Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Non-Interventional Study To Assess Sweating

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date September 15, 2015
First Posted Date September 17, 2015
Last Update Posted Date October 26, 2015
Study Start Date September 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2015)
Gravimetric measurement by weight [ Time Frame: 14 Days ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02552199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Non-Interventional Study To Assess Sweating
Official Title A Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects with palmar hyperhidrosis and healthy subjects
Condition Hyperhidrosis
Intervention Other: gravimetric
Study Groups/Cohorts
  • with hyperhidrosis
    Patients with primary hyperhidrosis
    Intervention: Other: gravimetric
  • healthy
    Healthy adult patients
    Intervention: Other: gravimetric
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 23, 2015)
28
Original Estimated Enrollment
 (submitted: September 15, 2015)
36
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02552199
Other Study ID Numbers BBI-4000-EM-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Brickell Biotech, Inc.
Study Sponsor Brickell Biotech, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Patricia S Walker, M.D.,Ph.D. Brickell
PRS Account Brickell Biotech, Inc.
Verification Date October 2015