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

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT04359719
Collaborator
(none)
48
1
3.4
14.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    48 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Comparison Between Free Thyroxine and Thyroid Stimulating Hormone Levels on Melasma Severity: A Cross Sectional Study
    Actual Study Start Date :
    Jul 15, 2019
    Actual Primary Completion Date :
    Jul 26, 2019
    Actual Study Completion Date :
    Oct 26, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. association of serum TSH and FT4 level with the severity degree of melasma [2 weeks: 15 - 26 July 2019]

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

    Secondary Outcome Measures

    1. The correlation of serum TSH and FT4 levels with the Janus facial analysis system [2 weeks: 15 - 26 July 2019]

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

    Other Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Irma B Sitohang, MD, PhD Jakarta Pusat DKI Jakarta Indonesia

    Sponsors and Collaborators

    • Indonesia University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT04359719
    Other Study ID Numbers:
    • ThyrMel
    First Posted:
    Apr 24, 2020
    Last Update Posted:
    Apr 29, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by 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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 29, 2020