An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Efficacy as Measured by the Mean Percentage Change in the Product of Static Physician Global Assessment (sPGA) and Body Surface Area (BSA).
研究概览
简要总结
Psoriasis vulgaris is a common inflammatory condition of the skin that results in well-demarcated, scaly, erythematous, itchy plaques. In the United States, psoriasis remains a common, immune-mediated disease, affecting 7.4 million adults. Often topical prescription medications are used as first line treatment for moderate psoriasis. Some topical medications have side effects and risk with long time use, thus not ideal for extensive and indefinite amount of time. Conversely, over- the-counter emollient treatments are readily available, safe and potentially efficacious. This study is design to test the safety and efficacy of topical application of the Metaderm product cream. The Metaderm cream is non-prescription, natural product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nonsystemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1)
Patients who received HAT1 and were not on systemic treatment at time of enrollment. Metaderm cream will be applied topically twice a day to all active lesions. The metaderm scalp spray will be applied daily to the affected areas on the scalp.
干预措施: Metaderm (Drug)
Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1)
Patients who received HAT1 and were on systemic treatment at time of enrollment. Metaderm cream will be applied topically twice a day to all active lesions. The metaderm scalp spray will be applied daily to the affected areas on the scalp.
干预措施: Metaderm (Drug)
结局指标
主要结局
Efficacy as Measured by the Mean Percentage Change in the Product of Static Physician Global Assessment (sPGA) and Body Surface Area (BSA).
时间窗: Baseline to Week 12
The sPGA is the physician's global assessment of the subjects plaque psoriasis at a given time point. Plaques are assessed for induration, erythema, and scaling and an overall rating of plaque psoriasis severity is gen using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). The BSA is the amount of body surface area affected by a disease. In this, the head represents 10% of the body, the upper extremities 20%, the trunk 30%, and the lower extremities 40%. These assessments will be combined by multiplying the numerical outcomes of the sPGA and BSA assessments to form a result. The mean change in this result will then be reported as the efficacy outcome. The data was all inclusive and not divided out by arm.
次要结局
- Efficacy as Measured by the Percentage Change in the DLQI. (Dermatology Quality of Life Index).(Baseline to Week 12)
研究者
Boni Elewski
Profesor and Chair, Department of Dermatology
University of Alabama at Birmingham