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.
This study will evaluate the safety and efficacy of the BTL-785F system equipped with the BTL-785-4-4 tip on BTL-785-4 applicator for the improvement of skin quality and texture on the face and neck. It is a prospective, multi-center, open label, one-arm study. Subjects will be required to complete three (3) treatment visits and two (2) follow-up visits (at 1 month, 3 months post-treatment). At baseline, inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient. 2D and 3D photographs of the subjects will be taken. The treatment administration phase consists of three (3) treatment visits, delivered 2 - 6 weeks apart, after the complete healing of scabs. Before the second and third treatment, 2D and 3D photographs will be taken. After each treatment, subjects will be asked to fill in the Therapy Comfort Questionnaire for the assessement of subjects' comfort during the treatments. After the last treament, subjects will receive Subject Satisfaction Questionnaire to record subjects' satisfaction with the treatment results. At both follow-up visits, subjects will receive Subject Satisfaction Questionnaire to fill in, and 2D and 3D photographs will be taken. Safety measures will include documentation of adverse events (AE) during and after the treatment procedures and at the follow-up visits, and if needed medical assistance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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.
AboutSkin Dermatology & DermSurgery
Greenwood Village, Colorado, United States
Capital Laser & Skin Care
Chevy Chase, Maryland, United States
Boyd Beauty
Birmingham, Michigan, United States
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.
Time frame: 12 months
Incidence of Treatment-related Adverse Events
To evaluate the safety of the BTL-785F device with the BTL-785-4-4 tip on the BTL-785-4 applicator for the improvement of skin quality and texture through monitoring of adverse reactions.
Time frame: 12 months
Satisfaction Assessed by the Subject Satisfaction Questionnaire
The 5-point Likert scale Subject Satisfaction Questionnaire will be used for the evaluation of satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last treatment, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' skin quality and overall facial appearance will vary from "strongly agree" to "strongly disagree".
Time frame: 12 months
Comfort Assessed by Therapy Comfort Questionnaire
The 5-point Likert scale Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. The Therapy Comfort questionnaire will be given to subjects after each treatment.
Time frame: 12 months
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