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

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

Sponsors

Lead Sponsor: Dr.dr.Irma Bernadette, SpKK (K)

Source Indonesia University
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

Overall Status Completed
Start Date 2019-08-01
Completion Date 2020-02-15
Primary Completion Date 2020-01-27
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
mMASI (modified melasma area and severity index) 3 months after taking the hyperthyroid drugs
Enrollment 23
Condition
Intervention

Intervention Type: Drug

Intervention Name: Thiamazol

Description: 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

Arm Group Label: Single Intervention

Eligibility

Criteria:

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

Gender:

Female

Gender Based:

Yes

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Irma B Sitohang, MD, PhD Principal Investigator Fakultas Kedokteran Universitas Indonesia
Location
Facility: dr. Cipto Mangunkusumo Hospital
Location Countries

Indonesia

Verification Date

2020-05-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Indonesia University

Investigator Full Name: Dr.dr.Irma Bernadette, SpKK (K)

Investigator Title: Irma Bernadette S. Sitohang, MD, PhD - Head of Division of Cosmetic Dermatology, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Single Intervention

Type: Other

Description: Before-and-After type of research

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

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