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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01057134
Other study ID # C-09-UP01
Secondary ID C-09-UP01
Status Completed
Phase
First received
Last updated
Start date March 2010
Est. completion date May 2011

Study information

Verified date September 2023
Source Cutera Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cutera Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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