The study of BTL-785F Device for non-invasive treatment of wrinkles

The research company BTL Industries Ltd is conducting the clinical trial BTL-785F Device for Non-invasive Treatment of Wrinkles and Improvement of the Face Appearance.

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive treatment of facial wrinkles.

It is planned to include 22 participants.

Actual study start date is June 6, 2022. The researchers expect to complete the study by February 2023.

One primary outcome measure is Noninvasive Treatment Of Wrinkles, Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. Baseline and post-treatment photographs will be evaluated. A statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale should be achieved.

Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05524805.