This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-2 applicator for non-invasive treatment of facial wrinkles.
This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-2 applicator for non-invasive treatment of facial wrinkles. The study is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete three (3) treatment visits and two follow-up visits. At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device. Safety measures will include documentation of adverse events (AE) during and after the procedures. Follow-ups visits at 3 months and 6 months after the final treatment will be held.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Application of radiofrequency field which provides controlled heating to the skin.Therapeutic effect is observed when the tissue temperature reaches 40-45 degrees Celsius.
Dermatological center "Lege Artis"
Stara Zagora, Bulgaria
Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale
Gathering of clinical evidence that the Device is able to achieve reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale score according to at least 2 out of 3 blinded dermatologists at 3-months follow-up compared to baseline.
Time frame: 3 months
Assess safety profile by recording of adverse events
All AEs including local and systemic reactions not meeting the criteria for "serious adverse events" will be captured on the appropriate CRF. Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed only by those with the training and authority to make a diagnosis, which would include MD, DDS, DMD, PA, Nurse Practitioner or DO), and time of resolution/stabilization of the event. All AEs occurring during the study must be documented appropriately regardless of relationship to study device. All AEs will be followed to adequate resolution.
Time frame: 7 months
Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire
Every subject who completed the treatment will be asked to fill in the Satisfaction Questionnaire at the 3 months follow-up and the 6 months follow-up. This evaluation should reflect overall satisfaction with the results compared to therapy comfort, experienced pain, duration, and application convenience. Subjects will be asked: "Overall how are you satisfied with the therapy?" 1 = very satisfied; 2 = satisfied; 3 = neither/nor; 4 = unsatisfied; 5 = very unsatisfied.
Time frame: 6 months
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