Clinical trial NCT04346901: Comparative Study of mMASI Before and After Hyperthyroid Therapy in Hyperthyroid Subjects With Melasma
Official title: Comparative Study of mMASI Before and After Hyperthyroid Therapy in Hyperthyroid Subjects With Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melasma
Hyperthyroidism
Keywords: Melasma
modified melasma area and severity index
Thyroid stimulating hormone
Free thyroxine
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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

Primary outcomes:
measure: mMASI (modified melasma area and severity index)
timeFrame: 3 months after taking the hyperthyroid drugs
Secondary outcomes:
Other outcomes:
measure: Proportion of melasma in hyperthyroid patients
timeFrame: 3 months
Locations:
city: Jakarta
country: Indonesia
facility: dr. Cipto Mangunkusumo Hospital
state: Jakarta Pusat
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Irma B Sitohang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: