A Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperhidrosis
- Sponsor
- Botanix Pharmaceuticals
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) Between Subject Groups (Adult Patients With Hyperhidrosis Versus Healthy Adult Volunteers).
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Females should not be pregnant or lactating.
- •For subjects with palmar hyperhidrosis: Primary palmar hyperhidrosis of at least 6 months's duration and Hyperhidrosis disease severity score of 3 or 4 at baseline
- •For healthy participants: no history or current report of hyperhidrosis and Hyperhidrosis disease severity score of 1 at baseline
Exclusion Criteria
- •Recent therapeutic interventions or treatments for palmar hyperhidrosis
- •Any major illness within 30 days before the screening
- •Females who are pregnant, lactating, or planning a pregnancy
Outcomes
Primary Outcomes
Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) 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.
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).