Comparative Study of mMASI Before and After Hyperthyroid... | NCT04346901

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

NCT04346901

Sponsor

Dr.dr.Irma Bernadette, SpKK (K)

Status

Completed

Last Update Posted

May 6, 2020Actual

Enrollment

23Actual

Phase

Phase 1

Conditions

Melasma
Hyperthyroidism

Interventions

Thiamazol

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Jan 27, 2020Actual

Completion Date

Feb 15, 2020Actual

First Submitted Date

Apr 10, 2020

First Submission Date that Met QC Criteria

Apr 13, 2020

First Posted Date

Apr 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2020

Last Update Posted Date

May 6, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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 UniversitySponsor-Investigator

Lead Sponsor

Dr.dr.Irma Bernadette, SpKK (K)OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Intervention	Other	Before-and-After type of research	Drug: Thiamazol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Proportion of melasma in hyperthyroid patients	Melasma proportion in hyperthyroid patients who visited the policlinics	3 months

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Irma B Sitohang, MD, PhD	Fakultas Kedokteran Universitas Indonesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
dr. Cipto Mangunkusumo Hospital		Jakarta	Jakarta Pusat	10430	Indonesia

Condition Browse Module

MeSH Terms

ID	Term
D008548	Melanosis
D006980	Hyperthyroidism

Ancestor Terms

ID	Term
D017495	Hyperpigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008713	Methimazole

Ancestor Terms

ID	Term
D013438	Sulfhydryl Compounds
D013457	Sulfur Compounds
D009930	Organic Chemicals
D007093	Imidazoles

Browse Leaves

Not provided

Browse Branches

Not provided