Clinical trial NCT01811004: Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperhidrosis
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Purpose of the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary Hyperhidrosis.


Eligibility criteria: Inclusion Criteria:

* A healthy non-smoking male or female between 18-70 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) a. Gravimetric \>50mg/5min in each axilla

Exclusion Criteria:

* Clinical diagnosis of secondary hyperhidrosis
* Uncontrolled systemic disease or infection
* 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 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 Keflex

Primary outcomes:
measure: Change in Sweating Assessed Using Gravimetry
timeFrame: 1 month follow up
measure: Change in Sweating Assessed Using Gravimetry
timeFrame: 3 month follow up
measure: Change in Sweating Assessed Using Gravimetry
timeFrame: 6 month follow up
measure: Change in Sweating Assessed Using Gravimetry
timeFrame: 9 month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Sasaki Advanced Aesthetic Medical Center
state: California
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References: