Ultrasound Device for Hair Removal

Cutera UHAIR for Hair Removal

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

Study Overview

• Status: Completed
• Conditions: Hair Removal
• Intervention / Treatment: Device: Cutera Ultrasound Device

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 Type: Interventional
• Enrollment (Actual): 10

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Site treated with UHAIR; The arm, calf, and thigh will be treated	Device: Cutera 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.; Other Names: UHAIR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Hair Count in the Treated Area	Percent hair reduction 3 months post final treatment compared to baseline in the treated areas	baseline and 3 months post final treatment (up to 28 weeks)

Collaborators and Investigators

• Sponsor: Cutera Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 25, 2010
• First Submitted That Met QC Criteria: January 26, 2010
• First Posted (Estimated): January 27, 2010

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Hair Reduction Arm Leg; Unwanted hair
• Other Study ID Numbers: C-09-UP01 (Other Identifier: Cutera Inc.)