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

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

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.

Study Overview

• Status: Completed
• Conditions: Melasma

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia
      • Irma B Sitohang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The target population is patients with melasma in Indonesia aged 20-50 years.

Affordable population are patients with melasma who come to the Skin and Genital Clinic of RSCM aged 20-50 years in the study period.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group mild melasma; This subjects according to the modified melasma area and severity index (mMASI) score. Variables that are measure by mMASI scoring includes the degree of darkness and involvement of area. Darkness component is used to replace pigmentation and intensity in MASI scoring with modification (mMASI). Assessment using mMASI is highly dependent on the operator; hence, a new objective examination to assess skin pigmentation have been developed, which is the facial imaging analysis. The level of serum FT4 and TSH were then measured in both groups of the patients. In addition, the degree of skin pigmentation was also measured by using the Janus II facial analysis system. In this study, there were two modalities used in the Janus II facial analysis system, which is the polarization light and ultraviolet light. In addition, this study also analyzes the level of serum FT4 and TSH with the result of Janus II facial analysis system scoring.
Group Moderate-severe melasma; This subjects according to the modified melasma area and severity index (mMASI) score. Variables that are measure by mMASI scoring includes the degree of darkness and involvement of area. Darkness component is used to replace pigmentation and intensity in MASI scoring with modification (mMASI). Assessment using mMASI is highly dependent on the operator; hence, a new objective examination to assess skin pigmentation have been developed, which is the facial imaging analysis. The level of serum FT4 and TSH were then measured in both groups of the patients. In addition, the degree of skin pigmentation was also measured by using the Janus II facial analysis system. In this study, there were two modalities used in the Janus II facial analysis system, which is the polarization light and ultraviolet light. In addition, this study also analyzes the level of serum FT4 and TSH with the result of Janus II facial analysis system scoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
association of serum TSH and FT4 level with the severity degree of melasma	There are no association between the level of serum TSH and FT4 and various degrees of melasma	2 weeks: 15 - 26 July 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation of serum TSH and FT4 levels with the Janus facial analysis system	The correlation is only found between the level of serum FT4 and Janus polarization test	2 weeks: 15 - 26 July 2019

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between Janus II facial analysis system and mMASI score in the mMASI darkness score assesment	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.	2 weeks: 15 - 26 July 2019

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Irma B Sitohang, MD, PhD, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): July 26, 2019
• Study Completion (Actual): October 26, 2019

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: TSH; mMASI; Janus II facial analysis system; FT4
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis
• Other Study ID Numbers: ThyrMel

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