Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction
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|ClinicalTrials.gov Identifier: NCT02465788|
Recruitment Status : Unknown
Verified May 2016 by Syneron Medical.
Recruitment status was: Active, not recruiting
First Posted : June 8, 2015
Last Update Posted : May 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Excess Hair Growth||Device: GentleTouch||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LASER HAIR REDUCTION BY COMBINED BIPOLAR RF AND 755 nm LASER ENERGIES|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||January 2017|
Experimental: 755nm alexandrite laser with bipolar RF
GentleTouch (Helos) combines 755nm alexandrite laser energy with bipolar RF energy.
Four distinct areas on each selected anatomical area will be treated with different treatment parameters.
- 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.
- Average hair reduction for each anatomical site [ Time Frame: 6-12 months after last treatment ]
- Side Effects and Adverse Events [ Time Frame: one year ]Safety will be evaluated based on the incidence and severity of adverse events caused by the laser treatments
- Histologic analysis of H&E stained tissue sections from biopsies [ Time Frame: day 1 ]Post-treatment biopsies may be taken at any time between the first treatment visit and the second treatment visit, prior to treatment.
- Numerical Response Scale for Rating Pain (NRS) [ Time Frame: every 4-6 weeks up to 24 weeks ]To evaluate subject's assessment of comfort associated with treatments. Treatment related pain will be assessed immediately after treatment, the subject will be asked to define how much pain they felt from treatment by choosing a number from 0 to 10.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465788
|United States, Illinois|
|Physicians Laser & Dermatology Institute, LLC|
|Chicago, Illinois, United States, 60611|
|Study Director:||Shlomit Mann||Syneron Medical Ltd.|