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

Sponsor
Dr.dr.Irma Bernadette, SpKK (K) (Other)
Overall Status
Completed
CT.gov ID
NCT04346901
Collaborator
(none)
23
1
1
6.5
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Comparative Study of mMASI Before and After Hyperthyroid Therapy in Hyperthyroid Subjects With Melasma
Actual Study Start Date :
Aug 1, 2019
Actual Primary Completion Date :
Jan 27, 2020
Actual Study Completion Date :
Feb 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Single Intervention

Before-and-After type of research

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

Outcome Measures

Primary Outcome Measures

  1. mMASI (modified melasma area and severity index) [3 months after taking the hyperthyroid drugs]

    mMASI Score (modified melasma area and severity index); value 0-24; smaller score means better outcome

Other Outcome Measures

  1. Proportion of melasma in hyperthyroid patients [3 months]

    Melasma proportion in hyperthyroid patients who visited the policlinics

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 dr. Cipto Mangunkusumo Hospital Jakarta Jakarta Pusat Indonesia 10430

Sponsors and Collaborators

  • Dr.dr.Irma Bernadette, SpKK (K)

Investigators

  • Principal Investigator: Irma B Sitohang, MD, PhD, Fakultas Kedokteran Universitas Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr.dr.Irma Bernadette, SpKK (K), 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, Indonesia University
ClinicalTrials.gov Identifier:
NCT04346901
Other Study ID Numbers:
  • TesBN
First Posted:
Apr 15, 2020
Last Update Posted:
May 6, 2020
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr.dr.Irma Bernadette, SpKK (K), 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, Indonesia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2020