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 ]

The primary efficacy endpoint is to measure the average percentage of hair reduction at 3 months post last treatment computed over all subjects and all treatment sites. Hair reduction will be evaluated by counting the number of terminal hairs present in the 3 cm by 3 cm defined region by at least two independent blinded trained reviewers of photos taken at baseline and at the follow-up visits.


Original Primary Outcome: The average percentage of hair reduction [ Time Frame: 3 months after last treatment ]

The primary efficacy endpoint is to measure the average percentage of hair reduction at 3 months post last treatment computed over all subjects and all treatment sites. Hair reduction will be evaluated by counting the number of terminal hairs present in the 3 cm by 3 cm defined region by at least two independent blinded trained reviewers of photos taken at baseline and at the follow-up visits.


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