Clinical Trial: Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: LASER HAIR REDUCTION BY COMBINED BIPOLAR RF AND 755 nm LASER ENERGIES
Brief Summary: The objective of this post marketing study is to further explore a variety of treatment parameters in order to optimize the optical (laser) and electrical (RF) treatments over the various skin types, when using a combination 755 nm alexandrite laser together with a bipolar RF energy system, for the purpose of hair reduction.
Detailed Summary: The study device (Helos) combines 755nm alexandrite laser energy with bipolar RF energy. The laser can deliver 0.25 to 100 ms laser pulses at a maximum of 20 J/cm2. Bipolar RF energy will be delivered across the laser beam via two appropriately sized electrodes and spacing between the electrodes. Bipolar RF energy may be delivered at a maximum of 35 J operating at 1 MHz. Typical RF pulses will be of duration of between 100 and 300ms. Epidermal cooling is accomplished via contact with a cooled window.
Sponsor: Syneron Medical
Current Primary Outcome: Average percentage of hair reduction by hair counts at baseline compared to 3 months after last treatment [ Time Frame: Baseline, 3 months after last treatment ]
Original Primary Outcome: The average percentage of hair reduction [ Time Frame: 3 months after last treatment ]
Current Secondary Outcome: Average hair reduction for each anatomical site [ Time Frame: 6-12 months after last treatment ]
Original Secondary Outcome: Same as current
Information By: Syneron Medical
Dates:
Date Received: May 28, 2014
Date Started: May 2014
Date Completion: January 2017
Last Updated: May 23, 2016
Last Verified: May 2016