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

NCT ID: NCT04359719

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2019-10-26

Brief 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.

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.

Conditions

Melasma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irma B Sitohang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Locations

Irma B Sitohang, MD, PhD

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

ThyrMel

Identifier Type: -

Identifier Source: org_study_id