NCT01732497

Brief Summary

The purpose of this study is to evaluate hair reduction in the underarms in patients treated with the miraDry System.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

November 19, 2012

Last Update Submit

March 30, 2016

Conditions

Underarm Hair

Keywords

Underarm HairUnderarm Hair ReductionAxillary HairAxillary Hair ReductionUnderarm OdorAxillary Odor

Outcome Measures

Primary Outcomes (1)

  • Patients with successful hair reduction

    Percentage of patients that show a \>=30% reduction in underarm hair at the 3 month visit compared to baseline.

    3 months

Secondary Outcomes (1)

  • Patients with successful hair reduction

    12 months

Other Outcomes (1)

  • Patient satisfaction with hair reduction

    All follow-up visits through 12 months

Study Arms (1)

Single Group miraDry Treatment

EXPERIMENTAL

This is a single group study where each enrolled subject will receive active miraDry treatment in each axilla.

Device: miraDry Treatment

Interventions

miraDry TreatmentDEVICE

Application of electromagnetic energy to heat the lower dermis.

Single Group miraDry Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Visible underarm hair (prefer light colored hair; blonde, red, gray)

You may not qualify if:

  • Secondary Axillary Hyperhidrosis
  • Prior surgery and/or Botox Injections in axillae
  • Pacemaker or requires supplemental oxygen
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Zel Skin and Laser Specialists

Edina, Minnesota, 55424, United States

Location

Laser & Skin Surgery Center of NY

New York, New York, 10016, United States

Location

Lehigh Valley Dermatology

Bethlehem, Pennsylvania, 18017, United States

Location

Study Officials

  • Kathy Quiroz, BS, RN

    Miramar Labs, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 22, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 1, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)