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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05636839
Collaborator
(none)
20
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1
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Study Details

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:

  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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: UVB treatment
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
UVB-induced Treg Cells Exert Antigen-specific Suppression Through LAG-3
Actual Study Start Date :
Jan 25, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in the percentage of Treg cells [10 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05636839
Other Study ID Numbers:
  • 202112019RINA
First Posted:
Dec 5, 2022
Last Update Posted:
Dec 5, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2022