Clinical trial NCT01810991: Investigation of Hyperhidrosis Treatment Using the Nd: YAG 1440nm Wavelength Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HYPERHIDROSIS
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Photographs Identified Accurately
timeFrame: 3 Month Follow Up
measure: Percentage of Photographs Identified Accurately
timeFrame: 6 Month Follow Up
Secondary outcomes:
measure: Number of Participants With Changed and Unchanged Glands on Biopsy Sampling
timeFrame: up to 3 months post last treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Juva Skin and Laser Center
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References: