Clinical Trial: A Single-Center 2-Arm Study for Lentigines on the Hands
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: A Single-Center 2-Arm Study of the Enlighten and Excel V Laser for Lentigines on the Hands
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of two laser systems for improvement of lentigines on the hands.
Detailed Summary: The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of two laser systems for the treatment of lentigines (liver spots, age spots, or dark sun spots) on the hands.
Sponsor: Cutera Inc.
Current Primary Outcome: Percent reduction in the number of hand lentigines at 4 weeks post-final treatment as assessed by blinded reviewers. [ Time Frame: Four weeks post final laser treatment. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Degree of improvement in overall appearance of the hands at 4 weeks post-final treatment as assessed by blinded reviewers using the Physician's Global Assessment scale. [ Time Frame: Four weeks post final laser treatment. ]
- Subject satisfaction of laser treatment outcome at 4 weeks post-final treatment using a subject questionnaire. [ Time Frame: 4 weeks post-final treatment ]
- Subject satisfaction of the overall laser treatment procedure using a subject questionnaire. [ Time Frame: 4 weeks post-final treatment ]
Original Secondary Outcome: Same as current
Information By: Cutera Inc.
Dates:
Date Received: April 25, 2016
Date Started: April 2016
Date Completion: November 2016
Last Updated: May 4, 2016
Last Verified: April 2016
