NCT02633371

Brief Summary

This is a single-center, prospective, open-label, outpatient pilot study evaluating the efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 19, 2018

Completed
Last Updated

June 19, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

December 15, 2015

Results QC Date

March 12, 2018

Last Update Submit

May 18, 2018

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Improvement in Hyperhidrosis Severity at Week 1 or Week 4 as Measured by the Hyperhidrosis Disease Severity Scale (HDSS).

    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.

    Week 1 and week 4

Study Arms (1)

Oxybutynin

EXPERIMENTAL

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

Drug: Oxybutynin 3% gel

Interventions

Oxybutynin 3% gelDRUG
Also known as: Gelnique
Oxybutynin

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Eligible subjects must be 12-25 years old and meet consensus criteria for primary focal hyperhidrosis: focal, visible, excessive sweating of at least 6 months duration without apparent cause with at least two of the following characteristics: 1) Bilateral and relatively symmetric, 2) Impairs daily activities, 3) Frequency of at least one episode per week, 4) Age of onset less than 25 years, 5) Positive family history, 6) Cessation of focal sweating during sleep.
  • Eligible subjects must have moderate to severe hyperhidrosis which correlates to a score of 3 or 4 on the HDSS.
  • Hyperhidrosis must affect the bilateral axilla; however, patients with concurrent focal hyperhidrosis affecting the palms, soles, face, or other area will not be excluded.
  • Subjects must be willing to comply with the study protocol.

You may not qualify if:

  • Subjects with hyperhidrosis of less than 6 months duration or hyperhidrosis secondary to an underlying infectious, endocrine, or neurologic disorder.
  • Treatment with botulinum toxin injections to the axillae or other affected areas within the last 12 weeks OR treatment with other agents (oral anticholinergic medications, topical aluminum chloride) in the last 4 weeks.
  • Subjects with active skin inflammation or infection affecting the axilla
  • Subjects who report history of closed-angle glaucoma, urinary retention, decreased gastrointestinal motility, hiatal hernia, cardiac arrhythmia, coronary artery disease, congestive health failure, hyperthyroidism, myasthenia gravis, xerostomia, renal insufficiency, or hepatic impairment.
  • Subjects with hypertension defined as systolic blood pressure \> 140 or diastolic blood pressure \> 90 on more than 1 occasion separated by 1 week.
  • Subjects with the following: history of somnolence, confusion, hallucinations OR subjects taking other medications that may cause somnolence, confusion, hallucinations OR subjects with other medical conditions that may predispose them for somnolence, confusion, or hallucinations.
  • Subjects who have demonstrated hypersensitivity to the drug substance or other components of the product
  • Subjects taking drugs which inhibit Cytochrome P450 3A4 (CYP3A4)
  • Pregnant and/or nursing females
  • Any other disease that would interfere with the study or place them at undue risk or who are in any way unable to comply with study requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital, Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

oxybutyninGels

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Anna Bruckner
Organization
University of Colorado
anna.bruckner@ucdenver.edu
720-777-0955

Study Officials

  • Anna L Bruckner, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 17, 2015

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

May 1, 2017

Last Updated

June 19, 2018

Results First Posted

June 19, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)