Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Submental Fat

NCT05831332 | Completed

• 1 other identifier: BTL-785_CTBG200
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment.

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (1)

• Change of submental fat thickness

  To gather clinical evidence that BTL-785F system equipped with BTL-785-7 applicator is able to provide reduction of submental fat thickness.

  6 months

Secondary Outcomes (2)

• Evaluation the effect on submental skin laxity

  6 months

• Evaluation the safety of the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat.

  6 months

Study Arms (1)

BTL-785-7 Treatment

EXPERIMENTAL

Treatment with the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat.

Device: BTL-785-7

Interventions

BTL-785-7 DEVICE

Treatment with the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat.

BTL-785-7 Treatment

Eligibility Criteria

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

You may qualify if:

• 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 have photographs of their face taken

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Center for specialized medical care - Individual dermatological practice Dr. Mariya Genova

Plovdiv, 4000, Bulgaria

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

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: April 14, 2023
• First Posted: April 26, 2023
• Study Start: March 6, 2023
• Primary Completion: August 30, 2023
• Study Completion: October 25, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

BU (1)