A Non-Interventional Study To Assess Sweating

Botanix Pharmaceuticals28 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hyperhidrosis

Interventions

gravimetricOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Carpinteria Dermatology

Carpinteria, California, United States

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).

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.

Data from ClinicalTrials.gov

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