NCT03526705

Brief Summary

Psoriasis is an immune-mediated skin disease that affects 1-2 % of the population. Several cytokines have been found to be involved in the complex pathogenesis of this disease. Il- 36 is one of the cytokines sharing in psoriasis pathogenesis, as its levels are elevated in psoriatic plaques. Cathepsin G is known to activate Il- 36 and promote inflammation in psoriasis.NB-UVB is one of the important treatment modalities for psoriasis. The aim of this study is to detect the effect of NB-UVB on the lesional levels of IL-36 in psoriasis.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

May 4, 2018

Last Update Submit

July 20, 2019

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • changes in Il-36 levels in 25 psoriasis patients after 26 sessions of NB-UVB

    primary

    6 months

Secondary Outcomes (1)

  • changes in cathepsin G levels in 25 psoriasis patients after 26 sessions of NB-UVB psoriasis

    6 months

Study Arms (1)

nb-uvb

EXPERIMENTAL

psoriasis patients will receive 26 sessions of nb-uvb phototherapy

Device: NB-UVB

Interventions

NB-UVBDEVICE

Phototherapy

nb-uvb

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with psoriasis vulgaris of both sexes
  • Age between 18 and 60 years old.

You may not qualify if:

  • Pregnant females
  • Patients receiving systemic treatment or topical treatment for psoriasis within the past two months.
  • Patients having other dermatological diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 16, 2018

Study Start

July 15, 2019

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

July 23, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share