Trial Outcomes & Findings for Comparison of Efficacy, Safety and Tolerability of Two Different 810 nm Diode Lasers for Hair Reduction (NCT NCT01212172)

NCT ID: NCT01212172

Last Updated: 2016-02-05

Results Overview

% reduction from baseline hair count at time points 1 month, 6 months and 12 months \[following last (5th laser) treatment\]

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 20 participants
• Primary outcome timeframe: 1 month, 6 month, 12 month
• Results posted on: 2016-02-05

Participant Flow

Participant milestones

Measure	Soprano Duet 810 nm Diode Laser Soprano Duet 810 nm diode laser Soprano/SHR: 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.	LightSheer Duet 810 nm Diode Laser Soprano and LightSheer Duet 810 nm diode laser LightSheer: 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.
Overall Study STARTED	10	10
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Efficacy, Safety and Tolerability of Two Different 810 nm Diode Lasers for Hair Reduction

Baseline characteristics by cohort

Measure	Side-by Side Comparsion of Soprano/SHR to Light Sheer n=20 Participants Alma Soprano/SHR 810 nm Diode Laser Soprano/SHR: 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. LightSheer Duet 810 nm diode laser LightSheer: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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]

Outcome measures

Measure	Soprano/SHR n=20 Participants Alma Soprano/SHR 810 nm Diode Laser Soprano/SHR: 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.	LightSheer n=20 Participants LightSheer Duet 810 nm diode laser LightSheer: 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.
Change in Hair Growth 1 month	57.6 % hair reduction Standard Deviation 34.03	52.1 % hair reduction Standard Deviation 32.2
Change in Hair Growth 6 month	39.3 % hair reduction Standard Deviation 23.3	29.9 % hair reduction Standard Deviation 21.7
Change in Hair Growth 12 month	47.5 % hair reduction Standard Deviation 38.41	44.7 % hair reduction Standard Deviation 43.2

SECONDARY outcome

Timeframe: 12 months

Pain during each treatment was measured subjectively by patients on a 0-10 visual analogue scale (0=no pain, 10=unbearable pain).

Outcome measures

Measure	Soprano/SHR n=20 Participants Alma Soprano/SHR 810 nm Diode Laser Soprano/SHR: 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.	LightSheer n=20 Participants LightSheer Duet 810 nm diode laser LightSheer: 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.
Pain Rating Scale	3.6 Units on a Scale Interval 2.8 to 4.5	2.7 Units on a Scale Interval 1.8 to 3.5

Adverse Events

Soprano/SHR 810 nm Diode Laser

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Light Sheer 810 nm Diode Laser

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Soprano/SHR 810 nm Diode Laser n=20 participants at risk Alma Soprano/SHR VS Light Sheer Duet 810 nm Diode Lasers Right Axilla or Lower Leg Soprano/SHR: 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.	Light Sheer 810 nm Diode Laser n=20 participants at risk Light Sheer 810 nm Diode Laser Left Axilla or Lower Leg LightSheer: 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.
General disorders Burn	30.0% 6/20 • Number of events 8 • At each laser treatment visit and all post-laser treatment follow-up visits (1 month, 6 months, 12 months)	25.0% 5/20 • Number of events 9 • At each laser treatment visit and all post-laser treatment follow-up visits (1 month, 6 months, 12 months)

Additional Information

Christopher B. Zachary

UC Irvine Dermatology Research Center

Phone: 949 824 7103

Email: czachary@uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place