Back to resultsVenus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Venus Versa
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne
Eligibility Criteria
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.
Sites / Locations
- Sadick Research Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diamondpolar applicator, AC Dual applicator
AC Dual applicator treatment
Arm 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.
Outcomes
Primary Outcome Measures
Improvement in Acne Vulgaris Appearance
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
Reduction of Inflammatory Lesions and Non-inflammatory Lesions
Reduction in the number of inflammatory lesions and non-inflammatory lesions counted on treatment area
Subject Improvement Assessment in Treatment Area Appearance
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.
Subject Assessment of Pain and Discomfort Associated With Treatments
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'.
Subject Satisfaction With Treatment Outcome
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.
Subject Assessment of Improvement in Acne Related 'Quality of Life'
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.
Subject Assessment of Pain and Discomfort Associated With Treatments
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'.
Subject Assessment of Improvement in 'Quality of Life'
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02924428
Brief Title
Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris
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 Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
not commenced
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venus Concept
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diamondpolar applicator, AC Dual applicator
Arm Type
Experimental
Arm 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.
Arm Title
AC Dual applicator treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Venus Versa
Primary Outcome Measure Information:
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)
Secondary Outcome Measure Information:
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)
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)
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
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)
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph L Reiz
Organizational Affiliation
Venus Concept Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris
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