Status:
COMPLETED
Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles
Lead Sponsor:
BTL Industries Ltd.
Conditions:
Wrinkle
Eligibility:
All Genders
21-70 years
Phase:
NA
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 sin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2021
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04447963
Start Date
June 15 2020
End Date
June 28 2021
Last Update
November 10 2021
Active Locations (1)
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1
Dermatological center "Lege Artis"
Stara Zagora, Bulgaria