Ultrasound Device for Hair Removal

Completed

• Conditions: Hair Removal
• Interventions: Device: Cutera Ultrasound Device

• Registration Number: NCT01057134
• Lead Sponsor: Cutera Inc.

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.

Study Timeline

• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Study Start: 2010-03
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Results First Submitted: 2023-08-28
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Results First Posted: 2023-09-25
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Site treated with UHAIR	Cutera Ultrasound Device	The arm, calf, and thigh will be treated

Primary Outcome Measures

Name	Time	Method
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