A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma

Study Overview
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Brief Summary
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A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma

Detailed Description
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Primary Objective: To compare clinical efficacy by Modified MASI score between Fractional Picosecond 1,064 nm laser and daily application of 4% hydroquinone with 4% hydroquinone alone Secondary objectives To compare the clinical endpoints of Mexameter Melanin Index, brownish spot and Ultraviolet spots by VISIATM complexion analysis, The Antera 3D® imaging technology for pigmentation, quality of life by Dermatology Life Quality Index and patient's satisfaction between Fractional Picosecond 1,064 nm laser and 4% hydroquinone with 4% hydroquinone alone

Official Title
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A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma

Conditions
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Picoseconds Laser, Melasma

Intervention / Treatment
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* Device: Fractional Picosecond 1,064 nm laser
* Drug: 4% hydroquinone cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female with melasma lesion on bilateral sides Age between 18-65 years Dermal or mixed type melasma, confirming by Wood's lamp test Willing to participant in this study and signed in informed consent form Exclusion Criteria: Pregnancy / lactation Having an activity or working outside the building or unable to avoid heavy UV light Allergic to UV sunscreen, topical anesthetics , topical corticosteroid or hydroquinone Treatment with laser or chemical peeling within 3 months Treatment with Skin Lighting medication / food supplements within 4 weeks Currently use of topical retinoid, hydroquinone or corticosteroid within 4 weeks Use of whitening cream such as alpha arbutin, azelaic acid, kojic acid ascorbic acid or any cosmetics within 2 weeks Uncontrolled medical illness include non-skin cancers, coagulopathy Intra-cardiac device - pacemaker Photosentive conditions such as diabetes, thyroid disease, liver and kidney disease and photosensitive dermatosis Currently taking anticoagulant such as warfarin Active skin infection or acute dermatitis at testes skin sites Unable to follow and comply to the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized split face
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream<br> | Device: Fractional Picosecond 1,064 nm laser<br>* Fractional Picosecond 1,064 nm laser and daily application with 4% hydroquinone cream<br>Drug: 4% hydroquinone cream<br> <br> |
| Active Comparator: 4% hydroquinone cream alone<br> | Drug: 4% hydroquinone cream<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified MASI score |  | The mean change from the baseline to week-12 visit | 
| Proportion of subjects with at least 50% MASI score improvement |  | from baseline to 12-week visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mexameter Melanin index |  | baseline, week 4, week 8 and week 12 | 
| Global satisfaction score by Quartile rating scale |  | week 4, week 8 and week 12 | 
| Quality of life by DLQI |  | at week 12 |