Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant)
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
研究概览
简要总结
The purpose of this prospective study is to evaluate the degree of post-inflammatory pigmentation alteration on legs of study subjects treated with two different psoriasis treatments. Betamethasone dipropionate 0.05% cream is a high potency steroid that is commonly used to alleviate the inflammation of psoriasis. Tapinarof is another medication approved for psoriasis; tapinarof activates aryl hydrocarbon receptors to downregulate inflammatory cytokines (such as interleukin [IL]-17) which play a large role in psoriasis. Study subjects will be randomized to receive one of these medications and will be followed to monitor for PIPA. Photographs will be taken to help evaluate visual changes. The Taylor Hyperpigmentation scale will be used to grade the area and severity of hyperpigmentation and hypopigmentation; severity of erythema, burning, peeling, and dryness will also be recorded. This will allow us to understand the effects of two standard-of-care psoriasis medications to better treat patients.
详细描述
Subjects will be randomized to either of the two treatment groups (betamethasone dipropionate or tapinarof) and will be treated with that medication for until clear or up to 12 weeks . Photographs will be taken before and after treatment. The betamethasone dipropionate 0.05% cream group will be treated with betamethasone dipropionate 0.05% cream once daily on both legs until clear or up to 12 weeks. The tapinarof group will be treated with 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks.
Subjects will return every 4 weeks for evaluation. If disease recurs after clearing, treatment will be re-instituted.
Both groups will also be followed up at 1 and 4 weeks after end of treatment to monitor for PIPA and any other after-treatment effects.
Healthcare providers and patients may benefit from the information obtained during this study; study subjects may directly benefit from participation as they will be treated with standard treatments for psoriasis. We hope the information gathered will help healthcare providers better serve patients and identify psoriasis treatment after-effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Adults (age 18+) with Fitzpatrick skin type 3 or higher who have been diagnosed with ICD10 code L40.9 for psoriasis between [dates] at Atrium Health Wake Forest Baptist Medical Center.
- •Stable on other therapies such as biologics for at least 3 months before randomization.
排除标准
- •Lack of a diagnosis of psoriasis (ICD10 code L40.9) or Fitzpatrick skin type below
- •Pigmentary changes that in the opinion of the investigator would compromise the ability to assess the study outcomes.
研究组 & 干预措施
Betamethasone dipropionate 0.05%
The betamethasone dipropionate 0.05% cream group will be treated with betamethasone dipropionate 0.05% cream once daily on both legs until clear or up to 12 weeks.
干预措施: Betamethasone dipropionate 0.05% (Drug)
Tapinarof
The tapinarof group will be treated with 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks.
干预措施: Tapinarof (Drug)
结局指标
主要结局
Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
时间窗: Week 4 to week 12
Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale
Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
时间窗: Baseline to week 1
Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale
Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
时间窗: Week 1 to week 4
Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale
次要结局
未报告次要终点