An observational study in Hyperhidrosis, sponsored by Botanix Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Botanix Pharmaceuticals · Observational
To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.
This is a Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals .
The objective of this study is to determine the threshold gravimetric measurement for subjects with palmar hyperhidrosis.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
Browse Hyperhidrosis studies →Botanix Pharmaceuticals is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
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Subjects with palmar hyperhidrosis and healthy subjects
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with primary palmar hyperhidrosis
Other: gravimetric
Healthy adult patients
Other: gravimetric
Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) Between Subject Groups (Adult Patients With Hyperhidrosis Versus Healthy Adult Volunteers).
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).
Time frame: Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms.
| Milestone | With Hyperhidrosis | Healthy |
|---|---|---|
| Started | 17 | 11 |
| Completed | 17 | 11 |
| Not completed | 0 | 0 |
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).
| grams | With Hyperhidrosis | Healthy |
|---|---|---|
| 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 ± 0.8300 | 0.1762 ± 0.1010 |
Collected over 14 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| With Hyperhidrosis | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Healthy | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | With Hyperhidrosis | Healthy | Total |
|---|---|---|---|
| Mean | 40.59 ± 16.33 | 47.91 ± 14.50 | 43.46 ± 15.78 |
| Sex: Female, Male(Participants) | With Hyperhidrosis | Healthy | Total |
|---|---|---|---|
| Female | 14 | 6 | 20 |
| Male | 3 | 5 | 8 |
| Ethnicity (NIH/OMB)(Participants) | With Hyperhidrosis | Healthy | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 4 | 9 |
| Not Hispanic or Latino | 12 | 7 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | With Hyperhidrosis | Healthy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 9 | 10 | 19 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 4 | 1 | 5 |
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Botanix Pharmaceuticals