Clinical Trial: Comparison of Efficacy, Safety and Tolerability of Two Different 810 nm Diode Lasers for Hair Reduction

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

Official Title: Side-by-Side Comparison of 810 nm Diode Laser Technology With Low Fluence-High Repetition Rate vs Low Fluence-Vacuum Assist - A Split - Extremity Efficacy , Safety and Tolerability Study

Brief Summary: The purpose of this research study is to compare two different 810 diode laser systems (Soprano XL (SHR Mode)and Light Sheer Duet) for laser hair removal. The goal is to determine if each laser system is effective at reducing the amount of hair on the lower legs or the axilla (arm pit). Another goal is determine the subject's perspective on the treatment including tolerability and effectiveness.

Detailed Summary:

This side-by-side split body, blinded, randomized single-center study is comparing two different 810 nm diode laser technologies for the purpose of permanent hair reduction to determine the effectiveness and subject's tolerance for hair reduction. Twenty volunteers will be enrolled into this study. Subjects will receive a total of 5 treatments of either axilla or lower legs. 10 patients will have both axilla treated while the other 10 subjects will have the lower legs treated. Placement to the axilla treatment group vs. the lower leg treatment group is random.

Treatment areas will be randomized to receive Soprano SHR treatment or Light Sheer/Duet treatment. One extremity (example: right axilla) will receive Soprano SHR treatment and the contra-lateral extremity (example: left axilla) will receive Duet treatment. The treatments will occur every 6 - 8 weeks and then there will be follow up visits at 1 month, 6 months, and 12 months after the last treatment.


Sponsor: University of California, Irvine

Current Primary Outcome: Change in Hair Growth [ Time Frame: 1 month, 6 month, 12 month ]

% reduction from baseline hair count at time points 1 month, 6 months and 12 months [following last (5th laser) treatment]


Original Primary Outcome: Reduction in hair growth [ Time Frame: 12 months ]

Photographic hair count at baseline, and at 1, 6, 12 months following last (5th laser treatment)


Current Secondary Outcome: Pain Rating Scale [ Time Frame: 12 months ]

Pain during each treatment was measured subjectively by patients on a 0-10 visual analogue scale (0=no pain, 10=unbearable pain).


Original Secondary Outcome:

  • Reduction in hair density [ Time Frame: 12 months ]
    Photographic imaging of hair density at 1, 6, 12 months following last (5th) laser treatment.
  • Hair follicle histology [ Time Frame: Skin biopsy of treatment area taken at 24 hr after the. 1st and 5th treatment. ]
    Skin biopsy of treatment area taken at 24 hr after the 1st and 5th treatment in two subjects receiving .with the Alma laser


Information By: University of California, Irvine

Dates:
Date Received: September 22, 2010
Date Started: September 2010
Date Completion:
Last Updated: January 7, 2016
Last Verified: October 2015