Back to resultsComparative Study of mMASI Before and After Hyperthyroid Therapy in Hyperthyroid Subjects With Melasma
Primary Purpose
Melasma, Hyperthyroidism
Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Thiamazol
Sponsored by
About this trial
This is an interventional other trial for Melasma focused on measuring Melasma, modified melasma area and severity index, Thyroid stimulating hormone, Free thyroxine
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
Sites / Locations
- dr. Cipto Mangunkusumo Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Intervention
Arm Description
Before-and-After type of research
Outcomes
Primary Outcome Measures
mMASI (modified melasma area and severity index)
mMASI Score (modified melasma area and severity index); value 0-24; smaller score means better outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT04346901
First Posted
April 10, 2020
Last Updated
May 5, 2020
Sponsor
Dr.dr.Irma Bernadette, SpKK (K)
1. Study Identification
Unique Protocol Identification Number
NCT04346901
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 27, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr.dr.Irma Bernadette, SpKK (K)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma, Hyperthyroidism
Keywords
Melasma, modified melasma area and severity index, Thyroid stimulating hormone, Free thyroxine
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Intervention
Arm Type
Other
Arm Description
Before-and-After type of research
Intervention Type
Drug
Intervention Name(s)
Thiamazol
Intervention Description
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
Primary Outcome Measure Information:
Title
mMASI (modified melasma area and severity index)
Description
mMASI Score (modified melasma area and severity index); value 0-24; smaller score means better outcome
Time Frame
3 months after taking the hyperthyroid drugs
Other Pre-specified Outcome Measures:
Title
Proportion of melasma in hyperthyroid patients
Description
Melasma proportion in hyperthyroid patients who visited the policlinics
Time Frame
3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irma B Sitohang, MD, PhD
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
dr. Cipto Mangunkusumo Hospital
City
Jakarta
State/Province
Jakarta Pusat
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
Comparative Study of mMASI Before and After Hyperthyroid Therapy in Hyperthyroid Subjects With Melasma
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