An interventional study of BTL-785-7 in Wrinkle, sponsored by BTL Industries Ltd.. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
This study will evaluate the clinical efficacy, safety and the performance of the BTL-785-7 applicator of the BTL-785F system for non-invasive treatment of facial wrinkles and overall improvement of facial appearance.
The changes in the skin related to the connective tissue structural proteins (i. e. elastin and collagen fibers) will be assessed histologically. The study is a prospective, single-center, two-arm, open-label study. The subjects will be enrolled and assigned into two groups; Group A (RF \& EMF) and Control group, which will not receive any treatment.
At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies of the facial skin (preauricular area) for the examination of changes related to skin's connective tissue, and photographs of the treated area will be taken.
The treatment administration phase in the treatment group will consist of four (4) treatment visits, delivered 5-10 days apart.
BTL Industries Ltd. is the lead sponsor of 71 studies on the registry; 4 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Subjects will be enrolled for an active treatment with BTL-785F device (BTL-785-7 applicator) for non-invasive facial rejuvenation.
Device: BTL-785-7
One subject will serve as a control.
Treatment with BTL-785F device (BTL-785-7 applicator) for non-invasive facial rejuvenation.
Histological examination
Evaluation of the facial skin to assess the changes related to connective tissue structural proteins in the biopsies obtained from the treatment group and control. Subjects will have one 3 mm punch biopsy obtained at the baseline and subsequent biopsies at the follow-up visits.
Time frame: 5 months
Subject Satisfaction
The 7-point Likert scale Subject Satisfaction Questionnaire will be used for evaluating the satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last therapy, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' overall skin and face appearance will vary from "strongly agree" to "strongly disagree".
Time frame: 5 months
Therapy Comfort
The 7-point Likert scale Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. Pain sensation will be rated by the subjects from 0 (no pain) to 10 (worst possible pain).
Time frame: 5 months
Evaluation of Wrinkle Severity
Three independent evaluators will evaluate changes of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale (FWES) using the photographs of treated areas for wrinkles (left and right cheeks and the forehead) taken at the baseline, last therapy visit and each follow-up visit. Wrinkle severity improvement according to FWES is considered when there is a decrease in score of the scale. The baseline and post-treatment scores will be compared. If applicable, the statistical significance of obtained results will be analyzed in Microsoft Excel spreadsheet software. The level of significance (α) will be set as 5%.
Time frame: 5 months
Evaluation of Overall Facial Appearance According to GAIS
Three evaluators will evaluate facial appearance in the treatment group according to the Global Aesthetic Improvement Scale (GAIS) using the photographs taken at the baseline, last therapy visit and both follow-up visits. Each evaluator will be asked to assign a score to a set of photographs. Facial appearance improvement to GAIS is considered when there is an increase in score of the scale. The baseline and post-treatment scores will be compared. If applicable, the statistical significance of obtained results will be analyzed in Microsoft Excel spreadsheet software. The level of significance (α) will be set as 5%.
Time frame: 5 months
Plan to share: No
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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BTL Industries Ltd.