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 ]

The success rate is determined by the change rate (%) of the relative lightness measured before the treatment (day of screening) and 1 week after the 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