Clinical Trial: Pilot Study of a Novel IPL for Removal of Unwanted Fine Body Hair

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Controlled, Open-Label Pilot Study of a Novel IPL for Removal of Unwanted Fine Hair

Brief Summary:

The purpose of this randomized, controlled, open-label pilot study is to evaluate the safety and efficacy of a novel intense pulsed light (IPL) device for removal of unwanted fine body hair.

Subjects will have a designated treatment area on one forearm divided into four equal-size quadrants. One quadrant will serve as the un-treated control area and the other 3 quadrants will be treated with the Cutera Prowave LX IPL. Subjects will receive 3 IPL treatments, spaced 8 weeks apart, on the designated area and will be followed at 12-weeks post-final treatment.


Detailed Summary:
Sponsor: Cutera Inc.

Current Primary Outcome: Change from Baseline in Quantitative Hair Count at 12-weeks post-final treatment. [ Time Frame: 12-weeks post-final treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from Baseline in Quantitative Hair Count at 8-weeks and 16-weeks. [ Time Frame: 8 weeks and 16 weeks ]
  • Percent Hair Reduction at 12-weeks post-final treatment as compared to Baseline [ Time Frame: 12-weeks post-final treatment ]
  • Average Subject Satisfaction Score [ Time Frame: 12-weeks post-final treatment ]
    Subjects will be asked to complete a questionnaire about the subject's satisfaction with the treatment results.
  • Average Subject Discomfort during Treatment [ Time Frame: Day 0, 8 weeks and 16 weeks ]
    Subjects will be asked to rate the discomfort experienced during hair removal treatments using a 0 to 10 numeric scale.
  • Number of Participants with Adverse Device Effects [ Time Frame: 12-weeks post final treatment ]


Original Secondary Outcome: Same as current

Information By: Cutera Inc.

Dates:
Date Received: July 18, 2013
Date Started: December 2013
Date Completion:
Last Updated: September 9, 2015
Last Verified: September 2015