Clinical trial NCT03548025: Safety and Efficacy of the BTL-FR2000 Device for the Treatment of Facial Wrinkles
Official title: Safety and Efficacy of the BTL-FR2000 Device for the Treatment of Facial Wrinkles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wrinkle
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate safety and effectivity of the BTL-FR2000 device for the treatment of facial wrinkles.

Detailed description: Subjects will be photographed at the baseline visit. After the treatment phase, subjects will be invited for two follow-up visits - 3 and 6 months after the last therapy. They will be again photographed.

Three blinded evaluators will be scoring the full face photos according to the Fitzpatrick Wrinkle Severity Scale. The improvement of the scores will be evaluated. Every subject will serve as its own control.

In addition, the occurence of an AE during the whole study, as well as the therapy discomfort during the treatment phase, will be followed.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 22 years
* Voluntarily signed informed consent form

Exclusion Criteria:

* Bacterial or viral infection, acute inflammations
* Impaired immune system
* Isotretinoin in the past 12 months
* Skin related autoimmune diseases
* Radiation therapy and chemotherapy
* Poor healing and unhealed wounds in the treatment area
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
* 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 3 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 kind of cancer
* Active collagen diseases
* Cardiovascular diseases (such as cardiac and vascular diseases, peripheral arterial disease, thrombophlebitis, thrombosis, etc.)
* 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
* Children under age of 21
* Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks
* Patients with allergy to anesthetics should not be treated under anesthesia
* Botox®/collagen/fat injections or other injected bio-material in the treated area within three months prior to treatment
* Use of non-steroidal anti-inflammatory drugs one week before and after each treatment session
* Treating over tattoo or permanent makeup

Primary outcomes:
measure: Improvement of facial wrinkles evaluated through the change in the value of the validated scale
timeFrame: 10 months
Secondary outcomes:
measure: Safety - Occurence of AE
timeFrame: 10 months
measure: Safety - Therapy comfort
timeFrame: 4 months
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Aesthe Clinic
Study officials:
References: