BTL-785F Device for Non-invasive Reduction of Wrinkles and Overall Facial Improvement
NCT ID: NCT05524779
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2022-10-19
2024-06-25
Brief Summary
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Detailed Description
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At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.
The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart.
Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to the every other procedure and at the follow-ups. Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BTL-785-7 Treatment
Treatment of wrinkles with the BTL-785-7 applicator to the BTL-785F system.
BTL-785-7
Treatment with the BTL-785-7 applicator to the BTL-785F system.
Interventions
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BTL-785-7
Treatment with the BTL-785-7 applicator to the BTL-785F system.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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 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
* Electroanalgesia without exact diagnosis of pain etiology
* Application in the area of chest, heart or over the eyes
* Serious psychopathological disorders (such as schizophrenia)
* Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
* Blood vessels and lymphatic vessels inflammation
21 Years
ALL
Yes
Sponsors
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BTL Industries Ltd.
INDUSTRY
Responsible Party
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Locations
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Contour Medical
Gilbert, Arizona, United States
Holden Timeless Beauty
San Marcos, California, United States
Precision Skin Institute
Davie, Florida, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
Jennifer Levine MD
New York, New York, United States
Countries
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Other Identifiers
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BTL-785_CTUS1300
Identifier Type: -
Identifier Source: org_study_id