Status:
COMPLETED
Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Lead Sponsor:
Venus Concept
Conditions:
Rhytides
Wrinkle
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.
Detailed Description
The study will evaluate 50 treatment sites in subjects requesting treatment of their facial wrinkles. The study will involve three treatments on both sides of the face with 3-5 week intervals between ...
Eligibility Criteria
Inclusion
- Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their facial wrinkles.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.
Exclusion
- Implantable defibrillators, cardiac pacemakers, and other metal implants
- Subjects with any implantable metal device in the treatment area
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
- Current or history of any kind of cancer, or pre-malignant moles.
- Severe concurrent conditions, such as cardiac disorders.
- Pregnancy or intending to become pregnant during the study and nursing.
- Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
- History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment , or according to Investigator's discretion .
- Poorly controlled endocrine disorders, such as diabetes.
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
- History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
- Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
- Use of isotretinoin (Accutane®) or other retinoids within six months prior to treatment or as per physician's discretion.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session.
- Any surgical procedure in the treatment area within the last six months or before complete healing.
- Treating over tattoo or permanent makeup.
- Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
- As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
Key Trial Info
Start Date :
March 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03776461
Start Date
March 8 2019
End Date
June 18 2021
Last Update
August 15 2023
Active Locations (1)
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1
Scripps Clinic Carmel Valley
San Diego, California, United States, 92130