Skin Abnormalities
Conditions
Keywords
rhytides, wrinkle
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.
Interventions
DEVICECutometer
Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.
OTHERPhotographs
Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment.
Sponsors
Venus Concept
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Facial Skin Elasticity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale | 7 weeks and 20 weeks post study treatments | 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) | 7 weeks and 20 weeks post study treatments. | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group 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. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Baseline cutometer reading | 0.7658 ratio STANDARD_DEVIATION 0.1127 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 43 Participants |
| Region of Enrollment Canada | 48 participants |
| Sex/Gender, Customized Female | 48 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
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.
Time frame: 20 weeks after the last study treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RF and PEMF Therapy | Change in Facial Skin Elasticity | Mean R2 Cutometer Reading Baseline | 0.7658 ratio | Standard Deviation 0.1127 |
| RF and PEMF Therapy | Change in Facial Skin Elasticity | Mean R2 Cutometer Reading Wk 20 | 0.7244 ratio | Standard Deviation 0.1487 |
Secondary
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.
Time frame: 7 weeks and 20 weeks post study treatments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RF and PEMF Therapy | General Aesthetic Improvement Scale (GAIS) | Mean GAIS week 7 post Tx | 1.19 score on a scale | Standard Deviation 0.92 |
| RF and PEMF Therapy | General Aesthetic Improvement Scale (GAIS) | Mean GAIS week 20 post Tx | 0.58 score on a scale | Standard Deviation 0.74 |
Secondary
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.
Time frame: 7 weeks and 20 weeks post study treatments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RF and PEMF Therapy | Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale | Mean Satisfaction week 7 post Tx | 3.11 score on a scale | Standard Deviation 0.92 |
| RF and PEMF Therapy | Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale | Mean Satisfaction Week 20 post Tx | 2.58 score on a scale | Standard Deviation 1.12 |