Inflammation in Melasma: Study of Its Infiltrate and the Expression of Acute and Chronic Mediators

November 22, 2014 updated by: Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí

Melasma is an acquired hyperpigmentary disorder that commonly affects women from Asia and Latin-America.There is evidence of subclinical inflammation supported by diffuse spectrometry and by prominent inflammatory cells in affected areas; however this infiltrate and its inflammatory mediators remains unexplored. Chronic inflammation induces melanogenesis and angiogenesis; thus, it could be linked to its recurrent nature.Therefore, the aim of this study is to describe the inflammatory cellular infiltrate, and the expression of main inflammatory and angiogenic mediators in this condition, as well as to explore its relationship with severity of disease.

Using histological, histochemistry, immunohistochemistry, and quantitative real-time PCR, we evaluated melasma lesions from 20 healthy female patients with malar melasma without specific solar exposure or photoprotection measures within the previous 3 weeks and compared them to non lesional skin.

Study Overview

Status

Completed

Conditions

Detailed Description

Melasma is a frequent, photoinduced, pigmentary disorder among latin-american women. Its etiology is not completely elucidated; however, there is evidence of a melanogenic paracrine cytokine network between the melanocyte and other skin cells, including keratinocytes, fibroblasts, vascular and inflammatory cells, which regulate melanocyte function.

Previous reports in lesional skin have described increased mast cell infiltration in elastotic areas, presence of a moderate lymphohistiocytic infiltrate, increased vascularity, and up-regulation of proangiogenic factors. This histological evidence of skin inflammation is also supported clinically by colorimetry and thermography, and by the improvement of pigmentation with topical anti-inflammatories.

Photoinduced dermal inflammation might be related to epidermal hyperpigmentation through the production of melanogenic cytokines, and growth factors, and through the secretion of COX-2 induced prostaglandins by keratinocytes, a mechanism involved in the pathogenesis of postinflammatory hyperpigmentation which has not been evaluated in melasma.

The aim of this study is to describe the ongoing characteristics of inflammation in this condition by measuring the cellular infiltrate, the expression of acute and chronic immune inflammatory mediators, and non-immune inflammation mechanism such as COX-2, as well as to explore its relationship with severity of disease, elastosis, and melanin staining.

Twenty healthy female patients with malar melasma without specific solar exposure or photoprotection measures within the previous 3 weeks were enrolled. Disease severity was estimated using the Melasma Area and Severity Index (MASI). Histological, histochemical, immunohistochemistry, and quantitative real-time PCR were used to evaluate the presence of these markers in melasma lesions and compare them to nonlesional skin.

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 Potosi, Mexico, 78210
        • 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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women affected with malar melasma.

Description

Inclusion Criteria:

  • Women older than 18 years under signed informed consent form.
  • Symmetrical and bilateral lesions.
  • Melasma with MASI scores greater than 12 points.

Exclusion Criteria:

  • Melasma treatment or photoprotection measures within last 2 months.
  • Pregnant women or nursing.
  • Miscarriage or labor in the last 12 months.
  • Menopause
  • Coexistence of other pigmentation disorders.
  • Infrared radiation exposure.
  • Regular exercise or diet restriction.
  • Consumption of food supplements.
  • Any type of drugs consumption in the last 2 months (i.e anti-inflammatories and hormonal treatments)
  • Personal history of keloid or hypertrophic scars.
  • Lidocaine allergy.

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-Crossover
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Melasma
Women affected by symmetric facial malar melasma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory cellular infiltrate
Time Frame: Single time measurement
Determine by immunohistochemistry common inflammatory cellular infiltrate in melasma lesions and non affected skin (i.e CD1, CD68, CD4, CD8).
Single time measurement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute inflammatory mediators
Time Frame: Single time measurement
Determine by immunohistochemistry, and PCR techniques, the expression of IL1 alpha, IL1 beta, IL1 alpha receptor, and VEGF in melasma lesions and non affected skin.
Single time measurement
Chronic inflammatory mediators
Time Frame: Single time measurement
Determine by immunohistochemistry, and PCR techniques, the expression of COX-2, and IL-17 in melasma lesions and non affected skin.
Single time measurement

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between inflammation markers and pigmentation
Time Frame: Single time measurement
Analyze inflammation parameters and to correlate data with melanin, elastosis, and clinical parameters of severity.
Single time measurement

Collaborators and Investigators

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

Sponsor

Universidad Autonoma de San Luis Potosí

Collaborators

Hospital Central "Dr. Ignacio Morones Prieto"

Investigators

  • Study Chair: Bertha Torres-Alvarez, MD, Hospital Central "Dr. Ignacio Morones Prieto"
  • Principal Investigator: Adriana Rodriguez-Arambula, MD, Hospital Central "Dr. Ignacio Morones Prieto"

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

July 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 27, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 22, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mel-Infla1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Melasma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe