Trial Outcomes & Findings for A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults (NCT NCT02633371)
NCT ID: NCT02633371
Last Updated: 2018-06-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Week 1 and week 4
Results posted on
2018-06-19
Participant Flow
Participant milestones
| Measure |
Oxybutynin
Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults
Baseline characteristics by cohort
| Measure |
Oxybutynin
n=10 Participants
Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
|
|---|---|
|
Age, Continuous
|
18.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Week 1 and week 4A 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.
Outcome measures
| Measure |
Oxybutynin
n=7 Participants
Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
|
|---|---|
|
Number of Patients With Improvement in Hyperhidrosis Severity at Week 1 or Week 4 as Measured by the Hyperhidrosis Disease Severity Scale (HDSS).
|
4 participants
|
Adverse Events
Oxybutynin
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxybutynin
n=10 participants at risk
Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
Oxybutynin 3% gel
|
|---|---|
|
Renal and urinary disorders
Pyelonephritis
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
Oxybutynin
n=10 participants at risk
Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
Oxybutynin 3% gel
|
|---|---|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Blurry vision
|
10.0%
1/10 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place