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

Phase 1

Completed

• Conditions: Melasma; Hyperthyroidism
• Interventions: Drug: Thiamazol

• Registration Number: NCT04346901
• Lead Sponsor: Dr.dr.Irma Bernadette, SpKK (K)

Brief Summary

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

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 Timeline

• Study Start: 2019-08-01
• Primary Completion: 2020-01-27
• Study Completion: 2020-02-15
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-15
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-05
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Intervention	Thiamazol	Before-and-After type of research

Primary Outcome Measures

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

Trial Locations

Locations (1)

dr. Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta, Jakarta Pusat, Indonesia