Trial Outcomes & Findings for Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis (NCT NCT01811004)
NCT ID: NCT01811004
Last Updated: 2021-01-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
1 month follow up
Results posted on
2021-01-22
Participant Flow
Participant milestones
| Measure |
Nd: YAG Laser and miraDry
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis
Baseline characteristics by cohort
| Measure |
Nd: YAG Laser- miraDry
n=9 Participants
Nd: YAG laser 1440nm
miraDry: miraDry
|
Nd: YAG Laser- Botox
n=8 Participants
Nd:YAG Laser: Nd:YAG 1440 nm Laser
Botox®: Botox®
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Puerto Rican/Caucasian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American/Caucasian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other (Not Specified)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Score I
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Score II
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Score III
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Score IV
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Score V
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Score VI
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month follow upPopulation: One subject in the Botox treatment was a no-show to their scheduled 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.
Outcome measures
| Measure |
Botox®
n=7 Participants
Botox®
Nd:YAG Laser: Nd:YAG 1440 nm Laser
Botox®: Botox®
|
miraDry®
n=9 Participants
miraDry®
miraDry: miraDry
Nd:YAG Laser: Nd:YAG 1440 nm Laser
|
Nd: YAG Laser
n=16 Participants
Nd: YAG laser 1440nm
|
|---|---|---|---|
|
Change in Sweating Assessed Using Gravimetry
|
267.91 mg
Standard Deviation 432.53
|
57.36 mg
Standard Deviation 33.55
|
155.14 mg
Standard Deviation 263.53
|
PRIMARY outcome
Timeframe: 3 month follow upA 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.
Outcome measures
| Measure |
Botox®
n=8 Participants
Botox®
Nd:YAG Laser: Nd:YAG 1440 nm Laser
Botox®: Botox®
|
miraDry®
n=9 Participants
miraDry®
miraDry: miraDry
Nd:YAG Laser: Nd:YAG 1440 nm Laser
|
Nd: YAG Laser
n=17 Participants
Nd: YAG laser 1440nm
|
|---|---|---|---|
|
Change in Sweating Assessed Using Gravimetry
|
231.89 mg
Standard Deviation 407.42
|
53.59 mg
Standard Deviation 38.67
|
22.72 mg
Standard Deviation 31.34
|
PRIMARY outcome
Timeframe: 6 month follow upA 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.
Outcome measures
| Measure |
Botox®
n=8 Participants
Botox®
Nd:YAG Laser: Nd:YAG 1440 nm Laser
Botox®: Botox®
|
miraDry®
n=9 Participants
miraDry®
miraDry: miraDry
Nd:YAG Laser: Nd:YAG 1440 nm Laser
|
Nd: YAG Laser
n=17 Participants
Nd: YAG laser 1440nm
|
|---|---|---|---|
|
Change in Sweating Assessed Using Gravimetry
|
223.51 mg
Standard Deviation 380.18
|
65.93 mg
Standard Deviation 46.48
|
39.07 mg
Standard Deviation 42.11
|
PRIMARY outcome
Timeframe: 9 month follow upPopulation: The gravimetric test was not required for the 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.
Outcome measures
| Measure |
Botox®
n=4 Participants
Botox®
Nd:YAG Laser: Nd:YAG 1440 nm Laser
Botox®: Botox®
|
miraDry®
n=8 Participants
miraDry®
miraDry: miraDry
Nd:YAG Laser: Nd:YAG 1440 nm Laser
|
Nd: YAG Laser
n=12 Participants
Nd: YAG laser 1440nm
|
|---|---|---|---|
|
Change in Sweating Assessed Using Gravimetry
|
99.49 mg
Standard Deviation 81.27
|
67.06 mg
Standard Deviation 44.3
|
28.36 mg
Standard Deviation 37.84
|
Adverse Events
Botox®
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
miraDry®
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Nd: YAG Laser
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Botox®
n=8 participants at risk
Botox® and Nd:YAG Laser: 1440 nm Laser
|
miraDry®
n=9 participants at risk
miraDry® and Nd:YAG 1440 nm Laser
|
Nd: YAG Laser
n=17 participants at risk
Nd: YAG laser: 1440nm
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Numbness
|
87.5%
7/8 • Adverse Events occurring were collected throughout the study, around 18 months.
|
100.0%
9/9 • Adverse Events occurring were collected throughout the study, around 18 months.
|
94.1%
16/17 • Adverse Events occurring were collected throughout the study, around 18 months.
|
|
Nervous system disorders
Pain
|
100.0%
8/8 • Adverse Events occurring were collected throughout the study, around 18 months.
|
100.0%
9/9 • Adverse Events occurring were collected throughout the study, around 18 months.
|
100.0%
17/17 • Adverse Events occurring were collected throughout the study, around 18 months.
|
|
Skin and subcutaneous tissue disorders
Redness
|
87.5%
7/8 • Adverse Events occurring were collected throughout the study, around 18 months.
|
100.0%
9/9 • Adverse Events occurring were collected throughout the study, around 18 months.
|
88.2%
15/17 • Adverse Events occurring were collected throughout the study, around 18 months.
|
|
Skin and subcutaneous tissue disorders
Swelling
|
100.0%
8/8 • Adverse Events occurring were collected throughout the study, around 18 months.
|
100.0%
9/9 • Adverse Events occurring were collected throughout the study, around 18 months.
|
88.2%
15/17 • Adverse Events occurring were collected throughout the study, around 18 months.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
25.0%
2/8 • Adverse Events occurring were collected throughout the study, around 18 months.
|
100.0%
9/9 • Adverse Events occurring were collected throughout the study, around 18 months.
|
94.1%
16/17 • Adverse Events occurring were collected throughout the study, around 18 months.
|
|
Skin and subcutaneous tissue disorders
Itching
|
62.5%
5/8 • Adverse Events occurring were collected throughout the study, around 18 months.
|
55.6%
5/9 • Adverse Events occurring were collected throughout the study, around 18 months.
|
58.8%
10/17 • Adverse Events occurring were collected throughout the study, around 18 months.
|
|
Skin and subcutaneous tissue disorders
Nodule
|
87.5%
7/8 • Adverse Events occurring were collected throughout the study, around 18 months.
|
100.0%
9/9 • Adverse Events occurring were collected throughout the study, around 18 months.
|
76.5%
13/17 • Adverse Events occurring were collected throughout the study, around 18 months.
|
|
Skin and subcutaneous tissue disorders
Hardness
|
0.00%
0/8 • Adverse Events occurring were collected throughout the study, around 18 months.
|
0.00%
0/9 • Adverse Events occurring were collected throughout the study, around 18 months.
|
5.9%
1/17 • Adverse Events occurring were collected throughout the study, around 18 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
- Publication restrictions are in place
Restriction type: OTHER