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OpenTrials
Completed

NCT Number: NCT01732497

A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System

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

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Key information

Conditions

Underarm Hair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zel Skin and Laser Specialists, Edina, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

miraDry Treatment

Device

Application of electromagnetic energy to heat the lower dermis.

Primary outcomes

  1. Patients with successful hair reduction

    Time frame: 3 months

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

Secondary outcomes

  1. Patients with successful hair reduction

    Time frame: 12 months

    Percentage of patients that achieve a >=30% reduction in underarm hair at the 12 month visit compared to baseline

Other outcomes

  1. Patient satisfaction with hair reduction

    Time frame: All follow-up visits through 12 months

    Patients will provide their evaluation of satisfaction with the hair reduction seen

Sponsors and collaborators

Lead sponsor

Miramar Labs

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 22, 2012
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.