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

NCT04346901 | Completed Phase 1

• 1 other identifier: TesBN
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma; Hyperthyroidism

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Proportion of melasma in hyperthyroid patients

  3 months

Study Arms (1)

Single Intervention

OTHER

Before-and-After type of research

Drug: Thiamazol

Interventions

Thiamazol DRUG

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

Single Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female with age range of 18 to 60 years old
• Newly diagnosed with hyperthyroid on a laboratory basis
• Diagnosed with melasma by dermatologist

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr.dr.Irma Bernadette, SpKK (K): lead

Study Sites (1)

dr. Cipto Mangunkusumo Hospital

Jakarta, Jakarta Pusat, 10430, Indonesia

Location

MeSH Terms

Conditions

Melanosis; Hyperthyroidism

Interventions

Methimazole

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Irma B Sitohang, MD, PhD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI 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

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 15, 2020
• Study Start: August 1, 2019
• Primary Completion: January 27, 2020
• Study Completion: February 15, 2020
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

ID (1)