Device for Improving Skin Quality and Texture on the Face and Neck

NCT06645366 | Completed FDA Device

• 1 other identifier: BTL-785_CTUS1700
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to investigate the effect of the BTL-785F device (with BTL-785-4-4 tip on BTL-785-4 applicator) on the improvement of skin quality and texture on the face and neck in healthy adult volunteers. The main question it aims to answer is: Whether the BTL-785F device (with BTL-785-4-4 tip on BTL-785-4 applicator) is able to improve skin quality 3 months post-treatment, as assessed by two-dimensional and three-dimensional photographs. Participants will complete three treatments, and two follow-up visits.

Conditions

Wrinkle; Pigmentation; Skin Laxity; Skin Scarring

Keywords

skin; texture; wrinkles; skin quality

Outcome Measures

Primary Outcomes (1)

• Skin Quality Improvement Assessment

  The primary efficacy outcome measure is aesthetic improvement 3 months post-treatment, assessed using 2D photographs on the Global Aesthetic Improvement Scale (GAIS), as well as the degree of clinical improvement determined by automated analysis of 3D photographs using the 3D analysis device's software. Improvement is considered an increase in the GAIS score, as well as in the score determined by the 3D analysis device's software.

  12 months

Secondary Outcomes (3)

• Incidence of Treatment-related Adverse Events

  12 months

• Satisfaction Assessed by the Subject Satisfaction Questionnaire

  12 months

• Comfort Assessed by Therapy Comfort Questionnaire

  12 months

Study Arms (1)

Treatment with BTL-785F

EXPERIMENTAL

Three (3) treatment sessions will be applied to the subjects' face and neck using the BTL-785F system.

Device: Treatment with BTL-785F

Interventions

Treatment with BTL-785F DEVICE

Three (3) treatment sessions will be applied to the subjects' face and neck using the BTL-785F system equipped with the BTL-785-4-4 tip on BTL-785-4 applicator, lasting from 20 to 60 minutes depending on the size of the treated area. Each treatment will be spaced 2 - 6 weeks apart, after the complete healing of scabs.

Treatment with BTL-785F

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female subjects over 30 years of age seeking treatment for improvement in skin quality and texture on face and neck
• Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
• Subjects willing and able to abstain from partaking in any facial or neck 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 and neck without makeup 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 near the treatment area or neutral electrode
• Permanent implant in the treated area
• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
• Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
• History of any type of cancer
• Active collagen diseases
• Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis, and thrombosis)1
• Pregnancy/nursing or IVF procedure

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (3)

AboutSkin Dermatology & DermSurgery

Greenwood Village, Colorado, 80111, United States

Location

Capital Laser & Skin Care

Chevy Chase, Maryland, 20815, United States

Location

Boyd Beauty

Birmingham, Michigan, 48009, United States

Location

MeSH Terms

Conditions

Cutis Laxa; Cicatrix

Interventions

Therapeutics

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; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: October 15, 2024
• First Posted: October 16, 2024
• Study Start: June 24, 2024
• Primary Completion: April 29, 2025
• Study Completion: April 29, 2025
• Last Updated: September 16, 2025

Record last verified: 2024-10

Locations

US (3)