N/A
N=10
Ultrasound Device for Hair Removal
Hair Removal
Bottom Line
View on ClinicalTrials.gov: NCT01057134 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Reduction in Hair Count in the Treated Area — 13.1; 10.7; 18.7 percentage of hair reduction
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cutera Ultrasound Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cutera Inc.
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Hair Count in the Treated Area |
13.1; 10.7; 18.7 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of the Cutera UHAIR ultrasound device for hair removal.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01057134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.