NCT05636839

Brief Summary

The goal of this clinical trial is to compare the immune cell population in blood of the participants with psoriasis/atopic dermatitis before and after UVB treatment. The main questions it aims to answer are:

  1. 1.how immune cells in the PBMCs from blood of participants are affected by UVB treatment
  2. 2.will UVB treatment expand the antigen-specific Treg cell population
  3. 3.will UVB treatment enhance the suppressive function of Treg cells

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 25, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 5, 2022

Status Verified

December 1, 2021

Enrollment Period

3.9 years

First QC Date

November 24, 2022

Last Update Submit

November 24, 2022

Conditions

Keywords

UVB treatmentantigen specificityregulatory T cellmass cytometry

Outcome Measures

Primary Outcomes (1)

  • Change in the percentage of Treg cells

    Change from baseline in Treg cell percentage in the peripheral blood of psoriasis patients treated with UVB

    10 weeks

Study Arms (1)

UVB treatment

EXPERIMENTAL

UVB treatment 3 times per week for 10 weeks Before treatment starts, researchers will collect 20 ml of blood from participants. After 10-week treatment, researchers will collect 20 ml of blood from participants again.

Radiation: UVB treatment

Interventions

UVB treatmentRADIATION

UVB treatment 3 times per week for 10 weeks

UVB treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 20 years of age
  • Able and willing to provide written informed consent

You may not qualify if:

  • UV exposure in the last 8 weeks before study entry
  • Patients with contraindications for UV-treatment
  • History of cancer and primary immunodeficiency
  • pregnant or nursing mother
  • participating in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

PsoriasisDermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Yungling Lee, Dr

    Academia Sinica, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsen-Fang Tsai, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2022

First Posted

December 5, 2022

Study Start

January 25, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 5, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations