Efficacy and Safety of Using Combination of 755-nm Picosecond Alexandrite Laser and 2% Hydroquinone Compared With 2% Hydroquinone Alone for the Treatment of Melasma: a Randomized Split-face Controlled Trial

Study Overview
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Brief Summary
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This study aims to assess the efficacy and safety of using combination of 755-nm picosecond alexandrite laser and 2% hydroquinone compared with 2% hydroquinone alone for the treatment of melasma: A randomized split-face controlled trial

Official Title
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Efficacy and Safety of Using Combination of 755-nm Picosecond Alexandrite Laser and 2% Hydroquinone Compared With 2% Hydroquinone Alone for the Treatment of Melasma: a Randomized Split-face Controlled Trial

Conditions
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Melasma

Intervention / Treatment
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* Device: 755-nm picosecond alexandrite laser with topical 2% hydroquinone
* Drug: topical 2% hydroquinone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both male and female age 18-60 years Melasma on both cheeks - epidermal or mixed type Fitzpatrick Skin type III-V Exclusion Criteria: History of retinoid or other keratolytic drugs used within 6 months before enrolled History of keloid photosensitivity Immunocompromised host

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: split face - left side<br> | Device: 755-nm picosecond alexandrite laser with topical 2% hydroquinone<br>* treatment one side of the face with 755-nm picosecond alexandrite laser with topical 2% hydroquinone<br>|
| Active Comparator: split face - right side<br> | Drug: topical 2% hydroquinone<br>* treatment one side of the face with topical 2% hydroquinone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified melasma area and severity index score(mMASI) - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma of using combination of 755-nm picosecond alexandrite laser and 2% hydroquinone | score range 0-24 | 6 months | 
| Melanin index measured by Mexameter® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma | measuring in au | 6 months | 
| Average melanin measured by Antera3D® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma | measuring in au | 6 months | 
| Patient satisfaction quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma | score 0 -100% | 6 months | 
| Physician evaluation quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma | score 0 -100% | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of using combination of 755-nm picosecond alexandrite laser | Monitor side effect from picesecond alexandrite laser | 6 months | 
| Safety of using 2% hydroquinone | side effect of topical 2%Hydroquinone use | 6 months |