Comparison of Efficacy, Safety and Tolerability of Two Different 810 nm Diode Lasers for Hair Reduction
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Reduction in hair growth [ Time Frame: 12 months ] [ Designated as safety issue: No ]Photographic hair count at baseline, and at 1, 6, 12 months following last (5th laser treatment)
- Reduction in hair density [ Time Frame: 12 months ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]Skin biopsy of treatment area taken at 24 hr after the 1st and 5th treatment in two subjects receiving .with the Alma laser
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|