Hair RemovalNCT01057134
Ultrasound Device for Hair Removal
A study testing Cutera Ultrasound Device in people with Hair Removal, run by Cutera Inc..
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the Cutera UHAIR ultrasound device for hair removal. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Removal
- What is being tested?
- Cutera Ultrasound Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
Official title: Cutera UHAIR for Hair Removal
The purpose of this study is to evaluate the safety and efficacy of the Cutera UHAIR ultrasound device for hair removal.
Read the detailed 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.
- Conditions
- Hair Removal
- Being tested
- Cutera Ultrasound Device
- Keywords
- Hair Reduction Arm Leg, Unwanted hair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutera Ultrasound DeviceDevice
Also called UHAIR
Pulse duration 10-100 ms, fluence greater or equal to 50 J/cm2, contact tip temperature 5-30 celsus, frequency 5-20 MHz.
| Study group | Role | What they receive |
|---|---|---|
| Site treated with UHAIR | Experimental | The arm, calf, and thigh will be treated Receives: Device: Cutera Ultrasound Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Hair Count in the Treated Area
Percent hair reduction 3 months post final treatment compared to baseline in the treated areas
Measured: baseline and 3 months post final treatment (up to 28 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hair RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057134
- Sponsor's protocol ID
- C-09-UP01
- Other IDs
- C-09-UP01
- Status last verified
- Sep 2023
- First submitted
- 25 Jan 2010
- Last updated
- 25 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutera UHAIR for Hair Removal
- ClinicalTrials.gov ID
- NCT01057134
- Acronym / sponsor ID
- C-09-UP01
- Conditions
- Hair Removal
- Keywords
- Hair Reduction Arm Leg, Unwanted hair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Posted 25 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of the Cutera UHAIR ultrasound device for hair removal.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Site treated with UHAIR | Experimental | Device: Cutera Ultrasound DeviceThe arm, calf, and thigh will be treated |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cutera Ultrasound DeviceAlso: UHAIRPulse duration 10-100 ms, fluence greater or equal to 50 J/cm2, contact tip temperature 5-30 celsus, frequency 5-20 MHz. | Device | Site treated with UHAIR |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cutera Ultrasound Device in people with Hair Removal, run by Cutera Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Hair Count in the Treated Area (time frame: baseline and 3 months post final treatment (up to 28 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.