- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03002194
Change in Skin Elasticity With RF and PEMF
April 14, 2020 updated by: Venus Concept
Change in Skin Elasticity After Combined Radiofrequency and Electromagnetic Treatment
This study will measure the difference in skin elasticity in females only before and after treatment with radiofrequency and pulsed electromagnetic field therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is an open-label, baseline-controlled, single-center study to measure the change in skin elasticity after combined radio frequency (RF) and pulsed electromagnetic field (PEMF) treatment.
Forty-five adult females will undergo weekly treatments over a period of 8 weeks.
Skin elasticity will be measured by a Cutometer® prior to beginning treatment, week 7 and 3 months after completion of treatment.
Photographs will be taken prior to treatment, at week 4, week 7 and 3 months after completion of treatment.
Patient discomfort/pain and satisfaction questionnaires will be completed before, during and after treatment.
Study Type
Interventional
Enrollment (Actual)
48
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
-
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Ontario
-
North York, Ontario, Canada, M2N 6H7
- Art of Facial Surgery
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-
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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy adult female subject, 18 years of age and older with Fitzpatrick skin types I-IV
- Ability to tolerate the RF/PEMF procedure, and willing to adhere to the treatment regimen
Exclusion Criteria:
- Having any active electrical implant or permanent implant anywhere in the body, e.g. pacemaker, internal defibrillator
- Prior use of retinoids in treated area within 2 weeks of initial treatment
- Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment
- Patient on systemic corticosteroid therapy 6 months prior to start of study
- Prior use of collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 4-6 weeks of initial treatment. Treatment may not be performed at all over permanent dermal implants.
- Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment
- Any other surgery in treated area within 12 months of initial treatment
- History of keloid formation or poor wound healing in a previously injured skin area
- Epidermal or dermal disorders
- Open laceration or abrasion of any sort on the area to be treated.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- Having any form of active cancer at the time of enrollment
- Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the treatment, or healing process
- Participation in a study of another device or drug within 1 month prior to study enrollment
- Tattoos in the treatment area.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RF and PEMF therapy
Each subject is to receive 8 weekly study treatments.
The study treatment consists of Glide (medical grade glycerin) being applied thoroughly to the study treatment area (face).
The energy will be delivered by the Diamondpolar applicator attached to the Venus Versa, a medical device approved by health regulatory authorities, to deliver combined radiofrequency (RF) and pulsed electromagnetic field (PEMF) energies.
Change in skin elasticity will be measured by Cutometer.
Change in appearance will be assessed by independent reviewer using photographs.
|
Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.
Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Facial Skin Elasticity
Time Frame: 20 weeks after the last study treatment
|
A Cutometer® will be used to measure the change in gross elasticity (R2) of the facial skin as calculated by Ua/Uf which is a ratio of maximum recovery (Ua) and skin distensibility (Uf).
The value is expressed as a percentage, the closer the value is to 1 (100%), the more elastic the skin.
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20 weeks after the last study treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale
Time Frame: 7 weeks and 20 weeks post study treatments
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Subject will assign a score that best represents the level of satisfaction they have in their appearance as a result of the study treatment.
The scale reports five categories - 4 - very satisfied; 3 - satisfied; 2 - having no opinion; 1 - unsatisfied and 0 - very unsatisfied.
The higher the score, the more satisfaction with the treatment that a subject reports.
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7 weeks and 20 weeks post study treatments
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General Aesthetic Improvement Scale (GAIS)
Time Frame: 7 weeks and 20 weeks post study treatments.
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Subject to assess their general improvement in appearance at 7 and 20 weeks post-intervention using a 7 category scale: 3 - very much improved; 2 - much improved; 1 - improved; 0 - no change; -1 - worse; -2 - much worse and -3 very much worse.
The higher the positive score, the more the subject feels their appearance has changed for the better.
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7 weeks and 20 weeks post study treatments.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2016
Primary Completion (Actual)
September 29, 2017
Study Completion (Actual)
September 29, 2017
Study Registration Dates
First Submitted
November 24, 2016
First Submitted That Met QC Criteria
December 20, 2016
First Posted (Estimate)
December 23, 2016
Study Record Updates
Last Update Posted (Actual)
April 27, 2020
Last Update Submitted That Met QC Criteria
April 14, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS0316
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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