A Non-Interventional Study To Assess Sweating

Completed

• Conditions: Hyperhidrosis
• Interventions: Other: gravimetric

• Registration Number: NCT02552199
• Lead Sponsor: Botanix Pharmaceuticals

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-17
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2022-12-22
• Results First Submitted QC: 2022-12-22
• Results First Posted: 2023-10-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with hyperhidrosis	gravimetric	Patients with primary palmar hyperhidrosis
healthy	gravimetric	Healthy adult patients

Primary Outcome Measures

Name	Time	Method
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.	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).

Trial Locations

Locations (1)

Carpinteria Dermatology; 🇺🇸 Carpinteria, California, United States