A Non-Interventional Study To Assess Sweating

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

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

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Other: gravimetric

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 Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • California
    • Carpinteria, California, United States, 93013
      • Carpinteria Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects with palmar hyperhidrosis and healthy subjects

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy; Healthy adult patients	Other: gravimetric
with hyperhidrosis; Patients with primary palmar hyperhidrosis	Other: gravimetric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Botanix Pharmaceuticals
• Investigators: Study Director: Patricia S Walker, M.D.,Ph.D., Botanix Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimated): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: BBI-4000-EM-101