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

November 24, 2022 updated by: National Taiwan University Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tsen-Fang Tsai, MD
  • Phone Number: 65734 +886-23123456
  • Email: tftsai@yahoo.com

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Yungling Lee, Proseffor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least 20 years of age
  2. Able and willing to provide written informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UVB treatment

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
UVB treatment 3 times per week for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the percentage of Treg cells
Time Frame: 10 weeks
Change from baseline in Treg cell percentage in the peripheral blood of psoriasis patients treated with UVB
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Yungling Lee, Dr, Academia Sinica, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2022

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

November 24, 2022

First Submitted That Met QC Criteria

November 24, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

November 24, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202112019RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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