Underarm Hair
Conditions
Keywords
Underarm Hair, Underarm Hair Reduction, Axillary Hair, Axillary Hair Reduction, Underarm Odor, Axillary Odor
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.
Interventions
DEVICEmiraDry Treatment
Application of electromagnetic energy to heat the lower dermis.
Sponsors
Miramar Labs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with hair reduction | All follow-up visits through 12 months | Patients will provide their evaluation of satisfaction with the hair reduction seen |
Countries
United States
Outcome results
None listed