New York, New York 10016

  • Underarm Hair

Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

CP-0009


NCT ID:

NCT01732497


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Miramar Labs


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

56


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kathy Quiroz, BS, RN
Study Director
Miramar Labs, Inc

Study Dates

Start Date:September 2012
Completion Date:November 2014
Completion Type:Actual
Primary Completion Date:November 2014
Primary Completion Type:Actual
Verification Date:March 2016
Last Changed Date:March 30, 2016
First Received Date:November 19, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Patients with successful hair reduction
Time Frame:3 months
Safety Issues:False
Description:Percentage of patients that show a >=30% reduction in underarm hair at the 3 month visit compared to baseline.
Outcome Type:Secondary Outcome
Measure:Patients with successful hair reduction
Time Frame:12 months
Safety Issues:False
Description:Percentage of patients that achieve a >=30% reduction in underarm hair at the 12 month visit compared to baseline

Study Interventions

Intervention Type:Device
Name:miraDry Treatment
Description:Application of electromagnetic energy to heat the lower dermis.
Arm Name:Single Group miraDry Treatment

Study Arms

Study Arm Type:Experimental
Arm Name:Single Group miraDry Treatment
Description:This is a single group study where each enrolled subject will receive active miraDry treatment in each axilla.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Miramar Labs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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