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A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01732497
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Miramar Labs

Study Description
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Brief Summary:
The purpose of this study is to evaluate hair reduction in the underarms in patients treated with the miraDry System.

Condition or disease Intervention/treatment Phase
Underarm Hair Device: miraDry Treatment Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System
Study Start Date : September 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Group miraDry Treatment
This is a single group study where each enrolled subject will receive active miraDry treatment in each axilla.
 Device: miraDry Treatment
Application of electromagnetic energy to heat the lower dermis.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patients with successful hair reduction [ Time Frame: 12 months ]
    Percentage of patients that achieve a >=30% reduction in underarm hair at the 12 month visit compared to baseline


Other Outcome Measures:
  1. Patient satisfaction with hair reduction [ Time Frame: All follow-up visits through 12 months ]
    Patients will provide their evaluation of satisfaction with the hair reduction seen


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age
  • Visible underarm hair (prefer light colored hair; blonde, red, gray)

Exclusion Criteria:

  • Secondary Axillary Hyperhidrosis
  • Prior surgery and/or Botox Injections in axillae
  • Pacemaker or requires supplemental oxygen
  • Pregnant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732497


Locations
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United States, Minnesota
Zel Skin and Laser Specialists
Edina, Minnesota, United States, 55424
United States, New York
Laser & Skin Surgery Center of NY
New York, New York, United States, 10016
United States, Pennsylvania
Lehigh Valley Dermatology
Bethlehem, Pennsylvania, United States, 18017
Sponsors and Collaborators
Miramar Labs
Investigators
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Study Director: Kathy Quiroz, BS, RN Miramar Labs, Inc
More Information
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Responsible Party: Miramar Labs
ClinicalTrials.gov Identifier: NCT01732497    
Other Study ID Numbers: CP-0009
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Miramar Labs:
Underarm Hair
Underarm Hair Reduction
Axillary Hair
 Axillary Hair Reduction
Underarm Odor
Axillary Odor
Additional relevant MeSH terms:
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Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical