequency and Targeted Pressure Energy for Cellulite Reduction
Official title: Radiofrequency and Targeted Pressure Energy for Cellulite Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cellulite
Cellulitis
Cellulitis of Leg
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-22
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluation of cellulite severity change based on photographs before and after the study procedure according to the Cellulite Severity Scale
timeFrame: 6 months
measure: Photography evaluation according to the Global Aesthetic Improvement scale
timeFrame: 6 months
measure: Hip and Thigh Circumference Measure
timeFrame: 6 months
Secondary outcomes:
measure: Therapy Comfort
timeFrame: 6 months
measure: Subject Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Coconut Grove
country: United States
facility: Dr. Busso Cosmetic Dermatology
state: Florida
Study officials:
References: