Skip to main content
OpenTrials
Completed

NCT Number: NCT04359719

Comparison Between Free Thyroxine and Thyroid Stimulating Hormone Levels on Melasma Severity

The objective of the study was to compare the level of serum FT4 and TSH in patients with mild melasma and moderate-severe melasma. The determination of melasma lesion could also be known by using Janus II facial analysis UV light and polarization light to analyze the pattern of hyperpigmentation on melasma. This was a descriptive-analytic study used a cross-sectional method that was performed in 2019 at two different dermatology and venerology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta and Gatot Subroto Army Hospital Jakarta. Forty-eight subjects with melasma, 50% diagnosed with mild melasma and 50% with moderate-severe melasma according to the modified melasma area and severity index (mMASI) score. The level of serum FT4 and TSH were then measured in both groups of the patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Irma B Sitohang, MD, PhD

Jakarta Pusat, DKI Jakarta, Indonesia

About this study

Melasma has been suspected to be linked with thyroid hormone. There is no study that explains the association of thyroid hormone level with melasma severity.

This study aims to find the difference in the levels of thyroid hormone in varying severity of melasma.

This was a descriptive-analytic study used a cross-sectional method that was performed in 2019 at two different dermatology and venerology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta and Gatot Subroto Army Hospital Jakarta.

Forty eight patients participated in this study, 50% diagnosed with mild melasma and 50% with moderate-severe melasma. Subjects are chosen consecutively based on mMASI and Janus II measurement. The level of serum FT4 and TSH were then measured in both groups of the patients. The data is tabulated and a comparative analysis of serum FT4 and TSH levels with mild and moderate-severe melasma is done. In addition, this study also analyzes the level of serum FT4 and TSH with the result of Janus II facial analysis system scoring. The same method of analysis was done to know the association between mMASI and examination by using Janus II facial analysis system.

This study aims to find the difference in the levels of thyroid hormone in varying severity of melasma.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20-50 years
  • Melasma lesions on the facial area.
  • Willing to be the subject of research and sign a letter of research approval after being given an explanation (informed consent)

Exclusion criteria

  • Pregnancy
  • History of thyroid disease
  • Using drugs that can affect the thyroid (glucocorticoids, lithium, amiodarone, iodide, octreotide)
  • Using hormonal contraception for the past 1 year
  • Using anti-seizure drugs
  • Using hormone replacement therapy (HRT)
  • Brown spots on the face preceded by reddish spots
  • Brown spots on the face preceded by contact with facial whitening ingredients (hydroquinone)

Treatment and study plan

Primary outcomes

  1. association of serum TSH and FT4 level with the severity degree of melasma

    Time frame: 2 weeks: 15 - 26 July 2019

    There are no association between the level of serum TSH and FT4 and various degrees of melasma

Secondary outcomes

  1. The correlation of serum TSH and FT4 levels with the Janus facial analysis system

    Time frame: 2 weeks: 15 - 26 July 2019

    The correlation is only found between the level of serum FT4 and Janus polarization test

Other outcomes

  1. Correlation between Janus II facial analysis system and mMASI score in the mMASI darkness score assesment

    Time frame: 2 weeks: 15 - 26 July 2019

    A weak positive correlation is found between mMASI score and Janus II facial analysis system with polarization light test. Meanwhile, there is no correlation found between the Janus UV test and mMASI darkness score.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

The Comparison Between Free Thyroxine and Thyroid Stimulating Hormone Levels on Melasma Severity: A Cross Sectional Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2020
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.