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Evaluation of Safety and Efficacy of the BTL-785F Device for Improvement in Skin Quality and Texture on Face and Neck
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.
Age
22 - No limit years
Sex
ALL
Healthy Volunteers
Yes
AboutSkin Dermatology & DermSurgery
Greenwood Village, Colorado, United States
Capital Laser & Skin Care
Chevy Chase, Maryland, United States
Boyd Beauty
Birmingham, Michigan, United States
Start Date
June 24, 2024
Primary Completion Date
April 29, 2025
Completion Date
April 29, 2025
Last Updated
September 16, 2025
39
ACTUAL participants
Treatment with BTL-785F
DEVICE
Lead Sponsor
BTL Industries Ltd.
NCT07187297
NCT07255261
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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