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

• Sponsor: Venus Concept (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02924428
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the efficacy of facial acne vulgaris treatment using the Venus Versa Diamondpolar applicator in combination with the Venus Versa AC dual applicator using two intense pulsed light wavelength bands.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Device: Venus Versa	N/A

Detailed Description

Multi-center, prospective, open-label study utilizing before-after study design. Up to 20 healthy subjects, age 18 - 55 years with acne vulgaris who wish to improve their skin appearance will be randomized to receive either Diamondpolar applicator (radio frequency and pulsed magnetic field) treatment followed by AC Dual applicator (intense pulsed light) treatment or AC Dual applicator (intense pulsed light) treatment alone using the Venus Versa system. Duration of subject participation will be approximately 10 weeks (4 weekly treatments with a follow-up visit scheduled 6 weeks after the last treatment).

The AC Dual applicator (IPL) is indicated for the treatment of acne vulgaris by using a blue light (415 nm) to target porphyrins produced by the P. acne bacteria, destroying the bacteria and uses the red light (630 nm) to help reduce inflammation, inhibit sebum production and improve healing.

The addition of the Diamondpolar applicator (RF and PEMF) treatment is thought to target the sebaceous gland, causing it to shrink and decrease sebum output

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Venus Versa Diamonpolar Applicator Treatment Followed by AC Dual Applicator Treatment Using 2 Intense Pulsed Light Wavelength Bands for Facial Acne Vulgaris
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jun 5, 2018
• Actual Study Completion Date: Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Venus Versa
Active Comparator: AC Dual applicator treatment 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.	Device: Venus Versa

Outcome Measures

Primary Outcome Measures

1. Improvement in Acne Vulgaris Appearance [Week 10 (6 weeks after last treatment)]

   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.

Secondary Outcome Measures

1. Reduction of Inflammatory Lesions and Non-inflammatory Lesions [Week 10 (6 weeks after last treatment)]

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

2. Subject Improvement Assessment in Treatment Area Appearance [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.

3. Subject Assessment of Pain and Discomfort Associated With Treatments [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'.

4. Subject Satisfaction With Treatment Outcome [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.

5. Subject Assessment of Improvement in Acne Related 'Quality of Life' [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.

6. Subject Assessment of Pain and Discomfort Associated With Treatments [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'.

7. Subject Assessment of Improvement in 'Quality of Life' [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Fitzpatrick skin phototype I - VI

• Having mild to moderate acne vulgaris (as defined by the Acne Global Severity Scale) and have at least 10 inflammatory and 15 non-inflammatory lesions, but no nodulo-cystic lesions.

• Subject who can commit to all treatments and follow up.

Exclusion Criteria:

• Superficial metal or other implants in the treatment area.

• Current or history of cancer, or current condition of any type of cancer, or pre-malignant moles.

• Pregnancy and nursing.

• Patients with cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc)

• Diseases which may be stimulated by light at the wavelengths used, such as history of Systemic Lupus Erythematosus, Porphyria, and Epilepsy.

• Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.

• Poorly controlled endocrine disorders, such as Diabetes or Polycystic Ovary Syndrome.

• Any active condition in the treatment area, such as sores, Psoriasis, eczema, and rash.

• Tattoos, scars or piercings in the treated area.

• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.

• Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelengths used, such as Isotretinoin (Accutane) within the last six months, tetracyclines, or St. John's Wort within the last two weeks.

• Any surgical procedure in the treatment area within the last three months or before complete healing.

• Treating over tattoo or permanent makeup.

• Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.

• As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

• Exposure to investigational product within 3 months (or designated half-life) prior to enrollment.

• Prior drugs, interventions, skin laser/light or another device for Acne treatment within 3 months of initial treatment or during the course of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sadick Research Group	New York	New York	United States	10075

Sponsors and Collaborators

• Venus Concept

Investigators

• Study Director: Joseph L Reiz, Venus Concept Ltd.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 4, 2017

More Information

Publications

None provided.

• Responsible Party: Venus Concept
• ClinicalTrials.gov Identifier: NCT02924428
• Other Study ID Numbers: CS2715
• First Posted: Oct 5, 2016
• Last Update Posted: Nov 9, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Venus Concept: Acne
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Pre-assignment Detail	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

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 Participants	20	19	39
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	19 100%	39 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	18 90%	15 78.9%	33 84.6%
Male	2 10%	4 21.1%	6 15.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 15%	5 26.3%	8 20.5%
Not Hispanic or Latino	17 85%	14 73.7%	31 79.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 15%	3 15.8%	6 15.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 15%	2 10.5%	5 12.8%
White	14 70%	13 68.4%	27 69.2%
More than one race	0 0%	1 5.3%	1 2.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Baseline Inflammatory and Non-inflammatory Lesions (Lesions) [Mean (Standard Deviation) ]
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)

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.
Measure Participants	0	0

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.
Measure Participants	17	15
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.
Measure Participants	18	17
Much Worse (-2)	1 5%	0 0%
No Change (0)	3 15%	2 10.5%
Improved (1)	10 50%	9 47.4%
Much Improved (2)	4 20%	6 31.6%

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.
Measure Participants	18	19
Mean (Standard Deviation) [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.
Measure Participants	18	17
Very Unsatisfied (0)	0 0%	1 5.3%
Unsatisfied (1)	2 10%	0 0%
Having No Opinion (2)	2 10%	4 21.1%
Satisfied (3)	9 45%	7 36.8%
Very Satisfied (4)	5 25%	5 26.3%

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.
Measure Participants	20	19
Mean (Standard Deviation) [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.
Measure Participants	16	16
Mean (Standard Deviation) [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.
Measure Participants	17	15
Mean (Standard Deviation) [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.
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)
Serious Adverse Events
	Diamondpolar Applicator, AC Dual Applicator		AC Dual Applicator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Diamondpolar Applicator, AC Dual Applicator		AC Dual Applicator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		2/19 (10.5%)
Skin and subcutaneous tissue disorders
Skin Hypopigmentation	1/20 (5%)	1	0/19 (0%)	0
Thermal burn	1/20 (5%)	1	2/19 (10.5%)	2

Limitations/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.