Monocenter, Randomized, Double Blinded, Intraindividual, Exploratory Study of Effectiveness and Safety of 3 Months Treatment With 2 Peak Intensities of 453nm Blue Light for the Treatment of Mild Plaque Type Psoriasis Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity (HI) Group) as Compared to the Control Area at End of Treatment (Visit 7, Week 12).
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of a blue light device for treating Psoriasis vulgaris. The study will compare a blue light treated plaque with an untreated control plaque. Additionally, two intensities of blue light are compared.
详细描述
Blue light has been shown to release bioactive nitric oxide (NO) from nitrite and nitrosated proteins found in high concentrations in the skin. This bioactive NO has many physiological functions regulating immune responses, proliferation / differentiation as well as local blood Perfusion of the skin. The study will test the PSO-CT02 device, an new investigational medical device emitting blue light with a peak wavelength of 453nm on treating localised mild Psoriasis vulgaris. It can be worn on the Skin above the effected skin area. In this study Treatment (target) and control area as well as intensity of blue light are randomized. The control area will serve as reference. 50 Patients will treat the target area daily (at least 5 times/week) at home for an initial treatment period of 4 weeks. During those 4 weeks, patients will return to the study site for safety and effectiveness assessments twice. After this initiation period patients will treat their plaque for further 8 weeks (3 times/week). This is followed by a 4 week follow up phase without treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent prior to any study mandated procedure
- •Good health according to physical examination as determined by the Investigator
- •Willing and able to comply with study requirements
- •Skin type I-IV according to Fitzpatrick
- •Mild plaque-type psoriasis vulgaris with a Psoriasis area severity index (PASI) ≤10 and Body surface area (BSA)
- •≤10 and Dermatology Life quality index (DLQI) ≤ 10 at screening.
- •Presence of two comparable psoriatic plaques suitable to be defined as study areas as follows:
- •located on extremities (plaques located on the palms or sole of the feet are not suitable)
- •Both areas located either on lower or upper extremity
- •Can be located on the same extremity
- •Distance between the two study areas > 10cm (border to border)
- •If lesion is too large to be fully covered, partial treatment possible
- •Aged ≥ 18 years up to <75 years
- •Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year; e.g. oral contraceptives, intra-uterine device [IUD] or transdermal contraceptive patch)
- •Willing to abstain from excessive sun / UV exposure (e.g. sunbathe, solarium) during the course of the study.
排除标准
- •Inmates of psychiatric wards, prisons, or other state institutions
- •Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
- •Participation in another clinical trial within the last 30 days
- •Pregnant or lactating women Medical History
- •Photodermatosis and/or Photosensitivity
- •Porphyria and/or hypersensitivity to porphyrins
- •Patients with current diagnosis of erythrodermic, exfoliative or pustular psoriasis
- •Congenital or acquired immunodeficiency
- •Patients with any of the following conditions present on the study areas: Malignoma of the skin or severe actinic damage of the skin, atypical naevi or signs of hyperpigmentation, viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic Skin
- •Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer (i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom- Syndrome)
结局指标
主要结局
Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity (HI) Group) as Compared to the Control Area at End of Treatment (Visit 7, Week 12).
时间窗: baseline and week 12
In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale: 0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst)).
次要结局
- Difference in Change From Baseline of Local Psoriasis Area Severity Index (PASI) Between Target and Control Area of the High Intensity (HI) Group as Compared to the Low Intensity (LI) Group(baseline and week 4, 8, 16)
- Change From Baseline of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Treatment During the Attack Period (Week 4, Visit 5)(baseline and week 4)
- Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (Low Intensity (LI) Group) as Compared to the Control Area by Week.(baseline and week 4, 12, 16)
- Change From Baseline of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area(baseline and week 4, 12)
- Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)(week 16)
- Change From Week 12 (End of Treatment) of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area at End of Follow-up(week 12 and week 16)
- System Usability Scale(week 12)
- Change From Baseline in Dermatology Life Quality Index (DLQI)(baseline and week 12)
- Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)(patients will be followed for the complete duration of the clinical study for 16 weeks)
- Adverse Device Events (Serious and Non-serious)(week 0, 1, 2, 4, 8, 12, 16)
- Change From Week 12 of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Follow-up(Week 12 and week 16)