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临床试验/NCT04359719
NCT04359719已完成不适用

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

Indonesia University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
association of serum TSH and FT4 level with the severity degree of melasma

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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)

结局指标

主要结局

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

时间窗: 2 weeks: 15 - 26 July 2019

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

次要结局

  • The correlation of serum TSH and FT4 levels with the Janus facial analysis system(2 weeks: 15 - 26 July 2019)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.dr.Irma Bernadette, SpKK (K)

Irma Bernadette S. Sitohang, MD, PhD-Head of Division of Cosmetic Dermatology, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Indonesia University

研究点 (1)

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