Trial Outcomes & Findings for Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece (NCT NCT01282866)

NCT ID: NCT01282866

Last Updated: 2016-10-21

Results Overview

The hair at the treatment area is counted at Baseline and 6 months following the last treatment. Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: 6 month following last treatment
• Results posted on: 2016-10-21

Participant Flow

Participant milestones

Measure	HS Treatment Treatment with the LightSheer Duet laser HS handpiece: Treatment parameters: Fluence: 9-12J/cm\^2, pulse duration: 30 to 70ms,medium to low vacuum levels. All patients were treated in the Axilla area.
Overall Study STARTED	35
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	HS Treatment Treatment with the LightSheer Duet laser HS handpiece: Treatment parameters: Fluence: 9-12J/cm\^2, pulse duration: 30 to 70ms,medium to low vacuum levels. All patients were treated in the Axilla area.
Overall Study Adverse Event	1

Baseline Characteristics

Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece

Baseline characteristics by cohort

Measure	HS Treatment n=35 Participants Treatment with the LightSheer Duet laser HS handpiece: Treatment parameters: Fluence: 9-12J/cm\^2, pulse duration: 30 to 70ms,medium to low vacuum levels. All patients were treated in the Axilla area.
Age, Continuous	30.9 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 month following last treatment

The hair at the treatment area is counted at Baseline and 6 months following the last treatment.

Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline.

Outcome measures

Measure	HS Treatment n=34 Participants Treatment with the LightSheer Duet laser HS handpiece: Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels. All patients were treated in the Axilla area.
Hair Count	54 percentage of hair clearance Standard Deviation 24

SECONDARY outcome

Timeframe: Each treatment

The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants.

Outcome measures

Measure	HS Treatment n=34 Participants Treatment with the LightSheer Duet laser HS handpiece: Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels. All patients were treated in the Axilla area.
Treatment Time	3.5 minutes Standard Deviation 2.7

SECONDARY outcome

Timeframe: Each treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 month following last treatment

Population: The number of participants who completed 15 months follow up was 23 out of 35.

The hair at the treatment area is counted at Baseline and 15 months following the last treatment.

Hair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline.

Outcome measures

Measure	HS Treatment n=23 Participants Treatment with the LightSheer Duet laser HS handpiece: Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels. All patients were treated in the Axilla area.
Hair Count	42 percentage of hair clearance Standard Deviation 25

Adverse Events

HS Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	HS Treatment n=35 participants at risk Treatment with the LightSheer Duet laser HS handpiece: Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels. All patients were treated in the Axilla area.
Musculoskeletal and connective tissue disorders injured ankle	2.9% 1/35

Other adverse events

Adverse event data not reported

Additional Information

Suzanne Kilmer, MD

Laser & Skin Surgery Medical Group Inc.

Phone: 916-456-0400

Email: Study@skinlasers.com

Results disclosure agreements

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