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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04346901
Enrollment
23
Registered
2020-04-15
Start date
2019-08-01
Completion date
2020-02-15
Last updated
2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperthyroidism, Melasma

Keywords

Melasma, modified melasma area and severity index, Thyroid stimulating hormone, Free thyroxine

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

Interventions

DRUGThiamazol

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

Sponsors

Dr.dr.Irma Bernadette, SpKK (K)
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
mMASI (modified melasma area and severity index)3 months after taking the hyperthyroid drugsmMASI Score (modified melasma area and severity index); value 0-24; smaller score means better outcome

Other

MeasureTime frameDescription
Proportion of melasma in hyperthyroid patients3 monthsMelasma proportion in hyperthyroid patients who visited the policlinics

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026