Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 59 of 166 for:    "Sweat Gland Disease"

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

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: NCT01810991
Recruitment Status : Completed
First Posted : March 14, 2013
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 Laser Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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. Photographic evaluation as a measure of improvement [ Time Frame: up to 6 months post treatment ]
    2D photography to be taken at various time points.


Secondary Outcome Measures :
  1. Subject biopsy sampling [ Time Frame: up to 3 months post last treatment ]
    Histological examination of tissue samples pre-treatment and post-treatment as a measure of safety and tolerability



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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 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 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 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
Layout table for location information
United States, New York
Juva Skin and Laser Center
New York, New York, United States, 10021
Sponsors and Collaborators
Cynosure, Inc.
Investigators
Layout table for investigator information
Study Director: Patricia Krantz Cynosure, Inc.

Layout table for additonal information
Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01810991     History of Changes
Other Study ID Numbers: CYN12-1440-BK-HID1
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases