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This study will measure the difference in skin elasticity in females only before and after treatment with radiofrequency and pulsed electromagnetic field therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RF and PEMF therapy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutometer | Device | Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 weeks after the last study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoni Iger, PhD | Venus Concept Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Art of Facial Surgery | North York | Ontario | M2N 6H7 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Cutometer: Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment. Photographs: Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | ratio | 20 weeks after the last study treatment |
|
Adverse event data was collected for 9 months and 18 days. All reportable events with start dates occurring any time after informed consent is obtained will be followed until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Cutometer: Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment. Photographs: Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoni Iger | Venus Concept Ltd | 888-907-0115 | yoni@venusconcept.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2016 | Apr 6, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015903 | Moire Topography |
| ID | Term |
|---|---|
| D010780 | Photogrammetry |
| D010781 | Photography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Photographs | Other | Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment. |
|
| 7 weeks and 20 weeks post study treatments |
| 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. | 7 weeks and 20 weeks post study treatments. |
| Withdrawal by Subject |
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| Participants |
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| Sex/Gender, Customized | Number | participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| Baseline cutometer reading | Change in skin elasticity will be measured by a Cutometer prior to beginning treatment. The ratio R2 describes the change in gross elasticity as a ratio of maximum recovery (Ua) and skin distensibility (Uf) (Ua/Uf). | Mean | Standard Deviation | ratio |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks and 20 weeks post study treatments |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks and 20 weeks post study treatments. |
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| 48 |
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| D003933 |
| Diagnosis |
| D007368 | Interferometry |
| D008919 | Investigative Techniques |