Clinical Trial: Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Therapy Using 1,064 nm and 595 nm
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Laser Therapy Using 1,064 nm and 595 nm on Patients With Melasma: A Prospective, Multi-center, Split Face, 2% Hydroquin
Brief Summary: This is a prospective, multi-center, split-face, controlled clinical trial that aims to investigate the efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet laser laser therapy on patients with melasma, compared with 2% hydroquinone cream. The trial will be performed by two Korean institutions on 45 subjects.
Detailed Summary:
Sponsor: LUTRONIC Corporation
Current Primary Outcome: Success rate of treatment according to RL*I [ Time Frame: Baseline, 1 week after final treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Relative skin lightness using the colorimeter(RL*I) [ Time Frame: Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment ]
- mMASI (modified Melasma Area Severity Index) evaluation [ Time Frame: Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment ]
- Subject satisfaction (5-point scale questionnaires on subject's satisfaction) [ Time Frame: 1 week and 12 weeks after the final treatment ]
Original Secondary Outcome: Same as current
Information By: LUTRONIC Corporation
Dates:
Date Received: January 24, 2017
Date Started: March 9, 2016
Date Completion:
Last Updated: January 30, 2017
Last Verified: January 2017