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Trial record 35 of 166 for:    "Sweat Gland Disease"

A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults

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: NCT02633371
Recruitment Status : Completed
First Posted : December 17, 2015
Results First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
Society for Pediatric Dermatology
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hyperhidrosis
Intervention Drug: Oxybutynin 3% gel
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxybutynin
Hide Arm/Group Description Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
Period Title: Overall Study
Started 10
Completed 7
Not Completed 3
Arm/Group Title Oxybutynin
Hide Arm/Group Description Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
18.5
(13 to 24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
9
  90.0%
Male
1
  10.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
7
  70.0%
Not Hispanic or Latino
3
  30.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
  20.0%
More than one race
1
  10.0%
Unknown or Not Reported
7
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Number of Patients With Improvement in Hyperhidrosis Severity at Week 1 or Week 4 as Measured by the Hyperhidrosis Disease Severity Scale (HDSS).
Hide Description A treatment responder is defined as any participant with a change in the Hyperhidrosis Disease Severity Scale (HDSS) score from a baseline score of 3 or 4 to a score of 1 or 2 at week 1 or week 4.
Time Frame Week 1 and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxybutynin
Hide Arm/Group Description:
Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxybutynin
Hide Arm/Group Description

Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks

Oxybutynin 3% gel

All-Cause Mortality
Oxybutynin
Affected / at Risk (%)
Total   0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Oxybutynin
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Renal and urinary disorders   
Pyelonephritis   1/10 (10.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxybutynin
Affected / at Risk (%) # Events
Total   3/10 (30.00%)    
Eye disorders   
Blurry vision *  1/10 (10.00%)  1
Gastrointestinal disorders   
Dry mouth   2/10 (20.00%)  2
Constipation   1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Anna Bruckner
Organization: University of Colorado
Phone: 720-777-0955
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02633371     History of Changes
Other Study ID Numbers: 15-0847
UL1TR001082 ( U.S. NIH Grant/Contract )
First Submitted: December 15, 2015
First Posted: December 17, 2015
Results First Submitted: March 12, 2018
Results First Posted: June 19, 2018
Last Update Posted: June 19, 2018