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UVB-induced Treg Cells Exert Antigen-specific Suppression Through LAG-3

Primary Purpose

Psoriasis, Atopic Dermatitis

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
UVB treatment
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psoriasis focused on measuring UVB treatment, antigen specificity, regulatory T cell, mass cytometry

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least 20 years of age Able and willing to provide written informed consent Exclusion Criteria: 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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UVB treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 24, 2022
Last Updated
November 24, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05636839
Brief Title
UVB-induced Treg Cells Exert Antigen-specific Suppression Through LAG-3
Official Title
UVB-induced Treg Cells Exert Antigen-specific Suppression Through LAG-3
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: how immune cells in the PBMCs from blood of participants are affected by UVB treatment will UVB treatment expand the antigen-specific Treg cell population will UVB treatment enhance the suppressive function of Treg cells Participants giving written informed consent will donate their blood (20 ml) before UVB treatment begins. After 8 to 10-week treatment course, the participants will donate their blood (20 ml) again. Researchers will compare immune cell population changes in the PBMCs of participants before and after UVB treatment. In addition, researchers will purify Treg cells from participant blood before and after UVB treatment to test their suppressive activity by ex vivo suppression assay.
Detailed Description
UVB irradiation suppresses immune responses partly via the induction of Treg cells. However, it is still not clear whether the therapeutic effect of UVB to treat skin inflammatory diseases (such as psoriasis and atopic dermatitis) results from the increase of Treg cell population. In addition, how UVB induces antigen-specific Treg cells needs to be elucidated. In this study, researchers will examine the Treg cell population in the blood of participants with psoriasis or atopic dermatitis under UVB treatment. We will analyse changes of immune cell populations in the blood of participants using mess cytometry. We will also investigate the suppressive function of Treg cells sorted from peripheral blood mononuclear cells (PBMCs) to see whether UVB treatment will affect the function of Treg cells. Enrolled participants will donate 20 ml of blood before UVB treatment begins. They will receive UVB irradiation 2 to 3 times per week, and the treatment course will last 8 to 10 weeks, which is defined as a complete treatment. After a complete treatment, the participants will donate 20 ml of blood again, and the trial ends.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Atopic Dermatitis
Keywords
UVB treatment, antigen specificity, regulatory T cell, mass cytometry

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UVB treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
UVB treatment
Intervention Description
UVB treatment 3 times per week for 10 weeks
Primary Outcome Measure Information:
Title
Change in the percentage of Treg cells
Description
Change from baseline in Treg cell percentage in the peripheral blood of psoriasis patients treated with UVB
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 20 years of age Able and willing to provide written informed consent Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tsen-Fang Tsai, MD
Phone
+886-23123456
Ext
65734
Email
tftsai@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yungling Lee, Dr
Organizational Affiliation
Academia Sinica, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsen-Fang Tsai, MD
Phone
+886-23123456
Ext
65734
Email
tftsai@yahoo.com
First Name & Middle Initial & Last Name & Degree
Yungling Lee, Proseffor

12. IPD Sharing Statement

Plan to Share IPD
No

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UVB-induced Treg Cells Exert Antigen-specific Suppression Through LAG-3

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