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

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ClinicalTrials.gov Identifier: NCT01811004
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Device: miraDry Device: Nd:YAG Laser Device: Botox® Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Botox®
Botox®
Device: Nd:YAG Laser
Nd:YAG 1440 nm Laser

Device: Botox®
Botox®

Experimental: miraDry®
miraDry®
Device: miraDry
miraDry

Device: Nd:YAG Laser
Nd:YAG 1440 nm Laser

Experimental: Nd: YAG laser
Nd: YAG laser 1440nm
Device: miraDry
miraDry

Device: Nd:YAG Laser
Nd:YAG 1440 nm Laser

Device: Botox®
Botox®




Primary Outcome Measures :
  1. Comparison of Amount of Sweat Produced [ Time Frame: up to 12 months post treatment ]

Secondary Outcome Measures :
  1. Subject biopsy sampling [ Time Frame: Baseline and 9 months post treatment ]
    Histological examination of tissue samples pre-treatment and 9 months post treatment to assess safety and tolerability

  2. Satisfaction Questionnaires [ Time Frame: up to 12 months post treatment ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 OTC antiperspirants or deodorants
  • Receipt of Botox® or Dysport® within the past six months
  • Patients who refuse to stop using OTC 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811004


Locations
United States, California
Sasaki Advanced Aesthetic Medical Center
Pasadena, California, United States, 91105
Sponsors and Collaborators
Cynosure, Inc.
Investigators
Study Director: Patricia Krantz Cynosure, Inc.

Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01811004     History of Changes
Other Study ID Numbers: CYN12-GS-HH01
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs