NCT05506995

Brief Summary

Vitiligo is the most commonly acquired depigmentation disorder characterized by selective destruction of melanocytes resulting in well-circumscribed achromic macules. Tissue-resident memory T cells (TRM) are memory T lymphocyte subsets that reside in the skin, lack recirculation, proliferate locally, produce cytokines, and may be implicated in relapses. NB-UVB Phototherapy induces repigmentation in certain patterns. The aim of this study was to determine the levels of TRM cells on vitiligo lesions, and after phototherapy by repigmentation pattern.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

August 16, 2022

Last Update Submit

August 16, 2022

Conditions

Keywords

vitiligoUltraviolet TherapyPigmentationTissue-resident memory T cellsHobbitBlimp1Runx3Notch1

Outcome Measures

Primary Outcomes (1)

  • Tissue-resident memory T cells

    To quantify the expression of Tissue-resident memory T cells before and after phototherapy

    Up to 1 year

Secondary Outcomes (3)

  • Tissue-resident memory T cells among the repigmentation patterns

    Up to 1 year

  • Arrangment of the Tissue-resident memory T cells among the repigmentation patterns

    Up to 1 year

  • TRM transcriptional factors profile

    Up to 1 year

Study Arms (1)

Vitiligo vulgaris

A serial of vitiligo patients under treatment with UVB-NB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with clinical diagnosis of vitiligo vulgaris with more than 10 percent of the total body surface affected.

You may qualify if:

  • years of age or older
  • Symmetric vitiligo
  • Affected body surface greater than 10%
  • Patients with follicular, marginal and diffuse repigmenting patterns
  • No previous topical or systemic treatment in the previous 2 and 3 months, respectively
  • Signed informed consent

You may not qualify if:

  • Concomitant treatment or systemic diseases
  • Pregnancy
  • Drugs intake
  • Mental disorders
  • Acral, universal or segmental vitiligo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, 78290, Mexico

Location

Related Publications (10)

  • Bae JM, Jung HM, Hong BY, Lee JH, Choi WJ, Lee JH, Kim GM. Phototherapy for Vitiligo: A Systematic Review and Meta-analysis. JAMA Dermatol. 2017 Jul 1;153(7):666-674. doi: 10.1001/jamadermatol.2017.0002.

  • Fraczek A, Owczarczyk-Saczonek A, Placek W. The Role of TRM Cells in the Pathogenesis of Vitiligo-A Review of the Current State-Of-The-Art. Int J Mol Sci. 2020 May 18;21(10):3552. doi: 10.3390/ijms21103552.

  • Riding RL, Harris JE. The Role of Memory CD8+ T Cells in Vitiligo. J Immunol. 2019 Jul 1;203(1):11-19. doi: 10.4049/jimmunol.1900027.

  • Richmond JM, Strassner JP, Rashighi M, Agarwal P, Garg M, Essien KI, Pell LS, Harris JE. Resident Memory and Recirculating Memory T Cells Cooperate to Maintain Disease in a Mouse Model of Vitiligo. J Invest Dermatol. 2019 Apr;139(4):769-778. doi: 10.1016/j.jid.2018.10.032. Epub 2018 Nov 10.

  • Behr FM, Chuwonpad A, Stark R, van Gisbergen KPJM. Armed and Ready: Transcriptional Regulation of Tissue-Resident Memory CD8 T Cells. Front Immunol. 2018 Jul 30;9:1770. doi: 10.3389/fimmu.2018.01770. eCollection 2018.

  • Mackay LK, Minnich M, Kragten NA, Liao Y, Nota B, Seillet C, Zaid A, Man K, Preston S, Freestone D, Braun A, Wynne-Jones E, Behr FM, Stark R, Pellicci DG, Godfrey DI, Belz GT, Pellegrini M, Gebhardt T, Busslinger M, Shi W, Carbone FR, van Lier RA, Kallies A, van Gisbergen KP. Hobit and Blimp1 instruct a universal transcriptional program of tissue residency in lymphocytes. Science. 2016 Apr 22;352(6284):459-63. doi: 10.1126/science.aad2035.

  • Zubair R, Hamzavi IH. Phototherapy for Vitiligo. Dermatol Clin. 2020 Jan;38(1):55-62. doi: 10.1016/j.det.2019.08.005. Epub 2019 Oct 18.

  • Castanedo-Cazares JP, Cortes-Garcia JD, Fuentes-Ahumada C, Martinez-Rosales K, Torres-Alvarez B. Repigmentation patterns induced by NB-UVB and their relationship with melanocytic migration and proliferation in vitiligo. Photodermatol Photoimmunol Photomed. 2016 Sep;32(5-6):269-275. doi: 10.1111/phpp.12275. Epub 2016 Oct 5.

  • Patra V, Laoubi L, Nicolas JF, Vocanson M, Wolf P. A Perspective on the Interplay of Ultraviolet-Radiation, Skin Microbiome and Skin Resident Memory TCRalphabeta+ Cells. Front Med (Lausanne). 2018 May 30;5:166. doi: 10.3389/fmed.2018.00166. eCollection 2018.

  • Azzolino V, Zapata L Jr, Garg M, Gjoni M, Riding RL, Strassner JP, Richmond JM, Harris JE. Jak Inhibitors Reverse Vitiligo in Mice but Do Not Deplete Skin Resident Memory T Cells. J Invest Dermatol. 2021 Jan;141(1):182-184.e1. doi: 10.1016/j.jid.2020.04.027. Epub 2020 May 25. No abstract available.

Biospecimen

Retention: SAMPLES WITH DNA

Skin biopsies

MeSH Terms

Conditions

VitiligoBicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAortic Valve DiseaseHeart Valve DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Juan P Castanedo-Cazares, MD

    Universidad Autonoma de San Luis Potosi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical and research professor in Dermatology

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

August 1, 2021

Primary Completion

July 24, 2022

Study Completion

August 3, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations