Back to resultsA Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System
Primary Purpose
Underarm Hair
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
miraDry Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Underarm Hair focused on measuring Underarm Hair, Underarm Hair Reduction, Axillary Hair, Axillary Hair Reduction, Underarm Odor, Axillary Odor
Eligibility 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
Sites / Locations
- Zel Skin and Laser Specialists
- Laser & Skin Surgery Center of NY
- Lehigh Valley Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Group miraDry Treatment
Arm Description
This is a single group study where each enrolled subject will receive active miraDry treatment in each axilla.
Outcomes
Primary Outcome Measures
Patients with successful hair reduction
Percentage of patients that show a >=30% reduction in underarm hair at the 3 month visit compared to baseline.
Secondary Outcome Measures
Patients with successful hair reduction
Percentage of patients that achieve a >=30% reduction in underarm hair at the 12 month visit compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01732497
Brief Title
A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System
Official Title
A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Miramar Labs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Underarm Hair
Keywords
Underarm Hair, Underarm Hair Reduction, Axillary Hair, Axillary Hair Reduction, Underarm Odor, Axillary Odor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Group miraDry Treatment
Arm Type
Experimental
Arm Description
This is a single group study where each enrolled subject will receive active miraDry treatment in each axilla.
Intervention Type
Device
Intervention Name(s)
miraDry Treatment
Intervention Description
Application of electromagnetic energy to heat the lower dermis.
Primary Outcome Measure Information:
Title
Patients with successful hair reduction
Description
Percentage of patients that show a >=30% reduction in underarm hair at the 3 month visit compared to baseline.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patients with successful hair reduction
Description
Percentage of patients that achieve a >=30% reduction in underarm hair at the 12 month visit compared to baseline
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Patient satisfaction with hair reduction
Description
Patients will provide their evaluation of satisfaction with the hair reduction seen
Time Frame
All follow-up visits through 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy Quiroz, BS, RN
Organizational Affiliation
Miramar Labs, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Zel Skin and Laser Specialists
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55424
Country
United States
Facility Name
Laser & Skin Surgery Center of NY
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Lehigh Valley Dermatology
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System
We'll reach out to this number within 24 hrs