Clinical trial NCT04359719: Comparison Between Free Thyroxine and Thyroid Stimulating Hormone Levels on Melasma Severity
Official title: The Comparison Between Free Thyroxine and Thyroid Stimulating Hormone Levels on Melasma Severity: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melasma
Keywords: mMASI
Janus II facial analysis system
TSH
FT4
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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)

Primary outcomes:
measure: association of serum TSH and FT4 level with the severity degree of melasma
timeFrame: 2 weeks: 15 - 26 July 2019
Secondary outcomes:
measure: The correlation of serum TSH and FT4 levels with the Janus facial analysis system
timeFrame: 2 weeks: 15 - 26 July 2019
Other outcomes:
measure: Correlation between Janus II facial analysis system and mMASI score in the mMASI darkness score assesment
timeFrame: 2 weeks: 15 - 26 July 2019
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Irma B Sitohang, MD, PhD
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Irma B Sitohang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: