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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
Sponsor:
Information provided by (Responsible Party):
Christopher Zachary, University of California, Irvine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertrichosis
Interventions Device: Soprano/SHR
Device: LightSheer
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Soprano Duet 810 nm Diode Laser LightSheer Duet 810 nm Diode Laser
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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.

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.

Period Title: Overall Study
Started 10 10
Completed 9 9
Not Completed 1 1
Arm/Group Title Side-by Side Comparsion of Soprano/SHR to Light Sheer
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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.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Change in Hair Growth
Hide Description % reduction from baseline hair count at time points 1 month, 6 months and 12 months [following last (5th laser) treatment]
Time Frame 1 month, 6 month, 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Soprano/SHR LightSheer
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: % hair reduction
1 month 57.6  (34.03) 52.1  (32.2)
6 month 39.3  (23.3) 29.9  (21.7)
12 month 47.5  (38.41) 44.7  (43.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Soprano/SHR, LightSheer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2879
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.9
Confidence Interval (2-Sided) 95%
-6.7 to 21.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Pain Rating Scale
Hide Description Pain during each treatment was measured subjectively by patients on a 0–10 visual analogue scale (0=no pain, 10=unbearable pain).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LightSheer Soprano/SHR
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 20 20
Median (95% Confidence Interval)
Unit of Measure: Units on a Scale
3.6
(2.8 to 4.5)
2.7
(1.8 to 3.5)
Time Frame At each laser treatment visit and all post-laser treatment follow-up visits (1 month, 6 months, 12 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Soprano/SHR 810 nm Diode Laser Light Sheer 810 nm Diode Laser
Hide Arm/Group Description

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

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.

All-Cause Mortality
Soprano/SHR 810 nm Diode Laser Light Sheer 810 nm Diode Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Soprano/SHR 810 nm Diode Laser Light Sheer 810 nm Diode Laser
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Soprano/SHR 810 nm Diode Laser Light Sheer 810 nm Diode Laser
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/20 (30.00%)      5/20 (25.00%)    
General disorders     
Burn   6/20 (30.00%)  8 5/20 (25.00%)  9
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Christopher B. Zachary
Organization: UC Irvine Dermatology Research Center
Phone: 949 824 7103
Responsible Party: Christopher Zachary, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01212172     History of Changes
Other Study ID Numbers: 2010-7704
First Submitted: September 22, 2010
First Posted: September 30, 2010
Results First Submitted: December 4, 2014
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016