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OpenTrials
Completed

NCT Number: NCT01811004

Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis

The Purpose of the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary Hyperhidrosis.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sasaki Advanced Aesthetic Medical Center

Pasadena, California, 91105, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A healthy non-smoking male or female between 18-70 years of age
  • Understand/accept obligation not to receive any other procedures in anatomical areas exhibiting axillary hyperhidrosis through 3 months prior to treatment
  • Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits
  • Clinically diagnosed for primary hyperhidrosis of the axilla.
  • A self-assessed Hyperhidrosis Disease Severity Scale (HDSS) score of three (3) or four (4) a. Gravimetric >50mg/5min in each axilla

Exclusion criteria

  • Clinical diagnosis of secondary hyperhidrosis
  • Uncontrolled systemic disease or infection
  • Concurrent use of any hyperhidrosis treatments other than over the counter antiperspirants or deodorants
  • Receipt of Botox® or Dysport® within the past six months
  • Patients who refuse to stop using over the counter antiperspirants 24 hours prior to the day of surgery and each of the follow-up visits at 3 months and 6 months that Minors starch iodine tests may be performed.
  • Patients using or having used within 7 days of baseline visit: cholinomimetic agents, anticholinergic agents, prescription antiperspirants, any herbal medicine treatments or any other treatments for hyperhidrosis except OTC antiperspirant or planning to use such agents during the course of the study.
  • Any previous liposuction/liposculpture or any type of surgery for hyperhidrosis; OR any other types of treatments for hyperhidrosis in the area to be treated in the past 6 months
  • Has any other medical condition, that, in the investigator's opinion would interfere with the subject's participation in the study
  • Is susceptible to light induced seizures or history of seizures
  • Has a history of keloid formation
  • Significant cardiovascular disease
  • Bleeding disorders
  • Anti-platelet and anticoagulant medication
  • Sensitivity to lidocaine or epinephrine
  • Pregnancy or planned pregnancy
  • Existing neuromuscular disorders (myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis)
  • Electronic implants
  • Subjects requiring supplemental oxygen
  • Has therapies or medications which may interfere with the treatment (including medications causing photosensitivity
  • Allergic to Keflex

Treatment and study plan

miraDry

Device

miraDry

Nd:Yag Laser

Device

Nd:YAG 1440 nm Laser

Botox®

Device

Botox®

Primary outcomes

  1. Change in Sweating Assessed Using Gravimetry

    Time frame: 1 month follow up

    A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced.

  2. Change in Sweating Assessed Using Gravimetry

    Time frame: 3 month follow up

    A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced.

  3. Change in Sweating Assessed Using Gravimetry

    Time frame: 6 month follow up

    A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced.

  4. Change in Sweating Assessed Using Gravimetry

    Time frame: 9 month follow up

    A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced.

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 14, 2013
Registry last updated
Jan 22, 2021

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.

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