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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.
ClinicalTrials.gov Identifier:
NCT01811004
First received: December 6, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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 Intervention
Hyperhidrosis
Device: miraDry
Device: Nd:YAG Laser
Device: Botox®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Cynosure, Inc.:

Primary Outcome Measures:
  • Comparison of Amount of Sweat Produced [ Time Frame: up to 12 months post treatment ] [ Designated as safety issue: No ]

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

  • Satisfaction Questionnaires [ Time Frame: up to 12 months post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  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: 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.
  More Information

No publications provided

Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01811004     History of Changes
Other Study ID Numbers: CYN12-GS-HH01
Study First Received: December 6, 2012
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 10, 2014