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

Tracking Information

• First Submitted Date: September 30, 2016
• First Posted Date: October 5, 2016
• Results First Submitted Date: August 25, 2020
• Results First Posted Date: October 14, 2020
• Last Update Posted Date: November 9, 2020
• Study Start Date: September 2016
• Actual Primary Completion Date: June 5, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 18, 2020)

Improvement in Acne Vulgaris Appearance [ Time Frame: 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.

Original Primary Outcome Measures (submitted: October 3, 2016)

Improvement in treatment area appearance as determined by a blinded reviewer. [ Time Frame: 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 as compared to baseline.

Current Secondary Outcome Measures (submitted: September 18, 2020)

• Reduction of Inflammatory Lesions and Non-inflammatory Lesions [ Time Frame: Week 10 (6 weeks after last treatment) ]
  Reduction in the number of inflammatory lesions and non-inflammatory lesions counted on treatment area
• Subject Improvement Assessment in Treatment Area Appearance [ Time Frame: 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 [ Time Frame: 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'.
• Subject Satisfaction With Treatment Outcome [ Time Frame: 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.
• Subject Assessment of Improvement in Acne Related 'Quality of Life' [ Time Frame: 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 Pain and Discomfort Associated With Treatments [ Time Frame: 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'.
• Subject Assessment of Improvement in 'Quality of Life' [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: October 3, 2016)

• Reduction of inflammatory lesions and non-inflammatory lesions [ Time Frame: Week 10 (6 weeks after last treatment) ]
• Subject improvement assessment in treatment area appearance [ Time Frame: Week 10 (6 weeks after last treatment) ]
  Improvement evaluated by Global Aesthetic Improvement Scale (GAIS) at 6 weeks after last treatment as compared to baseline.
• Subject assessment of pain and discomfort associated with treatments [ Time Frame: Week 1, 2, 3 and 4 (immediately after each applicator treatment completed) ]
  Pain and discomfort evaluated by subject using the 100 mm Visual Analog Scale where 0 mm is 'no pain' and 100 mm is 'intolerable pain'.
• Subject satisfaction with treatment outcome [ Time Frame: Week 10 (6 weeks after last treatment) ]
  Satisfaction evaluated by subject using a 5-point Likert Scale.
• Subject assessment of improvement in 'quality of life' [ Time Frame: Week 1, 2, 3 and 4 and week 10 ]
  Quality of life questionnaire

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acne Vulgaris
• Intervention: Device: Venus Versa

Study Arms

• 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.

  Intervention: 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.

  Intervention: Device: Venus Versa

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 18, 2020): 47
• Original Estimated Enrollment (submitted: October 3, 2016): 20
• Actual Study Completion Date: October 2018
• Actual Primary Completion Date: June 5, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02924428
• Other Study ID Numbers: CS2715
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Venus Concept
• Original Responsible Party: Same as current
• Current Study Sponsor: Venus Concept
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Venus Concept
• Verification Date: October 2020