Comparative Study of mMASI Before and After Hyperthyroid Therapy in Hyperthyroid Subjects With Melasma

Study Overview
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Brief Summary
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Study's objectives are to determine proportion of melasma cases in hyperthyroid patients and to compare severity of melasma before and after medications of three months hyperthyroid therapy using modified melasma area and severity index (mMASI) score. A quasi experimental (pre-post intervention) study was conducted in Jakarta in August 2019-February 2020.

Detailed Description
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Melasma is an acquired and chronic disorder of hyperpigmentation characterized by symmetrical hypermelanoses of the face. The exact pathogenesis of melasma is still unknown. Several hormones are thought to play a role, including thyroid hormone. Although melasma is not life-threatening, it affects greatly on the quality of life of patients. Study's objectives are to determine proportion of melasma cases in hyperthyroid patients and to compare severity of melasma before and after medications of three months hyperthyroid therapy using mMASI score. An experimental (before and after) study was conducted in Jakarta in August 2019-February 2020. Twenty three newly-diagnosed hyperthyroid patients or had taken hyperthyroid medications of maximum 3 months with melasma were recruited. The severity of melasma were scored with mMASI and dermoscopy of the lesions were collected. The same procedures were done after 3 months of hyperthyroid therapy. The data collected was statistically analyzed using Stata version 15.0

Official Title
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Comparative Study of mMASI Before and After Hyperthyroid Therapy in Hyperthyroid Subjects With Melasma

Conditions
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Melasma, Hyperthyroidism

Intervention / Treatment
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* Drug: Thiamazol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female with age range of 18 to 60 years old Newly diagnosed with hyperthyroid on a laboratory basis Diagnosed with melasma by dermatologist Exclusion Criteria: Pregnant or breastfeeding Using hormonal contraception or history of using hormonal contraception within 1 year On anti-seizure therapy or hormone replacement therapy History of drug use that can affect the thyroid History of using topical hydroquinone in the last 3 months and / or using a topical steroid and / or an vitamin A analog and / or received chemical peeling in the last 1 month History of laser therapy and / or mechanical abrasion therapy in the past 9 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Intervention<br>Before-and-After type of research | Drug: Thiamazol<br>* All new hyperthyroid with melasma patients were recruited and their mMASI were calculated All subjects were given thiamazole by Internist based on their clinical hyperthyroidism After 3 months of taking hyperthyroid drugs (thiamazole), mMASI were recalculated and compared<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mMASI (modified melasma area and severity index) | mMASI Score (modified melasma area and severity index); value 0-24; smaller score means better outcome | 3 months after taking the hyperthyroid drugs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melasma, modified melasma area and severity index, Thyroid stimulating hormone, Free thyroxine