Hyperhidrosis
Conditions
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.
Interventions
DEVICENd:YAG 1440 nm laser
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* A healthy non-smoking male or female between 18-55 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 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 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 * 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 Doxycycline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sweating Assessed Using Gravimetry | Baseline and 3 months post baseline | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. To calculate the change between the baseline and 3 months post baselines, the values taken at these 2 time points are subtracted from each other. A negative value means that there has been a decrease in gravimetric weight since the baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nd:YAG 1440 nm Laser Nd:YAG 1440 nm laser | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Nd:YAG 1440 nm Laser |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type I | 0 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type II | 0 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type III | 3 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type IV | 0 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type V | 2 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type VI | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 3 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Change in Sweating Assessed Using Gravimetry
A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. To calculate the change between the baseline and 3 months post baselines, the values taken at these 2 time points are subtracted from each other. A negative value means that there has been a decrease in gravimetric weight since the baseline.
Time frame: Baseline and 3 months post baseline
Population: 1 subject was incapable of attending the follow up visit, so their gravimetric measurement was not able to be obtained. They were able to answer other follow up questions via the phone, however.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nd:YAG 1440 nm Laser | Change in Sweating Assessed Using Gravimetry | Average Gravimetric Change (Left Side) | -104.50 mg | Standard Deviation 156.57 |
| Nd:YAG 1440 nm Laser | Change in Sweating Assessed Using Gravimetry | Average Gravimetric Change (Right Side) | -90.85 mg | Standard Deviation 131.84 |