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

Phase 2

Completed

• Conditions: Melasma; Picoseconds Laser
• Interventions: Device: Fractional Picosecond 1,064 nm laser; Drug: 4% hydroquinone cream

• Registration Number: NCT03049059
• Lead Sponsor: Mae Fah Luang University Hospital

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

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2016-12-01
• Status Verified: 2017-02
• Study Completion: 2017-02-01
• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-07
• Study First Posted: 2017-02-09
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream	Fractional Picosecond 1,064 nm laser	-
Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream	4% hydroquinone cream	-
4% hydroquinone cream alone	4% hydroquinone cream	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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