Tissue-resident Memory T Cells Expression in Melasma

January 15, 2023 updated by: Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí
The treatment of melasma and the maintenance of depigmentation represent a challenge due to its frequent recurrences. Pathophysiological mechanisms and factors have been linked to melasma such as inflammation, sun exposure, increased CD4+ T lymphocytic infiltrate and IL-17 in damaged skin. Tissue-resident memory T cells (Trm), derived from naïve T lymphocytes, are associated with the recurrence of lesions at the same sites but they have not been described in melasma. This a Cross-sectional, prospective analytical study. 20 female patients, 18 to 55 years of age, with diagnosis of melasma and mMASI score of at least 7, at least 1-year duration, lesional and perilesional skin biopsies were taken for PCR and DIF. The objective is to determine the transcription factors of Trm cells in malar melasma.

Study Overview

Status

Completed

Conditions

Detailed Description

Melasma is a common, acquired pigmentary disorder characterized by chronic and relapsing hypermelanosis on sun-exposed areas that causes significant emotional and psychosocial impact in patients mainly in women with Fitzpatrick III-V phototypes. The treatment of melasma and the maintenance of depigmentation represents a challenge due to its frequent recurrences.

Different pathophysiological mechanisms and factors have been linked to melasma such as inflammation, sun exposure, increased CD4+ T lymphocytic infiltrate and IL-17 in damaged skin. In pathologies such as vitiligo and psoriasis, tissue-resident memory T cells (Trm), derived from naïve T lymphocytes, are associated with the recurrence of lesions at the same sites. These cells have a specific profile of transcription factors (Runx3+, Notch+, Blimp1+) and CD69 + CD103 + markers. These cells have not been described in melasma.

Objective: to determine the transcription factors of Trm cells in malar melasma. This is a Cross-sectional, prospective analytical study. 20 female patients, 18 to 55 years of age, with diagnosis of melasma and mMASI score of at least 7, at least1 year duration, and no treatment in the last 4 weeks, were included. Lesional and perilesional skin biopsies were taken for PCR and DIF. The presence of trm cells has not been described or studied in melasma where there is recurrence of the dermatosis in the same site, it is essential to understand its pathogenesis in order to address directed future therapies targeting these cells that may related to the disease.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

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

Study Locations

  • Mexico
      • San Luis Potosí, Mexico, 78290
        • Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

female patients with malar melasma, healthy volunteers 18 years of age and older, without previous treatment or photoprotection measures within the previous 4 weeks, who had at least 7 Modified Melasma Activity and Severity Index (mMASI) score

Description

Inclusion Criteria:

female patients with malar melasma, healthy volunteers 18 years of age and older, without previous treatment or photoprotection measures within the previous 4 weeks, who had at least 7 Modified Melasma Activity and Severity Index (mMASI) score

Exclusion Criteria:

  • Exclusion criteria were pregnancy or nursing, menopause, coexistence of other pigmentation conditions, heat exposure, regular exer- cise, diet restriction, consumption of food supplements or any type of drugs (including anti-inflammatories and hormonal treatments) within the previous 2 months, and women who had given birth within 1 year

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Melasma mMASI 7
Female patients with melasma mMASI at least 7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue-resident memory T cells
Time Frame: up to 1 year
To determine the difference in the levels of transcription factors of TRM cells in lesional skin and perilesional skin of patients with melasma
up to 1 year

Collaborators and Investigators

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

Sponsor

Universidad Autonoma de San Luis Potosí

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2021

Primary Completion (Actual)

July 30, 2022

Study Completion (Actual)

December 20, 2022

Study Registration Dates

First Submitted

January 15, 2023

First Submitted That Met QC Criteria

January 15, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 15, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81-21

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

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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