Ultrasound Device for Hair Removal

NCT01057134 | Completed Results

• 1 other identifier: C-09-UP01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hair Removal

Keywords

Hair Reduction Arm Leg; Unwanted hair

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Site treated with UHAIR

EXPERIMENTAL

The arm, calf, and thigh will be treated

Device: Cutera Ultrasound Device

Interventions

Cutera Ultrasound Device DEVICE

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

Also known as: UHAIR

Site treated with UHAIR

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cutera Inc.: lead

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-656-9612

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 27, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 25, 2023
• Results First Posted: September 25, 2023

Record last verified: 2023-09