Hair Removal Clinical Trial
Official title:
Cutera UHAIR for Hair Removal
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 |
Verified date | September 2023 |
Source | Cutera Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of the Cutera UHAIR ultrasound device for hair removal.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cutera Inc. |
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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