Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Botox® Botox® |
Device: Nd:YAG Laser
Nd:YAG 1440 nm Laser
Device: Botox®
Botox®
|
| Experimental: miraDry® miraDry® |
Device: miraDry
miraDry
Device: Nd:YAG Laser
Nd:YAG 1440 nm Laser
|
| Experimental: Nd: YAG laser Nd: YAG laser 1440nm |
Device: Nd:YAG Laser
Nd:YAG 1440 nm Laser
|
Outcome Measures
Primary Outcome Measures
- 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.
- Change in Sweating Assessed Using Gravimetry [3 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.
- Change in Sweating Assessed Using Gravimetry [6 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.
- Change in Sweating Assessed Using Gravimetry [9 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sasaki Advanced Aesthetic Medical Center | Pasadena | California | United States | 91105 |
Sponsors and Collaborators
- Cynosure, Inc.
Investigators
- Study Director: Patricia Krantz, Cynosure, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CYN12-GS-HH01
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Nd: YAG Laser and miraDry | Nd: YAG Laser 1440nm and Botox |
|---|---|---|
| Arm/Group Description | Nd: YAG laser 1440nm and miraDry For each patient, one axilla was treated with the 1440 nm Diode laser and the opposite axilla was treated with miraDry. The subject is treated with miraDry at day 0, and again at day 90. Nd:YAG Laser: Nd:YAG 1440 nm Diode Laser with a Rep Rate of 25 Hz. Total energy around 1500 J per 5cm x 5cm sector. | Nd: YAG laser 1440nm and Botox For each patient, one axilla was treated with the 1440 nm Diode laser and the opposite axilla was treated with Botox. Nd:YAG Laser: Nd:YAG 1440 nm Diode Laser with a Rep Rate of 25 Hz. Total energy around 1500 J per 5cm x 5cm sector. |
| Period Title: Overall Study | ||
| STARTED | 9 | 8 |
| COMPLETED | 8 | 5 |
| NOT COMPLETED | 1 | 3 |
Baseline Characteristics
| Arm/Group Title | Nd: YAG Laser- miraDry | Nd: YAG Laser- Botox | Total |
|---|---|---|---|
| Arm/Group Description | Nd: YAG laser 1440nm miraDry: miraDry | Nd:YAG Laser: Nd:YAG 1440 nm Laser Botox®: Botox® | Total of all reporting groups |
| Overall Participants | 9 | 8 | 17 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
9
100%
|
8
100%
|
17
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
4
44.4%
|
5
62.5%
|
9
52.9%
|
| Male |
5
55.6%
|
3
37.5%
|
8
47.1%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Caucasian |
3
33.3%
|
5
62.5%
|
8
47.1%
|
| Hispanic |
0
0%
|
2
25%
|
2
11.8%
|
| Asian |
2
22.2%
|
0
0%
|
2
11.8%
|
| African American |
2
22.2%
|
0
0%
|
2
11.8%
|
| Puerto Rican/Caucasian |
1
11.1%
|
0
0%
|
1
5.9%
|
| African American/Caucasian |
1
11.1%
|
0
0%
|
1
5.9%
|
| Other (Not Specified) |
0
0%
|
1
12.5%
|
1
5.9%
|
| Fitzpatrick Skin Score (Count of Participants) | |||
| Fitzpatrick Skin Score I |
1
11.1%
|
0
0%
|
1
5.9%
|
| Fitzpatrick Skin Score II |
1
11.1%
|
3
37.5%
|
4
23.5%
|
| Fitzpatrick Skin Score III |
1
11.1%
|
3
37.5%
|
4
23.5%
|
| Fitzpatrick Skin Score IV |
4
44.4%
|
2
25%
|
6
35.3%
|
| Fitzpatrick Skin Score V |
2
22.2%
|
0
0%
|
2
11.8%
|
| Fitzpatrick Skin Score VI |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Change in Sweating Assessed Using Gravimetry |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| One subject in the Botox treatment was a no-show to their scheduled follow up. |
| Arm/Group Title | Botox® | miraDry® | Nd: YAG Laser |
|---|---|---|---|
| Arm/Group Description | Botox® Nd:YAG Laser: Nd:YAG 1440 nm Laser Botox®: Botox® | miraDry® miraDry: miraDry Nd:YAG Laser: Nd:YAG 1440 nm Laser | Nd: YAG laser 1440nm |
| Measure Participants | 7 | 9 | 16 |
| Mean (Standard Deviation) [mg] |
267.91
(432.53)
|
57.36
(33.55)
|
155.14
(263.53)
|
| Title | Change in Sweating Assessed Using Gravimetry |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Botox® | miraDry® | Nd: YAG Laser |
|---|---|---|---|
| Arm/Group Description | Botox® Nd:YAG Laser: Nd:YAG 1440 nm Laser Botox®: Botox® | miraDry® miraDry: miraDry Nd:YAG Laser: Nd:YAG 1440 nm Laser | Nd: YAG laser 1440nm |
| Measure Participants | 8 | 9 | 17 |
| Mean (Standard Deviation) [mg] |
231.89
(407.42)
|
53.59
(38.67)
|
22.72
(31.34)
|
| Title | Change in Sweating Assessed Using Gravimetry |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Botox® | miraDry® | Nd: YAG Laser |
|---|---|---|---|
| Arm/Group Description | Botox® Nd:YAG Laser: Nd:YAG 1440 nm Laser Botox®: Botox® | miraDry® miraDry: miraDry Nd:YAG Laser: Nd:YAG 1440 nm Laser | Nd: YAG laser 1440nm |
| Measure Participants | 8 | 9 | 17 |
| Mean (Standard Deviation) [mg] |
223.51
(380.18)
|
65.93
(46.48)
|
39.07
(42.11)
|
| Title | Change in Sweating Assessed Using Gravimetry |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The gravimetric test was not required for the 9 month follow up. |
| Arm/Group Title | Botox® | miraDry® | Nd: YAG Laser |
|---|---|---|---|
| Arm/Group Description | Botox® Nd:YAG Laser: Nd:YAG 1440 nm Laser Botox®: Botox® | miraDry® miraDry: miraDry Nd:YAG Laser: Nd:YAG 1440 nm Laser | Nd: YAG laser 1440nm |
| Measure Participants | 4 | 8 | 12 |
| Mean (Standard Deviation) [mg] |
99.49
(81.27)
|
67.06
(44.3)
|
28.36
(37.84)
|
Adverse Events
| Time Frame | Adverse Events occurring were collected throughout the study, around 18 months. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Botox® | miraDry® | Nd: YAG Laser | |||
| Arm/Group Description | Botox® and Nd:YAG Laser: 1440 nm Laser | miraDry® and Nd:YAG 1440 nm Laser | Nd: YAG laser: 1440nm | |||
All Cause Mortality |
||||||
| Botox® | miraDry® | Nd: YAG Laser | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/9 (0%) | 0/17 (0%) | |||
Serious Adverse Events |
||||||
| Botox® | miraDry® | Nd: YAG Laser | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/9 (0%) | 0/17 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Botox® | miraDry® | Nd: YAG Laser | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/8 (100%) | 9/9 (100%) | 17/17 (100%) | |||
| Nervous system disorders | ||||||
| Pain | 8/8 (100%) | 9/9 (100%) | 17/17 (100%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Numbness | 7/8 (87.5%) | 9/9 (100%) | 16/17 (94.1%) | |||
| Redness | 7/8 (87.5%) | 9/9 (100%) | 15/17 (88.2%) | |||
| Swelling | 8/8 (100%) | 9/9 (100%) | 15/17 (88.2%) | |||
| Bruising | 2/8 (25%) | 9/9 (100%) | 16/17 (94.1%) | |||
| Itching | 5/8 (62.5%) | 5/9 (55.6%) | 10/17 (58.8%) | |||
| Nodule | 7/8 (87.5%) | 9/9 (100%) | 13/17 (76.5%) | |||
| Hardness | 0/8 (0%) | 0/9 (0%) | 1/17 (5.9%) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
Results Point of Contact
| Name/Title | Jamie Trimper |
|---|---|
| Organization | Cynosure |
| Phone | 800-886-2966 |
| jamie.trimper@cynosure.com |
- CYN12-GS-HH01