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Trial Outcomes & Findings for A Non-Interventional Study To Assess Sweating (NCT NCT02552199)

NCT ID: NCT02552199

Last Updated: 2024-02-15

Results Overview

Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms. An individual palm GMSP was determined by subtracting the Weight (g) of individual gauze in contact with palm after five minutes - Weight (g) of individual gauze prior to palmar contact. For this analysis, each participant could provide two results (1 Total GMSP/occasion) as: Total GMSP 1 \[g\] = Right palm GMSP 1 \[g\] + Left palm GMSP 1 \[g\] Total GMSP 2 \[g\] = Right palm GMSP 2 \[g\] + Left Palm GMSP 2 \[g\] Mean average \[g\] (standard deviation) Total GMSPs were compared between Subject Groups (adult patients with hyperhidrosis versus healthy adult volunteers).

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms.

Results posted on

2024-02-15

Participant Flow

Participant milestones

Participant milestones
Measure
With Hyperhidrosis
Patients with primary palmar hyperhidrosis gravimetric
Healthy
Healthy adult patients gravimetric
Overall Study
STARTED
17
11
Overall Study
COMPLETED
17
11
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Non-Interventional Study To Assess Sweating

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
With Hyperhidrosis
n=17 Participants
Patients with primary palmar hyperhidrosis gravimetric
Healthy
n=11 Participants
Healthy adult patients gravimetric
Total
n=28 Participants
Total of all reporting groups
Age, Continuous
40.59 years
STANDARD_DEVIATION 16.33 • n=99 Participants
47.91 years
STANDARD_DEVIATION 14.50 • n=107 Participants
43.46 years
STANDARD_DEVIATION 15.78 • n=206 Participants
Sex: Female, Male
Female
14 Participants
n=99 Participants
6 Participants
n=107 Participants
20 Participants
n=206 Participants
Sex: Female, Male
Male
3 Participants
n=99 Participants
5 Participants
n=107 Participants
8 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=99 Participants
4 Participants
n=107 Participants
9 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=99 Participants
7 Participants
n=107 Participants
19 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Asian
2 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
White
9 Participants
n=99 Participants
10 Participants
n=107 Participants
19 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
n=99 Participants
1 Participants
n=107 Participants
5 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms.

Population: Full analysis set including all enrolled subjects.

Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms. An individual palm GMSP was determined by subtracting the Weight (g) of individual gauze in contact with palm after five minutes - Weight (g) of individual gauze prior to palmar contact. For this analysis, each participant could provide two results (1 Total GMSP/occasion) as: Total GMSP 1 \[g\] = Right palm GMSP 1 \[g\] + Left palm GMSP 1 \[g\] Total GMSP 2 \[g\] = Right palm GMSP 2 \[g\] + Left Palm GMSP 2 \[g\] Mean average \[g\] (standard deviation) Total GMSPs were compared between Subject Groups (adult patients with hyperhidrosis versus healthy adult volunteers).

Outcome measures

Outcome measures
Measure
With Hyperhidrosis
n=17 Participants
Patients with primary palmar hyperhidrosis gravimetric
Healthy
n=11 Participants
Healthy adult patients gravimetric
Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) Between Subject Groups (Adult Patients With Hyperhidrosis Versus Healthy Adult Volunteers).
0.7687 grams
Standard Deviation 0.8300
0.1762 grams
Standard Deviation 0.1010

Adverse Events

With Hyperhidrosis

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony Robinson MS CRNP

Botanix Pharmaceuticals

Phone: +1 (445) 300-3403

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place