Melasma, Picoseconds Laser
Conditions
Brief summary
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
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
Interventions
Fractional Picosecond 1,064 nm laser and daily application with 4% hydroquinone cream
DRUG4% hydroquinone cream
Sponsors
Mae Fah Luang University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized split face
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed