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

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359719
• Other study ID #: ThyrMel
• Status: Completed
• Start date: July 15, 2019
• Est. completion date: October 26, 2019

Study information

• Verified date: April 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 26, 2019
• Est. primary completion date: July 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Melanosis
• Melasma

Locations

Country	Name	City	State
Indonesia	Irma B Sitohang, MD, PhD	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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