Axillary Hair Reduction Study
The purpose of this study is to evaluate hair reduction in the underarms in patients treated with the miraDry System.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System|
- Patients with successful hair reduction [ Time Frame: 3 months ] [ Designated as safety issue: No ]Percentage of patients that show a >=30% reduction in underarm hair at the 3 month visit compared to baseline.
- Patients with successful hair reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]Percentage of patients that achieve a >=30% reduction in underarm hair at the 12 month visit compared to baseline
- Patient satisfaction with hair reduction [ Time Frame: All follow-up visits through 12 months ] [ Designated as safety issue: No ]Patients will provide their evaluation of satisfaction with the hair reduction seen
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732497
|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|
|Principal Investigator:||Roy Geronemus, MD||Laser and Skin Surgery Center of NY|