Clinical trial NCT04447963: Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles
Official title: Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects over 21 years of age seeking treatment and reduction of facial wrinkles
* Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
* Presence of clearly visible wrinkles in the treated area when the face is relaxed as deemed appropriate by the Investigator
* Subjects willing and able to abstain from partaking in any facial 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 taken

Exclusion Criteria:

* Bacterial or viral infection, acute inflammations
* Impaired immune system
* Isotretinoin 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
* Permanent implant in the treated area
* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
* Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 6 months prior to the treatment
* 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)
* 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
* Acute neuralgia and neuropathy
* Kidney or liver failure
* Sensitivity disorders in the treatment area
* Varicose veins, pronounced edemas
* Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion
* Unwillingness/inability to not change their usual cosmetics and especially not to use ani-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
* Unwillingness/inability to abstain from cosmetic procedures in the treated area at least 15 days before every examination with the facial image analysis system VISIA
* Any other disease or condition (e.g. eye disease) at the investigator discretion that may pose risk to the patient or compromise the study

Primary outcomes:
measure: Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale
timeFrame: 3 months
Secondary outcomes:
measure: Assess safety profile by recording of adverse events
timeFrame: 7 months
measure: Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Stara Zagora
country: Bulgaria
facility: Dermatological center "Lege Artis"
Study officials:
affiliation: Dermatologist
name: Evgeni Hristozov, MD
role: PRINCIPAL_INVESTIGATOR
References: