Clinical Trial: 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 Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
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 Summary:
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
Sponsor: Mae Fah Luang University Hospital
Current Primary Outcome:
- Modified MASI score [ Time Frame: The mean change from the baseline to week-12 visit ]
- Proportion of subjects with at least 50% MASI score improvement [ Time Frame: from baseline to 12-week visit ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mexameter Melanin index [ Time Frame: baseline, week 4, week 8 and week 12 ]
- Global satisfaction score by Quartile rating scale [ Time Frame: week 4, week 8 and week 12 ]
- Quality of life by DLQI [ Time Frame: at week 12 ]
Original Secondary Outcome: Same as current
Information By: Mae Fah Luang University Hospital
Dates:
Date Received: February 3, 2017
Date Started: June 1, 2016
Date Completion:
Last Updated: February 7, 2017
Last Verified: February 2017
