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

• ClinicalTrials.gov Identifier: NCT02924428
• Recruitment Status: Terminated
• First Posted: October 5, 2016
• Results First Posted: October 14, 2020
• Last Update Posted: November 9, 2020
• Sponsor: Venus Concept
• Information provided by (Responsible Party): Venus Concept

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acne Vulgaris
• Intervention: Device: Venus Versa
• Enrollment: 47

Participant Flow

Recruitment Details
Pre-assignment Details	Eight patients signed the consent form but did not meet inclusion/exclusion criteria.

Arm/Group Title	Diamondpolar Applicator, AC Dual Applicator	AC Dual Applicator
Arm/Group Description	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.	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.
Period Title: Overall Study
Started	20	19
Completed	16	14
Not Completed	4	5
Reason Not Completed
Adverse Event	1	0
Physician Decision	1	0
Lost to Follow-up	2	4
Pregnancy	0	1

Baseline Characteristics

Arm/Group Title		Diamondpolar Applicator, AC Dual Applicator	AC Dual Applicator	Total
Arm/Group Description		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.	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 of all reporting groups
Overall Number of Baseline Participants		20	19	39
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	19 participants	39 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	20 100.0%	19 100.0%	39 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	19 participants	39 participants
	Female	18 90.0%	15 78.9%	33 84.6%
	Male	2 10.0%	4 21.1%	6 15.4%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	19 participants	39 participants
	Hispanic or Latino	3 15.0%	5 26.3%	8 20.5%
	Not Hispanic or Latino	17 85.0%	14 73.7%	31 79.5%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	19 participants	39 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	3 15.0%	3 15.8%	6 15.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	3 15.0%	2 10.5%	5 12.8%
	White	14 70.0%	13 68.4%	27 69.2%
	More than one race	0 0.0%	1 5.3%	1 2.6%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Baseline Inflammatory and Non-inflammatory Lesions [1]; Mean (Standard Deviation); Unit of measure: Lesions	Number Analyzed	20 participants	19 participants	39 participants
Inflammatory Lesions		7.25 (5.30)	6.95 (4.24)	7.10 (4.78)
Non-inflammatory Lesions		13.9 (8.18)	11.05 (6.96)	12.51 (7.69)
		[1] Measure Description: Average baseline count of number of inflammatory and non-inflammatory acne lesions per treatment group.

Outcome Measures

1. Primary Outcome

Title	Improvement in Acne Vulgaris Appearance
Description	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.
Time Frame	Week 10 (6 weeks after last treatment)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Diamondpolar Applicator, AC Dual Applicator	AC Dual Applicator
Arm/Group Description:	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.	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 Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

2. Secondary Outcome

Title	Reduction of Inflammatory Lesions and Non-inflammatory Lesions
Description	Reduction in the number of inflammatory lesions and non-inflammatory lesions counted on treatment area
Time Frame	Week 10 (6 weeks after last treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diamondpolar Applicator, AC Dual Applicator	AC Dual Applicator
Arm/Group Description:	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.	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 Number of Participants Analyzed	17	15
Mean (Standard Deviation); Unit of Measure: Lesions
Inflammatory Lesions	4.03 (3.59)	5.13 (5.77)
Non-inflammatory Lesions	7.29 (5.30)	7.73 (8.17)

3. Secondary Outcome

Title	Subject Improvement Assessment in Treatment Area Appearance
Description	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.
Time Frame	Week 10 (6 weeks after last treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diamondpolar Applicator, AC Dual Applicator	AC Dual Applicator
Arm/Group Description:	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.	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 Number of Participants Analyzed	18	17
Measure Type: Count of Participants; Unit of Measure: Participants
Much Worse (-2)	1 5.6%	0 0.0%
No Change (0)	3 16.7%	2 11.8%
Improved (1)	10 55.6%	9 52.9%
Much Improved (2)	4 22.2%	6 35.3%

4. Secondary Outcome

Title	Subject Assessment of Pain and Discomfort Associated With Treatments
Description	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'.
Time Frame	Immediately after each applicator treatment at Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diamondpolar Applicator, AC Dual Applicator	AC Dual Applicator
Arm/Group Description:	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.	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 Number of Participants Analyzed	18	19
Mean (Standard Deviation); Unit of Measure: units on a scale
	1.85 (1.68)	2.53 (1.41)

5. Secondary Outcome

Title	Subject Satisfaction With Treatment Outcome
Description	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.
Time Frame	Week 10 (6 weeks after last treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diamondpolar Applicator, AC Dual Applicator	AC Dual Applicator
Arm/Group Description:	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.	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 Number of Participants Analyzed	18	17
Measure Type: Count of Participants; Unit of Measure: Participants
Very Unsatisfied (0)	0 0.0%	1 5.9%
Unsatisfied (1)	2 11.1%	0 0.0%
Having No Opinion (2)	2 11.1%	4 23.5%
Satisfied (3)	9 50.0%	7 41.2%
Very Satisfied (4)	5 27.8%	5 29.4%

6. Secondary Outcome

Title	Subject Assessment of Improvement in Acne Related 'Quality of Life'
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diamondpolar Applicator, AC Dual Applicator	AC Dual Applicator
Arm/Group Description:	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.	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 Number of Participants Analyzed	20	19
Mean (Standard Deviation); Unit of Measure: score on a scale
	90.9 (29.12)	85.47 (31.92)

7. Secondary Outcome

Title	Subject Assessment of Pain and Discomfort Associated With Treatments
Description	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'.
Time Frame	Immediately after each applicator treatment at Week 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diamondpolar Applicator, AC Dual Applicator	AC Dual Applicator
Arm/Group Description:	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.	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 Number of Participants Analyzed	16	16
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.30 (2.17)	2.45 (1.60)

8. Secondary Outcome

Title	Subject Assessment of Improvement in 'Quality of Life'
Description	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.
Time Frame	Week 10

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diamondpolar Applicator, AC Dual Applicator	AC Dual Applicator
Arm/Group Description:	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.	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 Number of Participants Analyzed	17	15
Mean (Standard Deviation); Unit of Measure: score on a scale
	113.29 (24.36)	107.27 (32.84)

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Diamondpolar Applicator, AC Dual Applicator		AC Dual Applicator
Arm/Group Description	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.		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.
All-Cause Mortality
	Diamondpolar Applicator, AC Dual Applicator		AC Dual Applicator
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/20 (0.00%)		0/19 (0.00%)
Serious Adverse Events
	Diamondpolar Applicator, AC Dual Applicator		AC Dual Applicator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0.00%)		0/19 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Diamondpolar Applicator, AC Dual Applicator		AC Dual Applicator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10.00%)		2/19 (10.53%)
Skin and subcutaneous tissue disorders
Skin Hypopigmentation * 1 [1]	1/20 (5.00%)	1	0/19 (0.00%)	0
Thermal burn * 1	1/20 (5.00%)	1	2/19 (10.53%)	2
1 Term from vocabulary, MedDRA (21.0); * Indicates events were collected by non-systematic assessment; [1] Subject did not complete the study as developed skin hypopigmentation post treatment.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Director, Clinical Affairs
• Organization: Venus Concept Ltd.
• Phone: 416-222-6144 ext 517
• EMail: mgronski@venusconcept.com

• Responsible Party: Venus Concept
• ClinicalTrials.gov Identifier: NCT02924428
• Other Study ID Numbers: CS2715
• First Submitted: September 30, 2016
• First Posted: October 5, 2016
• Results First Submitted: August 25, 2020
• Results First Posted: October 14, 2020
• Last Update Posted: November 9, 2020