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Completed

NCT Number: NCT04346901

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

dr. Cipto Mangunkusumo Hospital

Jakarta, Jakarta Pusat, 10430, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thiamazol

Drug

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

Primary outcomes

  1. mMASI (modified melasma area and severity index)

    Time frame: 3 months after taking the hyperthyroid drugs

    mMASI Score (modified melasma area and severity index); value 0-24; smaller score means better outcome

Other outcomes

  1. Proportion of melasma in hyperthyroid patients

    Time frame: 3 months

    Melasma proportion in hyperthyroid patients who visited the policlinics

Sponsors and collaborators

Lead sponsor

Dr.dr.Irma Bernadette, SpKK (K)

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2020
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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