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Completed

NCT Number: NCT01810991

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juva Skin and Laser Center

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nd:Yag Laser

Device

Nd:YAG 1440nm Laser

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 14, 2013
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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