Device for Improving Skin Quality and Texture on the Face and Neck (NCT06645366) | Clinical Trial Compass
CompletedNot Applicable
Device for Improving Skin Quality and Texture on the Face and Neck
United States39 participantsStarted 2024-06-24
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 arte…