A Non-Interventional Study To Assess Sweating

Hyperhidrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552199
• Other study ID #: BBI-4000-EM-101
• Status: Completed
• Start date: September 2015
• Est. completion date: October 2015

Study information

• Verified date: February 2024
• Source: Botanix Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Other:
• gravimetric

Locations

Country	Name	City	State
United States	Carpinteria Dermatology	Carpinteria	California

Sponsors (1)

Lead Sponsor	Collaborator
Botanix Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.