Controlled Crossover Study to Evaluate the Efficacy of the handLITE LED Device in Treating the Signs of Contact/Irritant Dermatitis of the Hand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Steven Baker
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Reduction in the signs and symptoms of contact/irritant dermatitis of the hand according to a Modified SCORAD system
研究概览
简要总结
This study is intended to be a cross over study. Subjects will treat one hand while the contralateral hand acts as a control. At the end of 6 weeks the subject will be instructed to cease treatment of the test hand and commence treatment of the control hand for 6 weeks. Efficacy will be evaluated at 6 weeks after the beginning of the treatment and 12 weeks (end of crossover).
详细描述
This is a single-center study intended to be a cross-over study. Subjects will treat one hand while the contralateral hand acts as a control. At the end of 6 weeks, the subject will be instructed to cease treatment of the test hand and commence treatment of the control hand for 6 weeks. Efficacy will be evaluated at 6 weeks after the beginning of the treatment and 12 weeks (end of crossover). There will be no wash-out period during the crossover as this is not a systemic drug that has a half-life, and we expect subjects to still be exposed to the contact irritants. A crossover trial was chosen since this makes more use of a smaller trial group and removes the need for a separate parallel control group, therefore reducing trial numbers and allowing all subjects to be given the active treatment.
Since contact dermatitis is a chronic condition affected by external factors the skin condition should persist long enough for the investigator to expose the subject to the experimental treatment and measure the response. Since the subjects will still be exposed to their contact irritants as part of their daily life there should be no reason to introduce a washout period and since each subject acts as their own control, any systemic spread should be compensated for.
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
PI will not know which is the treatment or control hand.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between the ages of 21 and 75 years
- •Subject with mild to moderate no greater than 50 on the SCORAD Index or 40 on the Objective SCORAD index stable contralateral contact/irritant dermatitis of the hand.
- •Subjects agree to treat only one hand at a time for 6 weeks, the other acting as a control.
- •4-week washout period has elapsed since subject received topical treatments for contact/irritant dermatitis and oral antibiotics.
- •Subjects agree to use a non-mediated soap substitute supplied for their use during the study period (Syndet)
- •Subjects agree to NOT use any emollients 24 hours prior to their assessment days.
排除标准
- •Subjects <21 and >75years of age.
- •Subject with a grading score of > than 50 on the SCORAD Index or >40 on the Objective SCORAD index)
- •The subject has lichenized or urticated papules or plaques.
- •Subject has exudative atopic dermatitis
- •Subject has localized infection
- •Subjects currently taking prescriptive corticosteroids and antibiotics (topical or systemic).
- •Subjects who have received PUVA or UVB therapy or any immunosuppressive therapy I the last 8 weeks.
- •Planned exposure to sun, UVA or UVB that may affect the treatment area during the study period.
- •Subjects who suffer from systemic photosensitive disorder such as Lupus erythematosus, photosensitive eczema, or Albinism.
- •Subjects currently taking (or a history of taking) medication known to induce photosensitivity.
- •Subjects who are pregnant or planning pregnancy during the study, breastfeeding mothers.
- •Subjects enrolled in another clinical trial during the same study period.
- •Subjects who have participated in a clinical trial in the last 30 days.
- •Subjects who have 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.
- •Subjects who have a planned vacation that would exclude them from attending follow up evaluations.
- •Subject has medical or psychological condition(s) associated with a risk of poor protocol compliance (e.g., alcoholism or drug abuse).
- •Subject is undergoing or is likely to undergo other treatments.
结局指标
主要结局
Reduction in the signs and symptoms of contact/irritant dermatitis of the hand according to a Modified SCORAD system
时间窗: at 6-weeks
eduction in the signs and symptoms of contact/irritant dermatitis of the hand according to a Modified SCORAD system
次要结局
- Subjective assessment of treatment response (POEM)(At 6 weeks)