Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation

NCT05929625 | Completed FDA Device

• 1 other identifier: BTL-585F_100
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the clinical efficacy, safety and the performance of radiofrequency heating and ultrasound delivered by the BTL-585-2 applicator of the BTL-585F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity. The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF \& US) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) treatment visits and two to three follow-up visits.

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (2)

• Overall Wrinkle Severity Change assessed according to the Fitzpatrick Wrinkle and Elastosis Scale (FWES) up to 3 months posttreatment follow-up

  The Fitzpatrick Wrinkle and Elastosis Scale is a clinically validated assessment tool and will be used to assess skin wrinkle severity and elastosis on a scale from 1 to 9 (minimum 1 and maximum 9), where the lower score is considered better.

  3 months

• Change in overall facial appearance assessed according to the Global Aesthetic Improvement Scale (GAIS) up to 3 months posttreatment follow-up

  Three independent evaluators will evaluate before and after photographs and grade them for change. Using the same photographs, they will evaluate changes in overall facial appearance according to the Global Aesthetic Improvement scale. For reporting of outcomes, the higher the GAIS value, the greater the improvement in the range -1 to 3. The following criteria will be used: Grade 3: Very Much Improved Grade 2: Much Improved Grade 1: Improved Grade 0: No Change Grade -1: Worse.

  3 months

Secondary Outcomes (3)

• Assessment of the safety profile by recording adverse events and assessing the subject's discomfort and pain

  3 months

• Assessment of therapy comfort after the final study treatment based on a Therapy Comfort Questionnaire

  up to 8 weeks

• Assessment of subject's satisfaction with study treatment using the Subject Satisfaction Questionnaire

  3 months

Study Arms (2)

RF+US group

EXPERIMENTAL

Subjects will be treated with the subject device using both, radiofrequency and ultrasound energies simultaneously with regular treatment settings.

Device: BTL-585-2 RF+US

RF only group

EXPERIMENTAL

Subjects will be treated with the subject device using only radiofrequency energy with regular treatment settings.

Device: BTL-585-2 RF

Interventions

BTL-585-2 RF+US DEVICE

The subjects of RF+US group will receive four simultaneous RF+US treatments of the entire face area including forehead, upper and lower cheeks and area around eyes.

RF+US group

BTL-585-2 RF DEVICE

The subjects of RF only study group will receive four RF treatments of the entire face area including forehead, upper and lower cheeks and area around eyes.

RF only group

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 and reduction of facial wrinkles and facial skin laxity
• Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
• Presence of clearly visible wrinkles in the treated area when the face is relaxed 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:

• Bacterial or viral infection, acute inflammations
• Impaired immune system
• Isotretinoin 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 6 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 any type of cancer
• Active collagen diseases
• Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
• Pregnancy/nursing or IVF procedure

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (2)

BOYD Beauty

Birmingham, Michigan, 48009, United States

Location

Refresh Dermatology

Houston, Texas, 77081, United States

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study design is single blinded; only the subject will be unaware of the group assignment. The operator providing the treatment will be aware of the subject's group assignment and will perform the treatment with the setting according to the subject's group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF \& US) and B (only RF) which will receive a treatment with different settings.

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: July 3, 2023
• Study Start: October 28, 2020
• Primary Completion: February 23, 2022
• Study Completion: May 31, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)