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

March 30, 2016 updated by: Miramar Labs
The purpose of this study is to evaluate hair reduction in the underarms in patients treated with the miraDry System.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Edina, Minnesota, United States, 55424
        • Zel Skin and Laser Specialists
    • New York
      • New York, New York, United States, 10016
        • Laser & Skin Surgery Center of NY
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Lehigh Valley Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
All follow-up visits through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miramar Labs

Investigators

  • Study Director: Kathy Quiroz, BS, RN, Miramar Labs, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 19, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (Estimate)

November 22, 2012

Study Record Updates

Last Update Posted (Estimate)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-0009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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