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

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ClinicalTrials.gov Identifier: NCT02924428
Recruitment Status : Terminated (not commenced)
First Posted : October 5, 2016
Results First Posted : October 14, 2020
Last Update Posted : November 9, 2020
Sponsor:
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
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
Hide 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
Arm/Group Title Diamondpolar Applicator, AC Dual Applicator AC Dual Applicator Total
Hide 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
Hide 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.
1.Primary Outcome
Title Improvement in Acne Vulgaris Appearance
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diamondpolar Applicator, AC Dual Applicator AC Dual Applicator
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diamondpolar Applicator, AC Dual Applicator AC Dual Applicator
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diamondpolar Applicator, AC Dual Applicator AC Dual Applicator
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diamondpolar Applicator, AC Dual Applicator AC Dual Applicator
Hide 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'
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diamondpolar Applicator, AC Dual Applicator AC Dual Applicator
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diamondpolar Applicator, AC Dual Applicator AC Dual Applicator
Hide 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'
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diamondpolar Applicator, AC Dual Applicator AC Dual Applicator
Hide 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)
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
Hide 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%)    
Hide 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%)    
Hide 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.
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
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Affairs
Organization: Venus Concept Ltd.
Phone: 416-222-6144 ext 517
EMail: mgronski@venusconcept.com
Layout table for additonal information
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