Trial Outcomes & Findings for Change in Skin Elasticity With RF and PEMF (NCT NCT03002194)

Last Updated: 2020-04-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

20 weeks after the last study treatment

Results posted on

2020-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	48
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	6
Overall Study Adverse Event	1
Overall Study Lack of Efficacy	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Change in Skin Elasticity With RF and PEMF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=48 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex/Gender, Customized Female	48 participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment Canada	48 participants n=5 Participants
Baseline cutometer reading	0.7658 ratio STANDARD_DEVIATION 0.1127 • n=5 Participants

PRIMARY outcome

Timeframe: 20 weeks after the last study treatment

Outcome measures

Outcome measures
Measure	RF and PEMF Therapy n=38 Participants 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.
Change in Facial Skin Elasticity Mean R2 Cutometer Reading Baseline	0.7658 ratio Standard Deviation 0.1127
Change in Facial Skin Elasticity Mean R2 Cutometer Reading Wk 20	0.7244 ratio Standard Deviation 0.1487

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	RF and PEMF Therapy n=38 Participants 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.
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
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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	RF and PEMF Therapy n=38 Participants 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.
General Aesthetic Improvement Scale (GAIS) Mean GAIS week 7 post Tx	1.19 score on a scale Standard Deviation 0.92
General Aesthetic Improvement Scale (GAIS) Mean GAIS week 20 post Tx	0.58 score on a scale Standard Deviation 0.74

Adverse Events

RF and PEMF Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yoni Iger

Venus Concept Ltd

Phone: 888-907-0115

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place