Hair Removal
Conditions
Keywords
Hair Reduction Arm Leg, Unwanted hair
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the Cutera UHAIR ultrasound device for hair removal.
Detailed description
The purpose of this study is to evaluate the Cutera UHAIR device for safety and efficacy for removal and long term reduction of unwanted hair on subjects with Fitzpatrick skin types I-IV and dark (black or brown), red, and blonde colored hair. At investigator's discretion, each subject will receive treatments and will be scheduled for follow-up visits after the final treatment. The treated area(s) will be photographed at each visit for analysis.
Interventions
DEVICECutera Ultrasound Device
Pulse duration 10-100 ms, fluence greater or equal to 50 J/cm2, contact tip temperature 5-30 celsus, frequency 5-20 MHz.
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female at least 18 years of age * Fitxpatrick skin type I-IV * Area with unwanted hair * Subject must be able to read, understand and sign the consent form * Subject must adhere to the follow-up schedule and study instruction
Exclusion criteria
* Simultaneous participation in any other clinical study * Inability or unwillingness to follow the treatment schedule * Inability or unwillingness to sign the informed consent * Infection in the target area * Any disease or condition that could impair wound healing * History of keloid formation * History of malignant tumors in the target area * Skin abnormalities in the target area, e.g. cuts, scrapes, wounds, scars, large moles * History of hair removal in target area (light based or electrolysis) * Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Hair Count in the Treated Area | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Reduction in Hair Count in the Treated Area
Percent hair reduction 3 months post final treatment compared to baseline in the treated areas
Time frame: baseline and 3 months post final treatment (up to 28 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arms | Reduction in Hair Count in the Treated Area | 13.1 percentage of hair reduction | Standard Deviation 9.1 |
| Calf | Reduction in Hair Count in the Treated Area | 10.7 percentage of hair reduction | Standard Deviation 9.9 |
| Thigh | Reduction in Hair Count in the Treated Area | 18.7 percentage of hair reduction | Standard Deviation 15.5 |