NCT06282172

Brief Summary

This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

February 12, 2024

Last Update Submit

February 5, 2025

Conditions

Fat Burn

Keywords

submentumfat reductionadipocyteapoptosisdouble chin

Outcome Measures

Primary Outcomes (1)

  • Investigation of the effects of the BTL-785F device (with BTL-785-7 applicator) on the morphology of submental adipose cells.

    Histological evaluation of changes in the shape and size of submental adipose cells, based on biopsies obtained from both the treatment and control groups.

    6 months

Secondary Outcomes (3)

  • Investigation of post-treatment adipocyte apoptosis

    6 months

  • Incidence of Treatment-related Adverse Events

    6 months

  • Comfort Evaluation Assessed by Therapy Comfort Questionnaire

    6 months

Study Arms (2)

Treatment with BTL-785-7

EXPERIMENTAL

Active treatment with BTL-785-7

Device: Treatment with BTL-785-7

Control

NO INTERVENTION

No active treatment

Interventions

Treatment with BTL-785-7DEVICE

Treatment with BTL-785-7 delivering simultaneously radiofrequency (RF) and HIFES energy on the submental area

Treatment with BTL-785-7

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 undergo punch biopsy of the submental area

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
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schweiger Dermatology PC, Research Division

Hackensack, New Jersey, 07601, United States

Location

Related Publications (1)

  • Goldberg DJ. Adipocyte Apoptosis Following a Novel Method for Double Chin Reduction: A Pilot Human Histology Study. J Cosmet Dermatol. 2025 Jan;24(1):e16643. doi: 10.1111/jocd.16643. Epub 2024 Nov 13.

    PMID: 39536780DERIVED

MeSH Terms

Interventions

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 28, 2024

Study Start

July 25, 2023

Primary Completion

October 31, 2023

Study Completion

December 18, 2023

Last Updated

February 7, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)