Comparative Analysis of Small and Large Plaque Psoriasis

NCT01920906 | Completed

• 1 other identifier: JWK-0816
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis

Keywords

Psoriasis; Korean; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the RT-PCR measurement of IL-17 in lesional psoriasis skin samples collected from patients in Korea.

  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).

  2 years

Secondary Outcomes (1)

• 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

Study Arms (1)

Biopsy and blood tests

EXPERIMENTAL

All subjects will undergo a skin biopsy and blood tests

Procedure: Skin biopsy and blood test

Interventions

Skin biopsy and blood test PROCEDURE

Analysis of histology and gene expression in affected and unaffected skin

Biopsy and blood tests

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jaehwan Kim, MD PhD

  Rockefeller Univesrity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scholar

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 12, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 6, 2016

Record last verified: 2016-05

Locations

US (1)