Single Center, Randomized, Blinded, Controlled Trial Evaluating the Safety and Effectiveness of Combined 460nm, 633nm and 830nm LED Light for the Treatment of Mild to Moderate Plaque-Type Psoriasis Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Ismart
- 入组人数
- 25
- 主要终点
- Change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of treatment
研究概览
简要总结
The purpose of this study is to investigate whether light therapy can help improve plaque psoriasis. This is a study based on a new medical device. The device produces its light from light emitting diodes. This type of technology has been used for several years in the treatment of other skin conditions. However, the investigators want to study the effect of a combination of very specific wavelengths of light on reducing the signs and symptoms of plaque psoriasis.
The Investigators are looking to recruit 25 volunteers from the general population between the ages of 18 and 65 years old with mild to moderate plaque psoriasis and who are otherwise healthy. The light treatments are 5 times a week for 12 weeks and the treatment is self-administered at home. Each treatment is 15 minutes. The total duration of the study is 16 weeks.
This is a controlled trial. This means that the volunteer will treat one plaque with the light therapy device and the other plaque will remain untreated for the period of the study.
详细描述
This is a single center, randomized, blinded, interindividual, study involving 25 healthy subjects. After informed consent, confidentiality and photographic release forms, volunteers who meet all inclusion criteria and none of the exclusion criteria on page 4, will be entered into the study. Subjects with a PASI of ≤10 will be included in the study.
At Baseline, the Principle Investigator will identify comparable study plaques (where possible the plaques should be of comparable size, duration and severity and where possible on comparable body areas).
The plaques will be evaluated using the Localised Psoriasis Severity Index (LPSI).
At this point and thereafter, the Principle Investigator will be blinded to the intervention/plaque.
The plaques will be numbered 1 and 2 by the study coordinator. The plaques will then be randomised by the study coordinator to receive either the active treatment or act as the control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Randomization will be conducted by the study coordinator and will take place in a separate room away from the PI.
The Study coordinator will number the 2 plaques 1 and 2. The Study coordinator will draw a sequential envelope containing the randomization code for the control and test. The code will inform the study coordinator which plaque is control and which test.
The Study coordinator will complete the randomization coding worksheet which identifies the test and control plaque and location.
The randomization coding worksheet will be kept separate from the subjects' case report form.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male & females; 18 to 65 years of age with mild to moderate psoriasis ≤10 PASI according to the Psoriasis Area Severity Index.
- •Plaques comparable in terms of size, duration and severity and where possible on comparable body areas according to the localized psoriasis severity index (LPSI).
- •Fitzpatrick, I-V photo type skin types. Written informed consent is given. Volunteers agree NOT to use any over the counter or prescriptive psoriasis treatments during the study period unless specifically advised by the research staff.
排除标准
- •Volunteers who suffer from Erythrodermic, exfoliative or pustular psoriasis. Volunteers who suffer from a systemic photosensitive disorder such as Lupus erythematosus, photosensitive eczema or Albinism.
- •Volunteers who suffer from genetic deficiencies that increase susceptibility to dermatologic cancer such as Xeroderma pigmentosum.
- •Volunteers who suffer from diffuse actinic damage of the skin. Volunteers who suffer from localised fungal or bacterial skin infections in or around the treatment area.
- •Volunteers currently taking (or a history of taking) medication listed in Photosensitive drug list in instructions for use.
- •Subjects who have any known allergies to the ingredients in the emollient used in the study.
- •Volunteers with known malignancy and or undergoing chemotherapy, radiotherapy or high doses of corticosteroids.
- •Volunteer suffers from keloid scars, or birthmarks in the treatment area. Females who are pregnant, breastfeeding or who wish to become pregnant during the study period.
- •Enrolled in another clinical trial during the same study period. The volunteer has a planned hospital admission and/or surgical procedure for an illness or disease which existed before enrolment into the clinical trial and which may interfere with the course or outcome of the study.
- •The volunteer has a medical or psychological condition(s) associated with a risk of poor protocol compliance (e.g. alcoholism or drug abuse).
- •A volunteer is undergoing or is likely to undergo other treatments.
结局指标
主要结局
Change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of treatment
时间窗: 84 days from baseline
A change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of treatment period (84 days)
次要结局
- Change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of study period(112 days from baseline)