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

NCT04359719 | Completed

• 1 other identifier: ThyrMel
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Keywords

mMASI; Janus II facial analysis system; TSH; FT4

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The correlation of serum TSH and FT4 levels with the Janus facial analysis system

  2 weeks: 15 - 26 July 2019

Other Outcomes (1)

• Correlation between Janus II facial analysis system and mMASI score in the mMASI darkness score assesment

  2 weeks: 15 - 26 July 2019

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Irma B Sitohang, MD, PhD

Jakarta Pusat, DKI Jakarta, Indonesia

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Irma B Sitohang, MD, PhD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: July 15, 2019
• Primary Completion: July 26, 2019
• Study Completion: October 26, 2019
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)