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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05636839
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Taiwan University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Yungling Lee, Dr
Principal Investigator Affiliation Academia Sinica, Taiwan
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Taiwan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Atopic Dermatitis
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Radiation: - UVB treatment

UVB treatment 3 times per week for 10 weeks

Contact a Trial Team

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International Sites

National Taiwan University Hospital, Taipei, Taiwan

Status

Recruiting

Address

National Taiwan University Hospital

Taipei, , 100

Site Contact

Tsen-Fang Tsai, MD

tftsai@yahoo.com

+886-23123456 #65734

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