Trial Outcomes & Findings for Evaluation of N-SWEAT Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating (NCT NCT04599907)
NCT ID: NCT04599907
Last Updated: 2023-09-07
Results Overview
Number of patients with Adverse Events and/or Skin reactions following patch treatment
COMPLETED
NA
120 participants
4 weeks
2023-09-07
Participant Flow
Participant milestones
| Measure |
Roll-In Cohort: N-SWEAT Patch
Subjects will be treated with N-SWEAT Patch
Roll-In Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for 10 subjects
|
Randomized Cohort: N-SWEAT Patch
Subjects will be treated with N-SWEAT Patch
Randomized Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
|
Randomized Cohort: Sham Patch
Subjects will undergo identical procedure with an inactive sham device
Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
53
|
57
|
|
Overall Study
COMPLETED
|
9
|
45
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
8
|
6
|
Reasons for withdrawal
| Measure |
Roll-In Cohort: N-SWEAT Patch
Subjects will be treated with N-SWEAT Patch
Roll-In Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for 10 subjects
|
Randomized Cohort: N-SWEAT Patch
Subjects will be treated with N-SWEAT Patch
Randomized Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
|
Randomized Cohort: Sham Patch
Subjects will undergo identical procedure with an inactive sham device
Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Evaluation of N-SWEAT Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating
Baseline characteristics by cohort
| Measure |
Roll-In Cohort: N-SWEAT Patch
n=10 Participants
Subjects will be treated with N-SWEAT Patch
Roll-In Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for 10 subjects
|
Randomized Cohort: N-SWEAT Patch
n=53 Participants
Subjects will be treated with N-SWEAT Patch
Randomized Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
|
Randomized Cohort: Sham Patch
n=57 Participants
Subjects will undergo identical procedure with an inactive sham device
Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
120 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 15.3 • n=99 Participants
|
32.6 years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
34.4 years
STANDARD_DEVIATION 8.4 • n=206 Participants
|
34.3 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
73 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
105 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
77 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
53 participants
n=107 Participants
|
57 participants
n=206 Participants
|
120 participants
n=7 Participants
|
|
HDSS
HDSS 3
|
4 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
|
HDSS
HDSS 4
|
6 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
70 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: All subjects treated with the N-SWEAT Patch (roll-in and randomized) were combined into a single population for the safety analysis.
Number of patients with Adverse Events and/or Skin reactions following patch treatment
Outcome measures
| Measure |
N-SWEAT Patch Treated
n=63 Participants
Subjects will be treated with N-SWEAT Patch
Randomized Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
|
Randomized Cohort: Sham Patch
n=57 Participants
Subjects will undergo identical procedure with an inactive sham device
Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group
|
|---|---|---|
|
Safety of the N-SWEAT Patch
|
14 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: This was conducted on the Efficacy Cohort which included only randomized/blinded subjects. Those treated in the roll-in cohort was not included in the efficacy analyses were aware of the treatment arm to which they were assigned. Additionally, subjects who were found to have been enrolled while taking a conflicting medication were excluded from the efficacy analysis in order to isolate the true device effect.
Achievement of Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at 4 weeks. HDSS is a disease-specific diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS 3 or 4 are generally considered to have a clinically significant case and those with HDSS 1 or 2 are considered to have mild to no evidence of hyperhidrosis. SCALE: 1 - My sweating is never noticeable and never interferes with my daily activities 2- My sweating is tolerable but sometimes interferes with my daily activities 3- My sweating is barely tolerable and frequently interferes with my daily activities 4- My sweating is intolerable and and always interferes with my daily activities
Outcome measures
| Measure |
N-SWEAT Patch Treated
n=44 Participants
Subjects will be treated with N-SWEAT Patch
Randomized Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
|
Randomized Cohort: Sham Patch
n=43 Participants
Subjects will undergo identical procedure with an inactive sham device
Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group
|
|---|---|---|
|
Effectiveness of the N-SWEAT Patch to Change Subjects From an HDSS 3 or 4 at Baseline to HDSS 1 or 2 at 4 Weeks
|
28 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The efficacy population was defined in efficacy primary outcome section. It included randomized subjects who were not taking any conflicting medications.
Two Quality of Life (QoL) Assessments were conducted as part of this endpoint. The Level of Bother: Subjects were asked how much their sweat bothered them on a Scale of 1 (not at all bothered by sweating) to 5 (extremely bothered by sweating). The Impact of Sweat on Daily Activities: Subjects were asked how much their sweating impacts their daily activities on a scale of 1 (not at all impacted) to 5 (extremely impacted). The mean improvement of each of these was calculated by comparing the mean baseline level to the mean level at 4 weeks. The mean change in the level of improvement was analyzed for significance. A larger decrease in these levels, i.e. less bother and less impact, (indicated by a larger negative number) will show the most improvement in QoL.
Outcome measures
| Measure |
N-SWEAT Patch Treated
n=44 Participants
Subjects will be treated with N-SWEAT Patch
Randomized Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
|
Randomized Cohort: Sham Patch
n=43 Participants
Subjects will undergo identical procedure with an inactive sham device
Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group
|
|---|---|---|
|
Mean Change in the Quality of Life. Assessed by Evaluating How Much Sweat Bothers or Impacts the Daily Life of Patients (a Higher Score Means More Bother and More Impact)
Change in the Level of Bother due to Sweat
|
-1.52 score on a scale
Interval -1.88 to -1.16
|
-0.61 score on a scale
Interval -0.98 to -0.25
|
|
Mean Change in the Quality of Life. Assessed by Evaluating How Much Sweat Bothers or Impacts the Daily Life of Patients (a Higher Score Means More Bother and More Impact)
Change in Level of Impact of Sweat on Daily Activities
|
-1.44 score on a scale
Interval -1.77 to -1.1
|
-0.57 score on a scale
Interval -0.91 to -0.23
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: This endpoint defined by the study protocol was for at least 50% of the treated subjects to achieve a reduction in GSP of 50% or more, thus, the sham population was not included in this analysis. Moreover, the GSP measurement (unlike the HDSS or the QoL measurements) required the subjects to report back to the clinic at 4-weeks. Only 43 of the 44 N-SWEAT treated subjects in the efficacy population reported for the 4-week visit.
Gravimetric Sweat Production (GSP) measures the amount of sweat that is produced in a 5-minute period. The percentage of treated subjects with at least a 50% reduction in mean GSP (mean of both axilla) from baseline to 4 weeks was analyzed for this endpoint.
Outcome measures
| Measure |
N-SWEAT Patch Treated
n=43 Participants
Subjects will be treated with N-SWEAT Patch
Randomized Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
|
Randomized Cohort: Sham Patch
Subjects will undergo identical procedure with an inactive sham device
Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group
|
|---|---|---|
|
Percentage of Patients With a Mean Change in Gravimetric Sweat Production (GSP) Indicating That Sweating After Treatment is Cut in Half From Pre-treatment Sweat
|
26 Participants
|
—
|
SECONDARY outcome
Timeframe: 4-weeksPatients with a 2-point decrease in HDSS indicate improvement in sweating. HDSS is a disease-specific diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS 3 or 4 are generally considered to have a clinically significant case and those with HDSS 1 or 2 are considered to have mild to no evidence of hyperhidrosis. SCALE: 1 - My sweating is never noticeable and never interferes with my daily activities 2- My sweating is tolerable but sometimes interferes with my daily activities 3- My sweating is barely tolerable and frequently interferes with my daily activities 4- My sweating is intolerable and always interferes with my daily activities
Outcome measures
| Measure |
N-SWEAT Patch Treated
n=44 Participants
Subjects will be treated with N-SWEAT Patch
Randomized Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
|
Randomized Cohort: Sham Patch
n=43 Participants
Subjects will undergo identical procedure with an inactive sham device
Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group
|
|---|---|---|
|
Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment
|
19 Participants
|
7 Participants
|
Adverse Events
N-SWEAT Patch
Sham Patch
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N-SWEAT Patch
n=63 participants at risk
Subjects will be treated with N-SWEAT Patch
Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
|
Sham Patch
n=57 participants at risk
Subjects will undergo identical procedure with an inactive sham device
Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group
|
|---|---|---|
|
Injury, poisoning and procedural complications
Device or Treatment Related Events
|
22.2%
14/63 • Number of events 17 • Adverse Events were collected for 12 weeks, the total duration of the study
Definitions were consistent with clinicaltrials.gov.
|
7.0%
4/57 • Number of events 4 • Adverse Events were collected for 12 weeks, the total duration of the study
Definitions were consistent with clinicaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place