Radiofrequency and Targeted Pressure Energy for Cellulite Reduction

NCT05624216 | Completed FDA Device

• 1 other identifier: BTL-084_100
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Cellulite; Cellulitis; Cellulitis of Leg

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  6 months

Secondary Outcomes (2)

• Therapy Comfort

  6 months

• Subject Satisfaction

  6 months

Study Arms (1)

BTL-084 Treatment

EXPERIMENTAL

Radiofrequency and targeted pressure energy devices for the treatment of cellulite

Device: BTL-084

Interventions

BTL-084 DEVICE

Radiofrequency and targeted pressure energy devices for the treatment of cellulite

Also known as: Emtone

BTL-084 Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Dr. Busso Cosmetic Dermatology

Coconut Grove, Florida, 33133, United States

Location

MeSH Terms

Conditions

Cellulite; Cellulitis

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: July 30, 2019
• Primary Completion: April 8, 2020
• Study Completion: October 25, 2021
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)