Comparison of Efficacy, Safety and Tolerability of Two Different 810 nm Diode Lasers for Hair Reduction
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|ClinicalTrials.gov Identifier: NCT01212172|
Recruitment Status : Completed
First Posted : September 30, 2010
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypertrichosis||Device: Soprano/SHR Device: LightSheer||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Study Start Date :||September 2010|
|Primary Completion Date :||September 2013|
|Study Completion Date :||September 2013|
Active Comparator: Soprano/SHR
Alma Soprano/SHR 810 nm Diode Laser
For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time.
Other Name: Soprano/SHR laser
Active Comparator: LightSheer
LightSheer Duet 810 nm diode laser
The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings.
Other Name: Duet LightSheer
- 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]
- 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).
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): NCT01212172
|United States, California|
|Department of Dermatology Clinical Research|
|Irvine, California, United States, 92697|
|Principal Investigator:||Christopher B Zachary, MBBS, FRCP||University of California, Irvine|