An interventional study of Cutera Ultrasound Device in Hair Removal, sponsored by Cutera Inc.. Completed. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by Cutera Inc. · Interventional and Treatment
The purpose of this study is to evaluate the safety and efficacy of the Cutera UHAIR ultrasound device for hair removal.
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.
Cutera Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 19 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The arm, calf, and thigh will be treated
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.
Also known as: UHAIR
Reduction in Hair Count in the Treated Area
Percent hair reduction 3 months post final treatment compared to baseline in the treated areas
Time frame: baseline and 3 months post final treatment (up to 28 weeks)
| Milestone | All Study Participants |
|---|---|
| Started | 10 |
| Completed | 9 |
| Not completed | 1 |
Percent hair reduction 3 months post final treatment compared to baseline in the treated areas
| percentage of hair reduction | Arms | Calf | Thigh |
|---|---|---|---|
| Reduction in Hair Count in the Treated Area | 13.1 ± 9.1 | 10.7 ± 9.9 | 18.7 ± 15.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Study Participants | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Event | All Study Participants |
|---|---|
| BlisteringSkin and subcutaneous tissue disorders | 2/10 |
| DiscomfortSkin and subcutaneous tissue disorders | 1/10 |
| ErythemaSkin and subcutaneous tissue disorders | 1/10 |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 7 |
| Male | 3 |
No study locations are listed for this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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