Acne Vulgaris
Conditions
Keywords
Acne
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
Interventions
DEVICEVenus Versa
Sponsors
Venus Concept
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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'. |
| 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 |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Eight patients signed the consent form but did not meet inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Pregnancy | 0 | 1 |
Baseline characteristics
| Characteristic | AC Dual Applicator | Diamondpolar Applicator, AC Dual Applicator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 20 Participants | 39 Participants |
| Baseline Inflammatory and Non-inflammatory Lesions Inflammatory Lesions | 6.95 Lesions STANDARD_DEVIATION 4.24 | 7.25 Lesions STANDARD_DEVIATION 5.3 | 7.10 Lesions STANDARD_DEVIATION 4.78 |
| Baseline Inflammatory and Non-inflammatory Lesions Non-inflammatory Lesions | 11.05 Lesions STANDARD_DEVIATION 6.96 | 13.9 Lesions STANDARD_DEVIATION 8.18 | 12.51 Lesions STANDARD_DEVIATION 7.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 17 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 2 / 20 | 2 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
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.
Time frame: Week 10 (6 weeks after last treatment)
Population: This primary outcome measurement will not be evaluated as data was not collected.
Secondary
Reduction of Inflammatory Lesions and Non-inflammatory Lesions
Reduction in the number of inflammatory lesions and non-inflammatory lesions counted on treatment area
Time frame: Week 10 (6 weeks after last treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diamondpolar Applicator, AC Dual Applicator | Reduction of Inflammatory Lesions and Non-inflammatory Lesions | Inflammatory Lesions | 4.03 Lesions | Standard Deviation 3.59 |
| Diamondpolar Applicator, AC Dual Applicator | Reduction of Inflammatory Lesions and Non-inflammatory Lesions | Non-inflammatory Lesions | 7.29 Lesions | Standard Deviation 5.3 |
| AC Dual Applicator | Reduction of Inflammatory Lesions and Non-inflammatory Lesions | Inflammatory Lesions | 5.13 Lesions | Standard Deviation 5.77 |
| AC Dual Applicator | Reduction of Inflammatory Lesions and Non-inflammatory Lesions | Non-inflammatory Lesions | 7.73 Lesions | Standard Deviation 8.17 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diamondpolar Applicator, AC Dual Applicator | Subject Assessment of Improvement in Acne Related 'Quality of Life' | 90.9 score on a scale | Standard Deviation 29.12 |
| AC Dual Applicator | Subject Assessment of Improvement in Acne Related 'Quality of Life' | 85.47 score on a scale | Standard Deviation 31.92 |
Secondary
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.
Time frame: Week 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diamondpolar Applicator, AC Dual Applicator | Subject Assessment of Improvement in 'Quality of Life' | 113.29 score on a scale | Standard Deviation 24.36 |
| AC Dual Applicator | Subject Assessment of Improvement in 'Quality of Life' | 107.27 score on a scale | Standard Deviation 32.84 |
Secondary
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'.
Time frame: Immediately after each applicator treatment at Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diamondpolar Applicator, AC Dual Applicator | Subject Assessment of Pain and Discomfort Associated With Treatments | 1.85 units on a scale | Standard Deviation 1.68 |
| AC Dual Applicator | Subject Assessment of Pain and Discomfort Associated With Treatments | 2.53 units on a scale | Standard Deviation 1.41 |
Secondary
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'.
Time frame: Immediately after each applicator treatment at Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diamondpolar Applicator, AC Dual Applicator | Subject Assessment of Pain and Discomfort Associated With Treatments | 2.30 units on a scale | Standard Deviation 2.17 |
| AC Dual Applicator | Subject Assessment of Pain and Discomfort Associated With Treatments | 2.45 units on a scale | Standard Deviation 1.6 |
Secondary
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.
Time frame: Week 10 (6 weeks after last treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diamondpolar Applicator, AC Dual Applicator | Subject Improvement Assessment in Treatment Area Appearance | Much Worse (-2) | 1 Participants |
| Diamondpolar Applicator, AC Dual Applicator | Subject Improvement Assessment in Treatment Area Appearance | Improved (1) | 10 Participants |
| Diamondpolar Applicator, AC Dual Applicator | Subject Improvement Assessment in Treatment Area Appearance | Much Improved (2) | 4 Participants |
| Diamondpolar Applicator, AC Dual Applicator | Subject Improvement Assessment in Treatment Area Appearance | No Change (0) | 3 Participants |
| AC Dual Applicator | Subject Improvement Assessment in Treatment Area Appearance | Much Improved (2) | 6 Participants |
| AC Dual Applicator | Subject Improvement Assessment in Treatment Area Appearance | Much Worse (-2) | 0 Participants |
| AC Dual Applicator | Subject Improvement Assessment in Treatment Area Appearance | No Change (0) | 2 Participants |
| AC Dual Applicator | Subject Improvement Assessment in Treatment Area Appearance | Improved (1) | 9 Participants |
Secondary
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.
Time frame: Week 10 (6 weeks after last treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diamondpolar Applicator, AC Dual Applicator | Subject Satisfaction With Treatment Outcome | Unsatisfied (1) | 2 Participants |
| Diamondpolar Applicator, AC Dual Applicator | Subject Satisfaction With Treatment Outcome | Satisfied (3) | 9 Participants |
| Diamondpolar Applicator, AC Dual Applicator | Subject Satisfaction With Treatment Outcome | Having No Opinion (2) | 2 Participants |
| Diamondpolar Applicator, AC Dual Applicator | Subject Satisfaction With Treatment Outcome | Very Satisfied (4) | 5 Participants |
| Diamondpolar Applicator, AC Dual Applicator | Subject Satisfaction With Treatment Outcome | Very Unsatisfied (0) | 0 Participants |
| AC Dual Applicator | Subject Satisfaction With Treatment Outcome | Very Satisfied (4) | 5 Participants |
| AC Dual Applicator | Subject Satisfaction With Treatment Outcome | Very Unsatisfied (0) | 1 Participants |
| AC Dual Applicator | Subject Satisfaction With Treatment Outcome | Unsatisfied (1) | 0 Participants |
| AC Dual Applicator | Subject Satisfaction With Treatment Outcome | Having No Opinion (2) | 4 Participants |
| AC Dual Applicator | Subject Satisfaction With Treatment Outcome | Satisfied (3) | 7 Participants |