Comparative Analysis of Small and Large Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- The primary outcome measure is the RT-PCR measurement of IL-17 in lesional psoriasis skin samples collected from patients in Korea.
研究概览
简要总结
Psoriasis is a chronic, debilitating skin disorder with an estimated prevalence of 2%. Psoriatic skin lesions start with initial pinhead-sized macules and then coalesce into plaques of varying sizes. Despite the great strides in the studies for psoriasis, it is still unclear why psoriatic skin lesions start with small macules and then spread peripherally.
To study peripheral spreading of psoriasis, investigators plan to study small plaque psoriasis in comparison to large plaque psoriasis in the Korean population. Large plaque psoriasis is the most common form of psoriasis, seen in approximately 90% of all psoriasis participants. Large psoriatic plaques are >5 cm in size and localize to the extensor aspects of the elbows, knees, scalp, and genital area. On the other hand, small plaque psoriasis is the common or typical form of psoriasis that occurs particularly in Korea and other Asian countries. Korean small plaque psoriasis, even when chronic, remains <2 cm in size and is widely distributed on the upper trunk and proximal extremities.
Investigators hypothesize that the expression of immune-related genes are different between small and large plaque psoriasis. The study of a genetically homogeneous cohort, characterized by the relatively high prevalence of small plaque psoriasis in the Korean population, may filter out spurious signals while allowing for significant associations to emerge from a relatively low number of participants.
By comparing small and large plaque psoriasis, it is expected this study could lead to new understandings of the mechanisms involved in spreading of psoriatic plaques and provide new insights into psoriasis development.
详细描述
Psoriasis is a common chronic skin disorder with an estimated prevalence in populations of approximately 2%. Psoriatic skin lesions start with initial pinhead-sized macules and then coalesce into plaques of varying sizes in diameter from one to several centimeters.
Despite the great strides in the studies for psoriasis, it is still unclear why psoriatic skin lesions start with small macules and then spread peripherally. The occurrence of psoriasis is thought to be the pathological consequence of an exaggerated immune response as activated T cells, monocytes, neutrophils, and dendritic cells produce inflammatory cytokines that drive the additional recruitment of inflammatory cells, further elaboration of proinflammatory mediators, and the proliferation of keratinocytes. However, pathogenetic mechanism for peripheral spreading of psoriasis needs to be further elucidated.
To study peripheral spreading of psoriasis, investigators plan to study "small plaque psoriasis" and compare it to "large plaque psoriasis" in the Korean population.
Psoriasis vulgaris, so-called "large plaque psoriasis", is the most common form of psoriasis, seen in approximately 90% of all psoriasis patients. Red, scaly, symmetrically distributed plaques are usually larger than 5 cm in diameter and characteristically localized to the extensor aspects of the extremities, particularly the elbows and knees, along with scalp, lower lumbosacral, buttocks, and genital involvement. Approximately 1/4 to 1/3 of large plaque psoriasis participants have involvement of over 5% of their body surface area (BSA), and disease of this extent is frequently painful and physically and/or socially debilitating to a degree comparable with other chronic medical conditions.
On the other hand, "small plaque psoriasis" is the common or typical form of psoriasis that occurs in adults particularly in Korea and other Asian countries. Korean small plaque psoriasis, even when chronic, remain <2 cm in size and widely distributed on upper trunk and proximal extremities. Small plaque psoriasis is less severe than large plaque psoriasis, as it usually responds to phototherapy and more potent therapies are rarely needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identified as Korean (defined as being Korean and both parents are Korean)
- •History of small and/or large plaque psoriasis, for at least six months
- •At least 18 years of age
- •No treatment with topical steroids or vitamin D analogues for at least 2 weeks prior to entering the study.
- •No treatment with systemic therapies, including phototherapy, acitretin, cyclosporine, methotrexate and biologics 4 weeks prior to entering the study. Among biologics, Ustekinumab (Stelara®) requires a longer washout period of 12 weeks.
排除标准
- •Erythrodermic, or pustular psoriasis as the sole or predominant form of psoriasis.
- •Photosensitizing illnesses such as lupus, polymorphous light eruption, or any disease known to be worsened by UV light exposure.
- •History of malignant melanoma.
- •Pregnancy.
- •Immunocompromising diseases such as HIV infection.
- •Inflammatory diseases such as but not limited to Crohn's Disease, Multiple Sclerosis, Rheumatoid Arthritis, Hashimoto's Disease.
- •Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data. Participants taking medications that induce photosensitivity may be included after careful review.
- •Poorly controlled medical conditions of any kind.
结局指标
主要结局
The primary outcome measure is the RT-PCR measurement of IL-17 in lesional psoriasis skin samples collected from patients in Korea.
时间窗: 2 years
The primary outcome measure is the expression of IL-17 (the pivotal immune related molecule in psoriasis pathogenesis) in lesional psoriatic skin samples collected from patients in Korea. The expression of IL-17 is measured by Reverse transcription polymerase chain reaction (RT-PCR) and normalized to the expression of housekeeping gene (human acidic ribosomal protein \[hARP\]). The unit of outcome measure is log2(IL-17 expression/hARP expression).
次要结局
- The secondary outcome measure is the RT-PCR measurement of IL-17 in lesional psoriasis skin samples collected from patients at The Rockefeller Hospital, New York.(2 years)
研究者
Jaehwan Kim
Clinical Scholar
Rockefeller University