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

NCT ID: NCT01732497

Last Updated: 2016-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Underarm Hair

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single Group miraDry Treatment

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

Group Type EXPERIMENTAL

miraDry Treatment

Intervention Type DEVICE

Application of electromagnetic energy to heat the lower dermis.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

miraDry Treatment

Application of electromagnetic energy to heat the lower dermis.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Miramar Labs

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kathy Quiroz, BS, RN

Role: STUDY_DIRECTOR

Miramar Labs, Inc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zel Skin and Laser Specialists

Edina, Minnesota, United States

Site Status

Laser & Skin Surgery Center of NY

New York, New York, United States

Site Status

Lehigh Valley Dermatology

Bethlehem, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CP-0009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Minoxidil 1% for Eyebrow Enhancement
NCT01924000 COMPLETED PHASE4
Minoxidil 2% for Eyebrow Enhancement
NCT01672307 COMPLETED PHASE4