MelasmaNCT06780644
Comparison of Effectiveness and Safety of Triple Combination Cream of Fucinolone Acetonide 0.01%, Hydroquinone 4%, Tretinoin 0.05% with Mometasone Furoate 0.1%, Hydroquinone 4%, Tretinoin 0.05% in the Treatment of Melasma
A study testing Triple combination cream in people with Melasma, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This Research is a clinical study with a single-blind randomized controlled trial of evaluators. Clinical trial Randomized Controlled Trial (RCT) design that compares the use of a triple combination cream of flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% with a triple cream combination of mometasone… Read more about this study
- Who is it for?
- Ages 30 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Triple combination cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Feb 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- Diagnosed with melasma based on clinical and Wood's lamp examination
- 30-59 years old
- Skin type IV or V
Who cannot join
- Plan to be pregnant and breastfeeding women during the study period ( 12 weeks)
- using or have used hormonal contraception in the last 6 months, or plan to use hormonal contraception during the study period (12 weeks)
- Using topical melasma treatments such as corticosteroids, tretinoin, hydroquinone, and other skin whitening or lightening treatments in at least the last 2 weeks.
- Have used topical therapy for melasma i.e. triple combination cream for at least 3 months and showed no significant improvement.
- Using systemic therapy for melasma, e.g. antioxidants, tranexamic acid in at least the last 4 weeks.*
- History of eppeeling, laser or mechanical abrasion on the face in the last 6 months.*
Show all 9Show fewer
- Using photosensitizer drugs such as tetracycline, phenytoin, carbamazepine, and spironolactone in at least the last 4 weeks.
- Having other skin complaints that may interfere with the evaluation of melasma such as post-inflammatory hyperpigmentation, Hori nevus, Ota nevus, pigmented contact dermatitis, and other pigmentation disorders.
- Difficulty in adherence to treatment such as long distance from home, work schedules, and busy activities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Dr. Cipto Mangunkusumo Hospital
Central Jakarta, DKI Jakarta, 10430
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K), +62818130761, irma_bernadette@yahoo.com
About this study
This Research is a clinical study with a single-blind randomized controlled trial of evaluators. Clinical trial Randomized Controlled Trial (RCT) design that compares the use of a triple combination cream of flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% with a triple cream combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05% in melasma therapy in RSCM-FKUI.
This study aims to Assess the effectiveness and safety of Triple Combination Cream of Fucinolone Acetonide 0.01%, Hydroquinone 4%, Tretinoin 0.05% with Mometasone Furoate 0.1%, Hydroquinone 4%, Tretinoin 0.05% in melasma patients
Read the detailed description
Melasma is a skin pigmentation disorder characterized by macules or brownish patches on the face. Melasma is mostly found in women of productive age especially with Fitzpatrick skin type IV or V. Melasma is dominated by women, with the ratio of women to men being 9-10:1.4 Based on data from the Dermatology and Venereology polyclinic of Dr. Cipto Mangunkusumo Hospital, the proportion of melasma patient visits in 2022 was 1.17% of all new visits and all were female.
There are various treatment options for melasma which include sun protection, lightening medications, exfoliatives, antioxidants, resurfacing procedures, laser procedures, and light-based therapies. First-line treatments for melasma include sun protection and topical lightening medications. Topical brighteners that have become the gold standard of melasma therapy are triple combination creams and single hydroquinone. With 8-12 weeks of use, evidence has shown that a combination of compounds containing 4% hydroquinone, tretinoin, and steroids or triple cream produces a better therapeutic response than single hydroquinone.
Majid (2010) found that most patients (51.7%) had used mometasone-based triple-drug combination treatment beyond the recommended duration.
This research is a study using a Randomized Controlled Trial (RCT) design that compares the use of a triple combination cream of flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% with a triple cream combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05% This study was single-blind randomized to investigators. Research subjects were randomized to determine the group for a triple combination cream of flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% and a triple cream combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05%. Subjects will be divided into 28 people per group.
The research evaluation time is 12 weeks. The triple combination cream of flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% group (A) and the triple cream combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05% group (B)
. all SP groups A, and B will undergo an initial physical examination in the form of a physical examination, clinical photos, mMASI score, MelasQOL-INA, dermoscopy, Wood's lamp, and mexameter.
Group A or B evaluation will be carried out every 4 weeks, namely weeks 0, 4, 8, 12. Subjects were given facial wash, sunscreen, and triple combination for the night Each evaluation will be checked: Physical examination , mMASI score, PtGA, mexameter examination Data is recorded in the research status which is then compiled into a master table, inputted into Ms Excel, and analyzed using SPSS for windows version 25.0. The results of the study were displayed in the form of narratives, tables, and graphs. Categorical data were presented in frequencies and percentages. Numerical data were presented as mean and standard deviation if normal data distribution was obtained or median and minimum-maximum values if abnormal data distribution was obtained.
The Pearson test is used to assess the correlation between mMASI and MELASQoL-INA scores if a normal data distribution is obtained, while the Spearman test is used if the data distribution is not normal. The test results obtained are in the form of a correlation coefficient (r) which is in the range -1 and 1. The r value which is in the range 0.1-0.3 indicates the correlation between the two variables is weak, the range 0.4-0.6 indicates a moderate correlation , a range of 0.6-0.9 indicates a strong correlation, and 1 indicates a perfect correlation. The value of statistical significance in the research is determined.
- Conditions
- Melasma
- Being tested
- Triple combination cream
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple combination creamDrug
- Apply sunscreen SPF ≥30 in the morning on 2 knuckles
- Apply triple combination cream containing hydroquinone 40 mg, tretinoin 0.5 mg, and fluocinolone acetonide 0.1 mg at night all over the face except the area around the eyes, 1 fingertip unit (FTU) or 1 knuckle.
Triple combination creamDrug
- Apply sunscreen SPF ≥30 in the morning on 2 knuckles
- Apply triple combination cream containing mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05% at night all over the face except the area around the eyes, 1 fingertip unit (FTU) or 1 knuckle
| Study group | Role | What they receive |
|---|---|---|
| Group A ( Triple combination Group) | Experimental | Group A, The treatment group, getting sunscreen cream in the morning and triple combination flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream at night and facial soap that can be used in the morning and evening. Receives: Drug: Triple combination cream |
| Group B (Triple Combination Group) | Experimental | Group B, the treatment group, getting sunscreen cream in the morning and triple combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05%, cream at night and facial soap that can be used in the morning and evening. Receives: Drug: Triple combination cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score
The range of values for mMASI is between 0 and 24 which can then be divided into mild melasma (0-8), moderate (8-16), and severe (16-24). improvement occurs if the mMASI score decreases by <50% from the previous visit worsening if score persists or mMASI Score Increase >50%
Measured: re-evaluation on day 28, 56 and day 84 of therapy
Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA)
one method of evaluating the response to therapy in melasma which is assessed subjectively by the patient. The response to therapy can be assessed as follows No or slight response: < 25% improvement Moderate response: 25% - 50% improvement Good response: 50% improvement - < 75% Excellent response: improvement > 75% The response is said to be good if the score is above 50% since the previous visit
Measured: re-evaluation on day 84 of therapy
Change of Melasma Severity based on Dermoscopy
based on Dermoscopy Telangiectasis score assessment using a 5-point dermoscopy-scale: 0 = No visible capillaries. 1 = Elongated capillaries accompanied by dilation, not visible to the naked eye. 2 = Moderate telangiectasis that is beginning to be visible to the naked eye. 3 = Severe telangiectasis characterized by reduced capillary loops. 4 = Very severe telangiectasis characterized by dilatation and loss of capillary loops.
Measured: re-evaluation on day 84 of therapy
Change of Melasma Severity based on Wood's Lamp
Epidermal Type/ Dermal Typed/ Mixed Typed
Measured: re-evaluation on day 84 of therapy
Compare Quality Of Life based on MelasQoL Score
based on MelasQoL Score minimum score: 7 maximum score : 70
Measured: re-evaluation on day 28, 56 and day 84 of therapy
Change of Melanin Index Based on Mexameter
improves if there is a decrease in melanin levels > 50% from the initial visit It is said to be bad or persistent if there is no decrease in melanin levels or there is a decrease of <50%
Measured: re-evaluation on day 28, 56 and day 84 of therapy
Change of Erytema Index Based on Mexameter
improves if there is a decrease in Erytema levels > 50% from the initial visit It is said to be bad or persistent if there is no decrease in erythema levels or there is a decrease of <50%
Measured: re-evaluation on day 28, 56 and day 84 of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start17 Feb 2025 (estimated)
- Primary completion26 May 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
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.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780644
- Sponsor's protocol ID
- triple combination cream
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness and Safety of Triple Combination Cream of Fucinolone Acetonide 0.01%, Hydroquinone 4%, Tretinoin 0.05% with Mometasone Furoate 0.1%, Hydroquinone 4%, Tretinoin 0.05% in the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT06780644
- Acronym / sponsor ID
- triple combination cream
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 17 Feb 2025 (estimated)
- Primary completion
- 26 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 17 Jan 2025 (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.
This Research is a clinical study with a single-blind randomized controlled trial of evaluators. Clinical trial Randomized Controlled Trial (RCT) design that compares the use of a triple combination cream of flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% with a triple cream combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05% in melasma therapy in RSCM-FKUI.
This study aims to Assess the effectiveness and safety of Triple Combination Cream of Fucinolone Acetonide 0.01%, Hydroquinone 4%, Tretinoin 0.05% with Mometasone Furoate 0.1%, Hydroquinone 4%, Tretinoin 0.05% in melasma patients
Detailed description
Melasma is a skin pigmentation disorder characterized by macules or brownish patches on the face. Melasma is mostly found in women of productive age especially with Fitzpatrick skin type IV or V. Melasma is dominated by women, with the ratio of women to men being 9-10:1.4 Based on data from the Dermatology and Venereology polyclinic of Dr. Cipto Mangunkusumo Hospital, the proportion of melasma patient visits in 2022 was 1.17% of all new visits and all were female.
There are various treatment options for melasma which include sun protection, lightening medications, exfoliatives, antioxidants, resurfacing procedures, laser procedures, and light-based therapies. First-line treatments for melasma include sun protection and topical lightening medications. Topical brighteners that have become the gold standard of melasma therapy are triple combination creams and single hydroquinone. With 8-12 weeks of use, evidence has shown that a combination of compounds containing 4% hydroquinone, tretinoin, and steroids or triple cream produces a better therapeutic response than single hydroquinone.
Majid (2010) found that most patients (51.7%) had used mometasone-based triple-drug combination treatment beyond the recommended duration.
This research is a study using a Randomized Controlled Trial (RCT) design that compares the use of a triple combination cream of flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% with a triple cream combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05% This study was single-blind randomized to investigators. Research subjects were randomized to determine the group for a triple combination cream of flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% and a triple cream combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05%. Subjects will be divided into 28 people per group.
The research evaluation time is 12 weeks. The triple combination cream of flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% group (A) and the triple cream combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05% group (B)
. all SP groups A, and B will undergo an initial physical examination in the form of a physical examination, clinical photos, mMASI score, MelasQOL-INA, dermoscopy, Wood's lamp, and mexameter.
Group A or B evaluation will be carried out every 4 weeks, namely weeks 0, 4, 8, 12. Subjects were given facial wash, sunscreen, and triple combination for the night Each evaluation will be checked: Physical examination , mMASI score, PtGA, mexameter examination Data is recorded in the research status which is then compiled into a master table, inputted into Ms Excel, and analyzed using SPSS for windows version 25.0. The results of the study were displayed in the form of narratives, tables, and graphs. Categorical data were presented in frequencies and percentages. Numerical data were presented as mean and standard deviation if normal data distribution was obtained or median and minimum-maximum values if abnormal data distribution was obtained.
The Pearson test is used to assess the correlation between mMASI and MELASQoL-INA scores if a normal data distribution is obtained, while the Spearman test is used if the data distribution is not normal. The test results obtained are in the form of a correlation coefficient (r) which is in the range -1 and 1. The r value which is in the range 0.1-0.3 indicates the correlation between the two variables is weak, the range 0.4-0.6 indicates a moderate correlation , a range of 0.6-0.9 indicates a strong correlation, and 1 indicates a perfect correlation. The value of statistical significance in the research is determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A ( Triple combination Group) | Experimental | Drug: Triple combination creamGroup A, The treatment group, getting sunscreen cream in the morning and triple combination flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream at night and facial soap that can be used in the morning and evening. |
| Group B (Triple Combination Group) | Experimental | Drug: Triple combination creamGroup B, the treatment group, getting sunscreen cream in the morning and triple combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05%, cream at night and facial soap that can be used in the morning and evening. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women
- Diagnosed with melasma based on clinical and Wood's lamp examination
- 30-59 years old
- Skin type IV or V
Key exclusion criteria (9 listed)
- Plan to be pregnant and breastfeeding women during the study period ( 12 weeks)
- using or have used hormonal contraception in the last 6 months, or plan to use hormonal contraception during the study period (12 weeks)
- Using topical melasma treatments such as corticosteroids, tretinoin, hydroquinone, and other skin whitening or lightening treatments in at least the last 2 weeks.
- Have used topical therapy for melasma i.e. triple combination cream for at least 3 months and showed no significant improvement.
- Using systemic therapy for melasma, e.g. antioxidants, tranexamic acid in at least the last 4 weeks.*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple combination cream1. Apply sunscreen SPF ≥30 in the morning on 2 knuckles 2. Apply triple combination cream containing hydroquinone 40 mg, tretinoin 0.5 mg, and fluocinolone acetonide 0.1 mg at night all over the face except the area around the eyes, 1 fingertip unit (FTU) or 1 knuckle. | Drug | Group A ( Triple combination Group) |
| Triple combination cream1. Apply sunscreen SPF ≥30 in the morning on 2 knuckles 2. Apply triple combination cream containing mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05% at night all over the face except the area around the eyes, 1 fingertip unit (FTU) or 1 knuckle | Drug | Group B (Triple Combination Group) |
Primary outcome
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score
Time frame: re-evaluation on day 28, 56 and day 84 of therapy
The range of values for mMASI is between 0 and 24 which can then be divided into mild melasma (0-8), moderate (8-16), and severe (16-24). improvement occurs if the mMASI score decreases by <50% from the previous visit worsening if score persists or mMASI Score Increase >50%
Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA)
Time frame: re-evaluation on day 84 of therapy
one method of evaluating the response to therapy in melasma which is assessed subjectively by the patient. The response to therapy can be assessed as follows No or slight response: < 25% improvement Moderate response: 25% - 50% improvement Good response: 50% improvement - < 75% Excellent response: improvement > 75% The response is said to be good if the score is above 50% since the previous visit
Change of Melasma Severity based on Dermoscopy
Time frame: re-evaluation on day 84 of therapy
based on Dermoscopy Telangiectasis score assessment using a 5-point dermoscopy-scale: 0 = No visible capillaries. 1 = Elongated capillaries accompanied by dilation, not visible to the naked eye. 2 = Moderate telangiectasis that is beginning to be visible to the naked eye. 3 = Severe telangiectasis characterized by reduced capillary loops. 4 = Very severe telangiectasis characterized by dilatation and loss of capillary loops.
Change of Melasma Severity based on Wood's Lamp
Time frame: re-evaluation on day 84 of therapy
Epidermal Type/ Dermal Typed/ Mixed Typed
Compare Quality Of Life based on MelasQoL Score
Time frame: re-evaluation on day 28, 56 and day 84 of therapy
based on MelasQoL Score minimum score: 7 maximum score : 70
Change of Melanin Index Based on Mexameter
Time frame: re-evaluation on day 28, 56 and day 84 of therapy
improves if there is a decrease in melanin levels > 50% from the initial visit It is said to be bad or persistent if there is no decrease in melanin levels or there is a decrease of <50%
Change of Erytema Index Based on Mexameter
Time frame: re-evaluation on day 28, 56 and day 84 of therapy
improves if there is a decrease in Erytema levels > 50% from the initial visit It is said to be bad or persistent if there is no decrease in erythema levels or there is a decrease of <50%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple combination cream in people with 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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 17 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) (+62818130761, irma_bernadette@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score (time frame: re-evaluation on day 28, 56 and day 84 of therapy). The study lists 7 primary outcomes in all. 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 17 Jan 2025.