Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis

NCT ID: NCT01811004

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-07-31

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.

Conditions

Hyperhidrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Botox®

Botox®

Group Type: EXPERIMENTAL

Nd:YAG Laser

Intervention Type: DEVICE

Nd:YAG 1440 nm Laser

Botox®

Intervention Type: DEVICE

Botox®

miraDry®

miraDry®

Group Type: EXPERIMENTAL

miraDry

Intervention Type: DEVICE

miraDry

Nd:YAG Laser

Intervention Type: DEVICE

Nd:YAG 1440 nm Laser

Nd: YAG laser

Nd: YAG laser 1440nm

Group Type: EXPERIMENTAL

Nd:YAG Laser

Intervention Type: DEVICE

Nd:YAG 1440 nm Laser

Interventions

miraDry

miraDry

Intervention Type: DEVICE

Nd:YAG Laser

Nd:YAG 1440 nm Laser

Intervention Type: DEVICE

Botox®

Botox®

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cynosure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Krantz

Role: STUDY_DIRECTOR

Cynosure, Inc.

Locations

Sasaki Advanced Aesthetic Medical Center

Pasadena, California, United States

Countries

United States

Other Identifiers

CYN12-GS-HH01

Identifier Type: -

Identifier Source: org_study_id