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OpenTrials
Completed

NCT Number: NCT01057134

Ultrasound Device for Hair Removal

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

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: UHAIR

Primary outcomes

  1. Reduction in Hair Count in the Treated Area

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cutera Inc.

Industry

Registry information

Official study title

Cutera UHAIR for Hair Removal

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2010
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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