Ultrasound Device for Hair Removal

Cutera Inc.10 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of the Cutera UHAIR ultrasound device for hair removal.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hair Removal

Interventions

Cutera Ultrasound DeviceDEVICE

Pulse duration 10-100 ms, fluence greater or equal to 50 J/cm2, contact tip temperature 5-30 celsus, frequency 5-20 MHz.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

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