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.

Study Overview

• Status: Completed
• Conditions: Hyperthyroidism; Melasma
• Intervention / Treatment: Drug: Thiamazol

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta Pusat
    • Jakarta, Jakarta Pusat, Indonesia, 10430
      • Dr. Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Intervention; Before-and-After type of research	Drug: Thiamazol; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of melasma in hyperthyroid patients	Melasma proportion in hyperthyroid patients who visited the policlinics	3 months

Collaborators and Investigators

• Sponsor: Dr.dr.Irma Bernadette, SpKK (K)
• Investigators: Principal Investigator: Irma B Sitohang, MD, PhD, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): January 27, 2020
• Study Completion (Actual): February 15, 2020

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Melasma; modified melasma area and severity index; Thyroid stimulating hormone; Free thyroxine
• Additional Relevant MeSH Terms: Skin Diseases; Endocrine System Diseases; Thyroid Diseases; Hyperpigmentation; Pigmentation Disorders; Hyperthyroidism; Melanosis; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Antithyroid Agents; Methimazole
• Other Study ID Numbers: TesBN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No