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A Non-Interventional Study To Assess Sweating

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ClinicalTrials.gov Identifier: NCT02552199
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : October 26, 2015
Sponsor:
Information provided by (Responsible Party):
Brickell Biotech, Inc.

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.

Condition or disease Intervention/treatment
Hyperhidrosis 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.


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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals
Study Start Date : September 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Group/Cohort Intervention/treatment
with hyperhidrosis
Patients with primary hyperhidrosis
Other: gravimetric
healthy
Healthy adult patients
Other: gravimetric



Primary Outcome Measures :
  1. Gravimetric measurement by weight [ Time Frame: 14 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with palmar hyperhidrosis and healthy subjects
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552199


Locations
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United States, California
Carpinteria Dermatology
Carpinteria, California, United States, 93013
Sponsors and Collaborators
Brickell Biotech, Inc.
Investigators
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Principal Investigator: Patricia S Walker, M.D.,Ph.D. Brickell

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Responsible Party: Brickell Biotech, Inc.
ClinicalTrials.gov Identifier: NCT02552199     History of Changes
Other Study ID Numbers: BBI-4000-EM-101
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases