A Non-Interventional Study To Assess Sweating

Botanix Pharmaceuticals

Status: Completed

Conditions: Hyperhidrosis

Treatments: Other: gravimetric

Study type: Observational

Funder types: Industry

Identifiers

NCT02552199

BBI-4000-EM-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 2 patient groups

with hyperhidrosis

Description:

Patients with primary palmar hyperhidrosis

Treatment:

Other: gravimetric

healthy

Description:

Healthy adult patients

Treatment:

Other: gravimetric