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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Improvement in Acne Vulgaris Appearance
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Improvement in Acne Vulgaris Appearance
时间窗: 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.
次要结局
- Subject Satisfaction With Treatment Outcome(Week 10 (6 weeks after last treatment))
- Reduction of Inflammatory Lesions and Non-inflammatory Lesions(Week 10 (6 weeks after last treatment))
- Subject Assessment of Pain and Discomfort Associated With Treatments(Immediately after each applicator treatment at Week 6)
- Subject Improvement Assessment in Treatment Area Appearance(Week 10 (6 weeks after last treatment))
- Subject Assessment of Improvement in 'Quality of Life'(Week 10)
- Subject Assessment of Improvement in Acne Related 'Quality of Life'(Baseline)