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Investigation of Hyperhidrosis Treatment Using the Nd: YAG 1440nm Wavelength Laser

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ClinicalTrials.gov Identifier: NCT01810991
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : December 10, 2020
Last Update Posted : March 4, 2021
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 Laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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




Primary Outcome Measures :
  1. Percentage of Photographs Identified Accurately [ Time Frame: 3 Month Follow Up ]
    3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.

  2. Percentage of Photographs Identified Accurately [ Time Frame: 6 Month Follow Up ]
    3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.


Secondary Outcome Measures :
  1. Number of Participants With Changed and Unchanged Glands on Biopsy Sampling [ Time Frame: up to 3 months post last treatment ]
    Hematoxylin and eosin (H&E) staining was performed on all pre and post treatment biopsy samples and evaluated by a pathologist to determine if there was any change in the subjects' glands at baseline vs. post last treatment. Changes in glands are characterized by reduction in quantity and size, in addition to changes in shape.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A healthy non-smoking male or female between 18-56 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)

Exclusion Criteria:

  • Clinical diagnosis of secondary hyperhidrosis
  • Uncontrolled systemic disease
  • 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 over the counter 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 or planning to have any treatments for hyperhidrosis or surgery within the treatment area during the course of the study.
  • Allergies to medication or local anesthesia required for the procedure
  • A history of thrombophlebitis
  • A history of acute infections
  • A history of heart failure
  • Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
  • An intolerance to anesthesia
  • Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
  • Taking medications that are photosensitive
  • A history of keloid formation
  • Is pregnant or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the course of the study
  • Study subjects that can not maintain their pre-study exercise and diet routine over the course of the study

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): NCT01810991


Locations
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United States, New York
Juva Skin and Laser Center
New York, New York, United States, 10021
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: NCT01810991    
Other Study ID Numbers: CYN12-1440-BK-HID1
First Posted: March 14, 2013    Key Record Dates
Results First Posted: December 10, 2020
Last Update Posted: March 4, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases