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

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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

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

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: Oxybutynin 3% gel Not Applicable

Detailed Description:
This study will determine if daily application of topical oxybutynin 3% gel reduces the symptoms of primary axillary hyperhidrosis in adolescents and young adults. It will also assess the impact of daily topical oxybutynin 3% gel on Health Related Quality of Life (HRQOL); determine if daily topical oxybutynin 3% gel has a treatment effect at distant, untreated sites; and assess the local and systemic tolerability of daily topical oxybutynin 3% gel. Finally, the study will determine the treatment effect size, if one exists, in order to power a larger, placebo-controlled study in the future.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults
Actual Study Start Date : February 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oxybutynin
Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
Drug: Oxybutynin 3% gel
Other Name: Gelnique




Primary Outcome Measures :
  1. Number of Patients With Improvement in Hyperhidrosis Severity at Week 1 or Week 4 as Measured by the Hyperhidrosis Disease Severity Scale (HDSS). [ Time Frame: Week 1 and week 4 ]
    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.



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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT02633371


Locations
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United States, Colorado
Children's Hospital, Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Society for Pediatric Dermatology
Investigators
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Principal Investigator: Anna L Bruckner, MD University of Colorado, Denver

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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 Posted: December 17, 2015    Key Record Dates
Results First Posted: June 19, 2018
Last Update Posted: June 19, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sweat Gland Diseases
Hyperhidrosis
Skin Diseases
Mandelic Acids
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents