MelasmaNCT04359719
Comparison Between Free Thyroxine and Thyroid Stimulating Hormone Levels on Melasma Severity
An observational study of Melasma, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The objective of the study was to compare the level of serum FT4 and TSH in patients with mild melasma and moderate-severe melasma. The determination of melasma lesion could also be known by using Janus II facial analysis UV light and polarization light to analyze the pattern of hyperpigmentation on melasma. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Melasma
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Jul 2019to 26 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The target population is patients with melasma in Indonesia aged 20-50 years. Affordable population are patients with melasma who come to the Skin and Genital Clinic of RSCM aged 20-50 years in the study period.
Who may be able to join
- Age 20-50 years
- Melasma lesions on the facial area.
- Willing to be the subject of research and sign a letter of research approval after being given an explanation (informed consent)
Who cannot join
- Pregnancy
- History of thyroid disease
- Using drugs that can affect the thyroid (glucocorticoids, lithium, amiodarone, iodide, octreotide)
- Using hormonal contraception for the past 1 year
- Using anti-seizure drugs
- Using hormone replacement therapy (HRT)
- Brown spots on the face preceded by reddish spots
- Brown spots on the face preceded by contact with facial whitening ingredients (hydroquinone)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison Between Free Thyroxine and Thyroid Stimulating Hormone Levels on Melasma Severity: A Cross Sectional Study
The objective of the study was to compare the level of serum FT4 and TSH in patients with mild melasma and moderate-severe melasma. The determination of melasma lesion could also be known by using Janus II facial analysis UV light and polarization light to analyze the pattern of hyperpigmentation on melasma. This was a descriptive-analytic study used a cross-sectional method that was performed in 2019 at two different dermatology and venerology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta and Gatot Subroto Army Hospital Jakarta. Forty-eight subjects with melasma, 50% diagnosed with mild melasma and 50% with moderate-severe melasma according to the modified melasma area and severity index (mMASI) score. The level of serum FT4 and TSH were then measured in both groups of the patients.
Read the detailed description
Melasma has been suspected to be linked with thyroid hormone. There is no study that explains the association of thyroid hormone level with melasma severity.
This study aims to find the difference in the levels of thyroid hormone in varying severity of melasma.
This was a descriptive-analytic study used a cross-sectional method that was performed in 2019 at two different dermatology and venerology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta and Gatot Subroto Army Hospital Jakarta.
Forty eight patients participated in this study, 50% diagnosed with mild melasma and 50% with moderate-severe melasma. Subjects are chosen consecutively based on mMASI and Janus II measurement. The level of serum FT4 and TSH were then measured in both groups of the patients. The data is tabulated and a comparative analysis of serum FT4 and TSH levels with mild and moderate-severe melasma is done. In addition, this study also analyzes the level of serum FT4 and TSH with the result of Janus II facial analysis system scoring. The same method of analysis was done to know the association between mMASI and examination by using Janus II facial analysis system.
This study aims to find the difference in the levels of thyroid hormone in varying severity of melasma.
- Conditions
- Melasma
- Keywords
- mMASI, Janus II facial analysis system, TSH, FT4
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group mild melasma | This subjects according to the modified melasma area and severity index (mMASI) score. Variables that are measure by mMASI scoring includes the degree of darkness and involvement of area. Darkness component is used to replace pigmentation and intensity in MASI scoring with modification (mMASI). Assessment using mMASI is highly dependent on the operator; hence, a new objective examination to assess skin pigmentation have been developed, which is the facial imaging analysis. The level of serum FT4 and TSH were then measured in both groups of the patients. In addition, the degree of skin pigmentation was also measured by using the Janus II facial analysis system. In this study, there were two modalities used in the Janus II facial analysis system, which is the polarization light and ultraviolet light. In addition, this study also analyzes the level of serum FT4 and TSH with the result of Janus II facial analysis system scoring. | |
| Group Moderate-severe melasma | This subjects according to the modified melasma area and severity index (mMASI) score. Variables that are measure by mMASI scoring includes the degree of darkness and involvement of area. Darkness component is used to replace pigmentation and intensity in MASI scoring with modification (mMASI). Assessment using mMASI is highly dependent on the operator; hence, a new objective examination to assess skin pigmentation have been developed, which is the facial imaging analysis. The level of serum FT4 and TSH were then measured in both groups of the patients. In addition, the degree of skin pigmentation was also measured by using the Janus II facial analysis system. In this study, there were two modalities used in the Janus II facial analysis system, which is the polarization light and ultraviolet light. In addition, this study also analyzes the level of serum FT4 and TSH with the result of Janus II facial analysis system scoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
association of serum TSH and FT4 level with the severity degree of melasma
There are no association between the level of serum TSH and FT4 and various degrees of melasma
Measured: 2 weeks: 15 - 26 July 2019
Secondary outcomes (1)
The correlation of serum TSH and FT4 levels with the Janus facial analysis system
The correlation is only found between the level of serum FT4 and Janus polarization test
Measured: 2 weeks: 15 - 26 July 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start15 Jul 2019
- Primary completion26 Jul 2019
- Study completion26 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
- Investigators
- Irma B Sitohang, MD, PhD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359719
- Sponsor's protocol ID
- ThyrMel
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Between Free Thyroxine and Thyroid Stimulating Hormone Levels on Melasma Severity: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04359719
- Acronym / sponsor ID
- ThyrMel
- Conditions
- Melasma
- Keywords
- mMASI, Janus II facial analysis system, TSH, FT4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 26 Jul 2019 (actual)
- Study completion
- 26 Oct 2019 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study was to compare the level of serum FT4 and TSH in patients with mild melasma and moderate-severe melasma. The determination of melasma lesion could also be known by using Janus II facial analysis UV light and polarization light to analyze the pattern of hyperpigmentation on melasma. This was a descriptive-analytic study used a cross-sectional method that was performed in 2019 at two different dermatology and venerology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta and Gatot Subroto Army Hospital Jakarta. Forty-eight subjects with melasma, 50% diagnosed with mild melasma and 50% with moderate-severe melasma according to the modified melasma area and severity index (mMASI) score. The level of serum FT4 and TSH were then measured in both groups of the patients.
Detailed description
Melasma has been suspected to be linked with thyroid hormone. There is no study that explains the association of thyroid hormone level with melasma severity.
This study aims to find the difference in the levels of thyroid hormone in varying severity of melasma.
This was a descriptive-analytic study used a cross-sectional method that was performed in 2019 at two different dermatology and venerology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta and Gatot Subroto Army Hospital Jakarta.
Forty eight patients participated in this study, 50% diagnosed with mild melasma and 50% with moderate-severe melasma. Subjects are chosen consecutively based on mMASI and Janus II measurement. The level of serum FT4 and TSH were then measured in both groups of the patients. The data is tabulated and a comparative analysis of serum FT4 and TSH levels with mild and moderate-severe melasma is done. In addition, this study also analyzes the level of serum FT4 and TSH with the result of Janus II facial analysis system scoring. The same method of analysis was done to know the association between mMASI and examination by using Janus II facial analysis system.
This study aims to find the difference in the levels of thyroid hormone in varying severity of melasma.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group mild melasma | – | –This subjects according to the modified melasma area and severity index (mMASI) score. Variables that are measure by mMASI scoring includes the degree of darkness and involvement of area. Darkness component is used to replace pigmentation and intensity in MASI scoring with modification (mMASI). Assessment using mMASI is highly dependent on the operator; hence, a new objective examination to assess skin pigmentation have been developed, which is the facial imaging analysis. The level of serum FT4 and TSH were then measured in both groups of the patients. In addition, the degree of skin pigmentation was also measured by using the Janus II facial analysis system. In this study, there were two modalities used in the Janus II facial analysis system, which is the polarization light and ultraviolet light. In addition, this study also analyzes the level of serum FT4 and TSH with the result of Janus II facial analysis system scoring. |
| Group Moderate-severe melasma | – | –This subjects according to the modified melasma area and severity index (mMASI) score. Variables that are measure by mMASI scoring includes the degree of darkness and involvement of area. Darkness component is used to replace pigmentation and intensity in MASI scoring with modification (mMASI). Assessment using mMASI is highly dependent on the operator; hence, a new objective examination to assess skin pigmentation have been developed, which is the facial imaging analysis. The level of serum FT4 and TSH were then measured in both groups of the patients. In addition, the degree of skin pigmentation was also measured by using the Janus II facial analysis system. In this study, there were two modalities used in the Janus II facial analysis system, which is the polarization light and ultraviolet light. In addition, this study also analyzes the level of serum FT4 and TSH with the result of Janus II facial analysis system scoring. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The target population is patients with melasma in Indonesia aged 20-50 years. Affordable population are patients with melasma who come to the Skin and Genital Clinic of RSCM aged 20-50 years in the study period.
Key inclusion criteria (3 listed)
- Age 20-50 years
- Melasma lesions on the facial area.
- Willing to be the subject of research and sign a letter of research approval after being given an explanation (informed consent)
Key exclusion criteria (8 listed)
- Pregnancy
- History of thyroid disease
- Using drugs that can affect the thyroid (glucocorticoids, lithium, amiodarone, iodide, octreotide)
- Using hormonal contraception for the past 1 year
- Using anti-seizure drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
association of serum TSH and FT4 level with the severity degree of melasma
Time frame: 2 weeks: 15 - 26 July 2019
There are no association between the level of serum TSH and FT4 and various degrees of melasma
1 secondary outcome
The correlation of serum TSH and FT4 levels with the Janus facial analysis system
Time frame: 2 weeks: 15 - 26 July 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irma B Sitohang, MD, PhD principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melasma, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association of serum TSH and FT4 level with the severity degree of melasma (time frame: 2 weeks: 15 - 26 July 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.