Clinical trial NCT02924428: 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
Overall status: TERMINATED
Phase: NA
Conditions: Acne Vulgaris
Keywords: Acne
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Improvement in Acne Vulgaris Appearance
timeFrame: Week 10 (6 weeks after last treatment)
Secondary outcomes:
measure: Reduction of Inflammatory Lesions and Non-inflammatory Lesions
timeFrame: Week 10 (6 weeks after last treatment)
measure: Subject Improvement Assessment in Treatment Area Appearance
timeFrame: Week 10 (6 weeks after last treatment)
measure: Subject Assessment of Pain and Discomfort Associated With Treatments
timeFrame: Immediately after each applicator treatment at Week 1
measure: Subject Satisfaction With Treatment Outcome
timeFrame: Week 10 (6 weeks after last treatment)
measure: Subject Assessment of Improvement in Acne Related 'Quality of Life'
timeFrame: Baseline
measure: Subject Assessment of Pain and Discomfort Associated With Treatments
timeFrame: Immediately after each applicator treatment at Week 6
measure: Subject Assessment of Improvement in 'Quality of Life'
timeFrame: Week 10
Other outcomes:
Locations:
city: New York
country: United States
facility: Sadick Research Group
state: New York
Study officials:
affiliation: Venus Concept Ltd.
name: Joseph L Reiz
role: STUDY_DIRECTOR
References: