Trial Outcomes & Findings for Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris (NCT NCT02924428)

Last Updated: 2020-11-09

Results Overview

Treatment will be considered successful if the appearance improves by at least 2 points on the 5-point Global Acne Assessment Score (GAAS) at 6 weeks post treatment as compared to baseline where 0 = No evidence of facial acne vulgaris, 1 (minimal) = Few non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) may be present, 2 (mild) = Several to many non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present, 3 (Moderate) = Many non-inflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed, 4 (Severe) = Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present. Lower number represents an improvement in acne vulgaris.

Recruitment status

TERMINATED

Study phase

Target enrollment

47 participants

Primary outcome timeframe

Week 10 (6 weeks after last treatment)

Results posted on

2020-11-09

Participant Flow

Eight patients signed the consent form but did not meet inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	Diamondpolar Applicator, AC Dual Applicator Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.	AC Dual Applicator Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.
Overall Study STARTED	20	19
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Diamondpolar Applicator, AC Dual Applicator Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.	AC Dual Applicator Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.
Overall Study Adverse Event	1	0
Overall Study Physician Decision	1	0
Overall Study Lost to Follow-up	2	4
Overall Study Pregnancy	0	1

Baseline Characteristics

Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diamondpolar Applicator, AC Dual Applicator n=20 Participants Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.	AC Dual Applicator n=19 Participants Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Inflammatory and Non-inflammatory Lesions Inflammatory Lesions	7.25 Lesions STANDARD_DEVIATION 5.30 • n=5 Participants	6.95 Lesions STANDARD_DEVIATION 4.24 • n=7 Participants	7.10 Lesions STANDARD_DEVIATION 4.78 • n=5 Participants
Baseline Inflammatory and Non-inflammatory Lesions Non-inflammatory Lesions	13.9 Lesions STANDARD_DEVIATION 8.18 • n=5 Participants	11.05 Lesions STANDARD_DEVIATION 6.96 • n=7 Participants	12.51 Lesions STANDARD_DEVIATION 7.69 • n=5 Participants

PRIMARY outcome

Timeframe: Week 10 (6 weeks after last treatment)

Population: This primary outcome measurement will not be evaluated as data was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 10 (6 weeks after last treatment)

Reduction in the number of inflammatory lesions and non-inflammatory lesions counted on treatment area

Outcome measures

Outcome measures
Measure	Diamondpolar Applicator, AC Dual Applicator n=17 Participants Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.	AC Dual Applicator n=15 Participants Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.
Reduction of Inflammatory Lesions and Non-inflammatory Lesions Inflammatory Lesions	4.03 Lesions Standard Deviation 3.59	5.13 Lesions Standard Deviation 5.77
Reduction of Inflammatory Lesions and Non-inflammatory Lesions Non-inflammatory Lesions	7.29 Lesions Standard Deviation 5.30	7.73 Lesions Standard Deviation 8.17

SECONDARY outcome

Timeframe: Week 10 (6 weeks after last treatment)

Improvement as evaluated by subject using the Global Aesthetic Improvement Scale (GAIS) at 6 weeks after last treatment as compared to baseline where 3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse, -2 = Much Worse and -3 = Very Much Worse.

Outcome measures

Outcome measures
Measure	Diamondpolar Applicator, AC Dual Applicator n=18 Participants Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.	AC Dual Applicator n=17 Participants Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.
Subject Improvement Assessment in Treatment Area Appearance Much Improved (2)	4 Participants	6 Participants
Subject Improvement Assessment in Treatment Area Appearance Much Worse (-2)	1 Participants	0 Participants
Subject Improvement Assessment in Treatment Area Appearance No Change (0)	3 Participants	2 Participants
Subject Improvement Assessment in Treatment Area Appearance Improved (1)	10 Participants	9 Participants

SECONDARY outcome

Timeframe: Immediately after each applicator treatment at Week 1

Pain and discomfort evaluated by subject using the 10 cm Visual Analog Scale where 0 cm is 'no pain' and 10 cm is 'intolerable pain'.

Outcome measures

Outcome measures
Measure	Diamondpolar Applicator, AC Dual Applicator n=18 Participants Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.	AC Dual Applicator n=19 Participants Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.
Subject Assessment of Pain and Discomfort Associated With Treatments	1.85 units on a scale Standard Deviation 1.68	2.53 units on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: Week 10 (6 weeks after last treatment)

Satisfaction evaluated by subject using a 5-point Likert Scale where 4 = Very Satisfied, 3 = Satisfied, 2 Having No Opinion, 1 = Unsatisfied and 0 = Very Unsatisfied.

Outcome measures

Outcome measures
Measure	Diamondpolar Applicator, AC Dual Applicator n=18 Participants Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.	AC Dual Applicator n=17 Participants Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.
Subject Satisfaction With Treatment Outcome Very Satisfied (4)	5 Participants	5 Participants
Subject Satisfaction With Treatment Outcome Very Unsatisfied (0)	0 Participants	1 Participants
Subject Satisfaction With Treatment Outcome Unsatisfied (1)	2 Participants	0 Participants
Subject Satisfaction With Treatment Outcome Having No Opinion (2)	2 Participants	4 Participants
Subject Satisfaction With Treatment Outcome Satisfied (3)	9 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline

Subject evaluated quality of life measured with the Acne Related Quality of Life Questionnaire at baseline where the total score varies from 0 to 114 with higher scores reflecting better quality of life.

Outcome measures

Outcome measures
Measure	Diamondpolar Applicator, AC Dual Applicator n=20 Participants Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.	AC Dual Applicator n=19 Participants Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.
Subject Assessment of Improvement in Acne Related 'Quality of Life'	90.9 score on a scale Standard Deviation 29.12	85.47 score on a scale Standard Deviation 31.92

SECONDARY outcome

Timeframe: Immediately after each applicator treatment at Week 6

Pain and discomfort evaluated by subject using the 10 cm Visual Analog Scale where 0 cm is 'no pain' and 10 cm is 'intolerable pain'.

Outcome measures

Outcome measures
Measure	Diamondpolar Applicator, AC Dual Applicator n=16 Participants Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.	AC Dual Applicator n=16 Participants Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.
Subject Assessment of Pain and Discomfort Associated With Treatments	2.30 units on a scale Standard Deviation 2.17	2.45 units on a scale Standard Deviation 1.60

SECONDARY outcome

Timeframe: Week 10

Subject evaluated quality of life measured with the Acne Related Quality of Life Questionnaire at week 10 where the total score varies from 0 to 114 with higher scores reflecting better quality of life.

Outcome measures

Outcome measures
Measure	Diamondpolar Applicator, AC Dual Applicator n=17 Participants Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.	AC Dual Applicator n=15 Participants Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.
Subject Assessment of Improvement in 'Quality of Life'	113.29 score on a scale Standard Deviation 24.36	107.27 score on a scale Standard Deviation 32.84

Adverse Events

Diamondpolar Applicator, AC Dual Applicator

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

AC Dual Applicator

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diamondpolar Applicator, AC Dual Applicator n=20 participants at risk Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.	AC Dual Applicator n=19 participants at risk Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.
Skin and subcutaneous tissue disorders Skin Hypopigmentation	5.0% 1/20 • Number of events 1 • Adverse event data were collected from time after informed consent was obtained until 7 days (for non-serious adverse events) and 30 days for serious adverse events after the last day of study participation, approximately 11 weeks for non-serious adverse events and 14 weeks for serious adverse events.	0.00% 0/19 • Adverse event data were collected from time after informed consent was obtained until 7 days (for non-serious adverse events) and 30 days for serious adverse events after the last day of study participation, approximately 11 weeks for non-serious adverse events and 14 weeks for serious adverse events.
Skin and subcutaneous tissue disorders Thermal burn	5.0% 1/20 • Number of events 1 • Adverse event data were collected from time after informed consent was obtained until 7 days (for non-serious adverse events) and 30 days for serious adverse events after the last day of study participation, approximately 11 weeks for non-serious adverse events and 14 weeks for serious adverse events.	10.5% 2/19 • Number of events 2 • Adverse event data were collected from time after informed consent was obtained until 7 days (for non-serious adverse events) and 30 days for serious adverse events after the last day of study participation, approximately 11 weeks for non-serious adverse events and 14 weeks for serious adverse events.

Additional Information

Director, Clinical Affairs

Venus Concept Ltd.

Phone: 416-222-6144

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place