A Non-Interventional Study To Assess Sweating

To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.

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Key information

Conditions

Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Carpinteria Dermatology

Carpinteria, California, 93013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gravimetric

Other

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).

Sponsors and collaborators

Lead sponsor

Botanix Pharmaceuticals

Industry

Registry information

Official study title

A Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Sep 17, 2015
Registry last updated: Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed