Hyperhidrosis
Conditions
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.
Interventions
Sponsors
Cynosure, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sweating Assessed Using Gravimetry | 1 month follow up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nd: YAG Laser- miraDry Nd: YAG laser 1440nm
miraDry: miraDry | 9 |
| Nd: YAG Laser- Botox Nd:YAG Laser: Nd:YAG 1440 nm Laser
Botox®: Botox® | 8 |
| Total | 17 |
Baseline characteristics
| Characteristic | Nd: YAG Laser- miraDry | Nd: YAG Laser- Botox | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 8 Participants | 17 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score I | 1 Participants | 0 Participants | 1 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score II | 1 Participants | 3 Participants | 4 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score III | 1 Participants | 3 Participants | 4 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score IV | 4 Participants | 2 Participants | 6 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score V | 2 Participants | 0 Participants | 2 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score VI | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American/Caucasian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 3 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other (Not Specified) | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Puerto Rican/Caucasian | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 | 0 / 17 |
| other Total, other adverse events | 8 / 8 | 9 / 9 | 17 / 17 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 | 0 / 17 |
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.
Time frame: 1 month follow up
Population: One subject in the Botox treatment was a no-show to their scheduled follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botox® | Change in Sweating Assessed Using Gravimetry | 267.91 mg | Standard Deviation 432.53 |
| miraDry® | Change in Sweating Assessed Using Gravimetry | 57.36 mg | Standard Deviation 33.55 |
| Nd: YAG Laser | Change in Sweating Assessed Using Gravimetry | 155.14 mg | Standard Deviation 263.53 |
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.
Time frame: 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botox® | Change in Sweating Assessed Using Gravimetry | 231.89 mg | Standard Deviation 407.42 |
| miraDry® | Change in Sweating Assessed Using Gravimetry | 53.59 mg | Standard Deviation 38.67 |
| Nd: YAG Laser | Change in Sweating Assessed Using Gravimetry | 22.72 mg | Standard Deviation 31.34 |
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.
Time frame: 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botox® | Change in Sweating Assessed Using Gravimetry | 223.51 mg | Standard Deviation 380.18 |
| miraDry® | Change in Sweating Assessed Using Gravimetry | 65.93 mg | Standard Deviation 46.48 |
| Nd: YAG Laser | Change in Sweating Assessed Using Gravimetry | 39.07 mg | Standard Deviation 42.11 |
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.
Time frame: 9 month follow up
Population: The gravimetric test was not required for the 9 month follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botox® | Change in Sweating Assessed Using Gravimetry | 99.49 mg | Standard Deviation 81.27 |
| miraDry® | Change in Sweating Assessed Using Gravimetry | 67.06 mg | Standard Deviation 44.3 |
| Nd: YAG Laser | Change in Sweating Assessed Using Gravimetry | 28.36 mg | Standard Deviation 37.84 |