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

Mae Fah Luang University Hospital

Status and phase: Completed; Phase 2

Conditions: Melasma; Picoseconds Laser

Treatments: Device: Fractional Picosecond 1,064 nm laser; Drug: 4% hydroquinone cream

Study type: Interventional

Funder types: Other

Identifiers

NCT03049059

087/2559

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream

Experimental group

Treatment:

Drug: 4% hydroquinone cream

Device: Fractional Picosecond 1,064 nm laser

4% hydroquinone cream alone

Active Comparator group

Treatment:

Drug: 4% hydroquinone cream