Underarm HairNCT01732497
A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System
A study testing miraDry Treatment in people with Underarm Hair, run by Miramar Labs at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate hair reduction in the underarms in patients treated with the miraDry System. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Underarm Hair
- What is being tested?
- miraDry Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age
- Visible underarm hair (prefer light colored hair; blonde, red, gray)
Who cannot join
- Secondary Axillary Hyperhidrosis
- Prior surgery and/or Botox Injections in axillae
- Pacemaker or requires supplemental oxygen
- Pregnant
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lehigh Valley Dermatology
Bethlehem, Pennsylvania, 18017
Zel Skin and Laser Specialists
Edina, Minnesota, 55424
Laser & Skin Surgery Center of NY
New York, New York, 10016
About this study
The purpose of this study is to evaluate hair reduction in the underarms in patients treated with the miraDry System.
Read the detailed description
This study is designed to quantify the amount of hair reduction in patients treated with the miraDry System in the axilla. Hair counts will be assessed before and after treatments including at follow up visits.
- Conditions
- Underarm Hair
- Being tested
- miraDry Treatment
- Keywords
- Underarm Hair, Underarm Hair Reduction, Axillary Hair, Axillary Hair Reduction, Underarm Odor, Axillary Odor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miraDry TreatmentDevice
Application of electromagnetic energy to heat the lower dermis.
| Study group | Role | What they receive |
|---|---|---|
| Single Group miraDry Treatment | Experimental | This is a single group study where each enrolled subject will receive active miraDry treatment in each axilla. Receives: Device: miraDry Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with successful hair reduction
Percentage of patients that show a >=30% reduction in underarm hair at the 3 month visit compared to baseline.
Measured: 3 months
Secondary outcomes (1)
Patients with successful hair reduction
Percentage of patients that achieve a >=30% reduction in underarm hair at the 12 month visit compared to baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underarm HairStudies 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
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miramar Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy Quiroz, BS, RN, Study director, Miramar Labs, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732497
- Sponsor's protocol ID
- CP-0009
- Status last verified
- Mar 2016
- First submitted
- 19 Nov 2012
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System
- ClinicalTrials.gov ID
- NCT01732497
- Acronym / sponsor ID
- CP-0009
- Conditions
- Underarm Hair
- Keywords
- Underarm Hair, Underarm Hair Reduction, Axillary Hair, Axillary Hair Reduction, Underarm Odor, Axillary Odor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Miramar LabsIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Not posted in the source record
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 hair reduction in the underarms in patients treated with the miraDry System.
Detailed description
This study is designed to quantify the amount of hair reduction in patients treated with the miraDry System in the axilla. Hair counts will be assessed before and after treatments including at follow up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group miraDry Treatment | Experimental | Device: miraDry TreatmentThis is a single group study where each enrolled subject will receive active miraDry treatment in each axilla. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age
- Visible underarm hair (prefer light colored hair; blonde, red, gray)
Key exclusion criteria (4 listed)
- Secondary Axillary Hyperhidrosis
- Prior surgery and/or Botox Injections in axillae
- Pacemaker or requires supplemental oxygen
- Pregnant
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 |
|---|---|---|
| miraDry TreatmentApplication of electromagnetic energy to heat the lower dermis. | Device | Single Group miraDry Treatment |
Primary outcome
Patients with successful hair reduction
Time frame: 3 months
Percentage of patients that show a >=30% reduction in underarm hair at the 3 month visit compared to baseline.
1 secondary outcome
Patients with successful hair reduction
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Kathy Quiroz, BS, RN study director
Miramar Labs, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miraDry Treatment in people with Underarm Hair, run by Miramar Labs at 3 sites in United States.
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 2 inclusion and 4 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 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patients with successful hair reduction (time frame: 3 months). 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 1 Apr 2016.