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

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346901
• Other study ID #: TesBN
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2019
• Est. completion date: February 15, 2020

Study information

• Verified date: May 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 15, 2020
• Est. primary completion date: January 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperthyroidism
• Melanosis
• Melasma

Intervention

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

Locations

Country	Name	City	State
Indonesia	dr. Cipto Mangunkusumo Hospital	Jakarta	Jakarta Pusat

Sponsors (1)

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

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of melasma in hyperthyroid patients	Melasma proportion in hyperthyroid patients who visited the policlinics	3 months
Primary	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