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Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02100072
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm wavelength laser for the treatment of primary hyperhidrosis of the axilla.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Device: Nd:YAG 1440 nm laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis
Study Start Date : June 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: Nd:YAG 1440 nm laser Device: Nd:YAG 1440 nm laser



Primary Outcome Measures :
  1. Starch Iodine test to measure improvement [ Time Frame: up to 6 months post treatment ]

Secondary Outcome Measures :
  1. Assess safety of treatment through collection of events [ Time Frame: up to 6 months post last treatment ]
    Patients will be given a 1 week diary to record any side effects they may after treatment and at all visits



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A healthy non-smoking male or female between 18-55 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)

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 Doxycycline

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): NCT02100072


Locations
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United States, Massachusetts
Skin Care Physicians
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Cynosure, Inc.
Investigators
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Study Director: Patricia Krantz Cynosure, Inc.

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Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT02100072     History of Changes
Other Study ID Numbers: CYN13-MK-HH01
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases