Trial Outcomes & Findings for Ultrasound Device for Hair Removal (NCT NCT01057134)

Results Overview

Percent hair reduction 3 months post final treatment compared to baseline in the treated areas

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

baseline and 3 months post final treatment (up to 28 weeks)

Results posted on

2023-09-25

Participant milestones
Measure	All Study Participants Subjects were treated on the calf, thigh, and arm with the Cutera UHAIR device.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Withdrawal data not reported

Ultrasound Device for Hair Removal

Baseline characteristics by cohort
Measure	All Study Participants n=10 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

Timeframe: baseline and 3 months post final treatment (up to 28 weeks)

Percent hair reduction 3 months post final treatment compared to baseline in the treated areas

Outcome measures
Measure	Arms n=9 Participants	Calf n=9 Participants	Thigh n=9 Participants
Reduction in Hair Count in the Treated Area	13.1 percentage of hair reduction Standard Deviation 9.1	10.7 percentage of hair reduction Standard Deviation 9.9	18.7 percentage of hair reduction Standard Deviation 15.5

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	All Study Participants n=10 participants at risk Subjects were treated on the calf, thigh, and arm with the Cutera UHAIR device.
Skin and subcutaneous tissue disorders Blistering	20.0% 2/10
Skin and subcutaneous tissue disorders Discomfort	10.0% 1/10
Skin and subcutaneous tissue disorders Erythema	10.0% 1/10

Cutera

Phone: 415-656-9612