Back to resultsChange in Skin Elasticity With RF and PEMF
Primary Purpose
Skin Abnormalities
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cutometer
Photographs
Sponsored by
About this trial
This is an interventional treatment trial for Skin Abnormalities focused on measuring rhytides, wrinkle
Eligibility Criteria
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.
Sites / Locations
- Art of Facial Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RF and PEMF therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Facial Skin Elasticity
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.
Secondary Outcome Measures
Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale
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.
General Aesthetic Improvement Scale (GAIS)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03002194
Brief Title
Change in Skin Elasticity With RF and PEMF
Official Title
Change in Skin Elasticity After Combined Radiofrequency and Electromagnetic Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
September 29, 2017 (Actual)
Study Completion Date
September 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venus Concept
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will measure the difference in skin elasticity in females only before and after treatment with radiofrequency and pulsed electromagnetic field therapy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Abnormalities
Keywords
rhytides, wrinkle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RF and PEMF therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cutometer
Intervention Description
Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.
Intervention Type
Other
Intervention Name(s)
Photographs
Intervention Description
Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment.
Primary Outcome Measure Information:
Title
Change in Facial Skin Elasticity
Description
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.
Time Frame
20 weeks after the last study treatment
Secondary Outcome Measure Information:
Title
Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale
Description
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.
Time Frame
7 weeks and 20 weeks post study treatments
Title
General Aesthetic Improvement Scale (GAIS)
Description
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.
Time Frame
7 weeks and 20 weeks post study treatments.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoni Iger, PhD
Organizational Affiliation
Venus Concept Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Art of Facial Surgery
City
North York
State/Province
Ontario
ZIP/Postal Code
M2N 6H7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Change in Skin Elasticity With RF and PEMF
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