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

NCT ID: NCT05636839

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-25

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis Atopic Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

UVB treatment

Intervention Type RADIATION

UVB treatment 3 times per week for 10 weeks

Interventions

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UVB treatment

UVB treatment 3 times per week for 10 weeks

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yungling Lee, Dr

Role: PRINCIPAL_INVESTIGATOR

Academia Sinica, Taiwan

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tsen-Fang Tsai, MD

Role: CONTACT

+886-23123456 ext. 65734

Facility Contacts

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Tsen-Fang Tsai, MD

Role: primary

+886-23123456 ext. 65734

Other Identifiers

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202112019RINA

Identifier Type: -

Identifier Source: org_study_id

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