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

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

• Status: Completed
• Conditions: Melasma; Picoseconds Laser
• Intervention / Treatment: Device: Fractional Picosecond 1,064 nm laser; Drug: 4% hydroquinone cream

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Mae Fah Luang University Hospital

Publications and helpful links

General Publications

• Ho C, Nguyen Q, Lowe NJ, Griffin ME, Lask G. Laser resurfacing in pigmented skin. Dermatol Surg. 1995 Dec;21(12):1035-7. doi: 10.1111/j.1524-4725.1995.tb00554.x.
• Weiss M, Weiss R, Lorden F, Trageser M, Beasley K. Picosecond laser for reduction of wrinkles: Long term results. Lasers Surg Med 2015; 47(S26): 24 (Abstract #68).

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Radiation-Protective Agents; Hydroquinone
• Other Study ID Numbers: 087/2559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No