Clinical trial NCT06780644: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Melasma
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 56
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Women
* Diagnosed with melasma based on clinical and Wood's lamp examination
* 30-59 years old
* Skin type IV or V

Exclusion Criteria:

* 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.\*
* 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.

Primary outcomes:
measure: Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score
timeFrame: re-evaluation on day 28, 56 and day 84 of therapy
measure: Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA)
timeFrame: re-evaluation on day 84 of therapy
measure: Change of Melasma Severity based on Dermoscopy
timeFrame: re-evaluation on day 84 of therapy
measure: Change of Melasma Severity based on Wood's Lamp
timeFrame: re-evaluation on day 84 of therapy
measure: Compare Quality Of Life based on MelasQoL Score
timeFrame: re-evaluation on day 28, 56 and day 84 of therapy
measure: Change of Melanin Index Based on Mexameter
timeFrame: re-evaluation on day 28, 56 and day 84 of therapy
measure: Change of Erytema Index Based on Mexameter
timeFrame: re-evaluation on day 28, 56 and day 84 of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Central Jakarta
country: Indonesia
facility: Dr. Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
References: