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
Women
Diagnosed with melasma based on clinical and Wood's lamp examination
30-59 years old
Skin type IV or V
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.
Parallel
Triple combination cream
Drug1. 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.
Triple combination cream
Drug1. 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
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%
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
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.
Change of Melasma Severity based on Wood's Lamp
Epidermal Type/ Dermal Typed/ Mixed Typed
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