A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System
Not Applicable
Completed
- Conditions
- Underarm Hair
- Interventions
- Device: miraDry Treatment
- Registration Number
- NCT01732497
- Lead Sponsor
- Miramar Labs
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Group miraDry Treatment miraDry Treatment This is a single group study where each enrolled subject will receive active miraDry treatment in each axilla.
- Primary Outcome Measures
Name Time Method Patients with successful hair reduction 3 months Percentage of patients that show a \>=30% reduction in underarm hair at the 3 month visit compared to baseline.
- Secondary Outcome Measures
Name Time Method Patients with successful hair reduction 12 months Percentage of patients that achieve a \>=30% reduction in underarm hair at the 12 month visit compared to baseline
Trial Locations
- Locations (3)
Laser & Skin Surgery Center of NY
🇺🇸New York, New York, United States
Zel Skin and Laser Specialists
🇺🇸Edina, Minnesota, United States
Lehigh Valley Dermatology
🇺🇸Bethlehem, Pennsylvania, United States