Ultrasound Device for Hair Removal

Hair Removal Clinical Trial

Official title:

Cutera UHAIR for Hair Removal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057134
• Other study ID #: C-09-UP01
• Secondary ID: C-09-UP01
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hair Removal

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)