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

Completed · Not applicable

Conditions studied: Wrinkle, Pigmentation, Skin Laxity, Skin Scarring

In brief

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.

Key facts

Study ID

NCT06645366

Run by

BTL Industries Ltd.

People needed

39

Starts

2024-06-24

Expected to finish

2025-04-29

Last updated by the study team

2025-09-16

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

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
• History of bleeding coagulopathies, use of anticoagulants
• Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
• Any surgical procedure in the treatment area within the last three months or before complete healing
• Poorly controlled endocrine disorders, such as diabetes
• Tuberculosis
• Hepatitis
• Febrile conditions
• Unwillingness/inability to not change their usual cosmetics and especially not to use anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
• History of skin disorders, keloids, abnormal wound healing and dry or fragile skin
• Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks

Where it is running

• AboutSkin Dermatology & DermSurgery — Greenwood Village, Colorado, United States
• Capital Laser & Skin Care — Chevy Chase, Maryland, United States
• Boyd Beauty — Birmingham, Michigan, United States

Full record on ClinicalTrials.gov

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