- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03776461
Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
August 3, 2023 updated by: Venus Concept
Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.
Study Overview
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 each treatment.
Subjects will be followed at 6 and 12 weeks after their last treatment.
Analysis will be performed on all subjects who receive at least one treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92130
- Scripps Clinic Carmel Valley
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 80-pin applicator
3 treatments with the 80-pin tip applicator at 0, 4, and 8 weeks.
|
The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
|
Active Comparator: 160 pin applicator
3 treatments with the 160-pin tip applicator at 0, 4, and 8 weeks.
|
The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Satisfaction
Time Frame: 12 Weeks Post Last Treatment (Around Week 20)
|
Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.
|
12 Weeks Post Last Treatment (Around Week 20)
|
Subject Satisfaction
Time Frame: 6 Weeks Post Last Treatment (Around Week 14)
|
Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.
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6 Weeks Post Last Treatment (Around Week 14)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Scale - Visual Analog Scale for Pain
Time Frame: Post Treatment at the Baseline, 4 Week and 8 Week treatment visits
|
Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being pain as bad as it can be.
For each subject, the mean VAS score was taken from the 3 treatments.
|
Post Treatment at the Baseline, 4 Week and 8 Week treatment visits
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Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.
Time Frame: Post Treatment at the Baseline, 4 Week and 8 Week treatment visits
|
Subject's assessment of treatment tolerability as measured by a 5-point scale.
For each subject the mean of tolerability results from the 3 treatments was taken.
|
Post Treatment at the Baseline, 4 Week and 8 Week treatment visits
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Matthew Gronski, Venus Concept
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2019
Primary Completion (Actual)
June 18, 2021
Study Completion (Actual)
June 18, 2021
Study Registration Dates
First Submitted
December 12, 2018
First Submitted That Met QC Criteria
December 13, 2018
First Posted (Actual)
December 14, 2018
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
August 3, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- VI0918
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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