Ultrasound Device for Hair Removal

NCT ID: NCT01057134

Last Updated: 2023-09-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hair Removal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Site treated with UHAIR

The arm, calf, and thigh will be treated

Group Type EXPERIMENTAL

Cutera Ultrasound Device

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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UHAIR

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cutera Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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C-09-UP01

Identifier Type: OTHER

Identifier Source: secondary_id

C-09-UP01

Identifier Type: -

Identifier Source: org_study_id

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