Axillary Hair Reduction Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Miramar Labs
ClinicalTrials.gov Identifier:
NCT01732497
First received: November 19, 2012
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Axillary Hair
Device: miraDry Treatment

Study Type: Interventional
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

Further study details as provided by Miramar Labs:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 55
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732497

Locations
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
Sponsors and Collaborators
Miramar Labs
Investigators
Principal Investigator: Roy Geronemus, MD Laser and Skin Surgery Center of NY
  More Information

No publications provided

Responsible Party: Miramar Labs
ClinicalTrials.gov Identifier: NCT01732497     History of Changes
Other Study ID Numbers: CP-0009
Study First Received: November 19, 2012
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Miramar Labs:
Underarm Hair
Underarm Hair Reduction
Axillary Hair
Axillary Hair Reduction
Underarm Odor
Axillary Odor

ClinicalTrials.gov processed this record on October 23, 2014