A Non-Interventional Study To Assess Sweating

NCT02552199 | Completed Results

• 1 other identifier: BBI-4000-EM-101
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

with hyperhidrosis

Patients with primary palmar hyperhidrosis

Other: gravimetric

healthy

Healthy adult patients

Other: gravimetric

Interventions

gravimetric OTHER

healthy; with hyperhidrosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with palmar hyperhidrosis and healthy subjects

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Botanix Pharmaceuticals: lead

Study Sites (1)

Carpinteria Dermatology

Carpinteria, California, 93013, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Anthony Robinson MS CRNP
• Organization: Botanix Pharmaceuticals

trials@botanixpharma.com

+1 (445) 300-3403

Study Officials

• Patricia S Walker, M.D.,Ph.D.

  Botanix Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 15, 2024
• Results First Posted: October 23, 2023

Record last verified: 2024-02

Locations

US (1)