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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with hyperhidrosis | Patients with primary palmar hyperhidrosis |
| |
| healthy | Healthy adult patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gravimetric | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with palmar hyperhidrosis and healthy subjects
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| Name | Affiliation | Role |
|---|---|---|
| Patricia S Walker, M.D.,Ph.D. | Botanix Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carpinteria Dermatology | Carpinteria | California | 93013 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | With Hyperhidrosis | Patients with primary palmar hyperhidrosis gravimetric |
| FG001 | Healthy | Healthy adult patients gravimetric |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | With Hyperhidrosis | Patients with primary palmar hyperhidrosis gravimetric |
| BG001 | Healthy | Healthy adult patients gravimetric |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Full analysis set including all enrolled subjects. | Posted | Mean | Standard Deviation | grams | Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms. |
14 days
Due to the short duration and non-interventional nature of the study, only procedure-related AEs were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | With Hyperhidrosis | Patients with primary palmar hyperhidrosis gravimetric | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Robinson MS CRNP | Botanix Pharmaceuticals | +1 (445) 300-3403 | trials@botanixpharma.com |
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| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | With Hyperhidrosis | Patients with primary palmar hyperhidrosis gravimetric |
| OG001 | Healthy | Healthy adult patients gravimetric |
|
|
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Healthy | Healthy adult patients gravimetric | 0 | 11 | 0 | 11 | 0 | 11 |
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