HyperhidrosisNCT02633371
A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults
A study testing Oxybutynin 3% gel in people with Hyperhidrosis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a single-center, prospective, open-label, outpatient pilot study evaluating the efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- Oxybutynin 3% gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital, Colorado
Aurora, Colorado, 80045
About this study
This is a single-center, prospective, open-label, outpatient pilot study evaluating the efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.
Read the 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.
- Conditions
- Hyperhidrosis
- Being tested
- Oxybutynin 3% gel
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutynin 3% gelDrug
Also called Gelnique
| Study group | Role | What they receive |
|---|---|---|
| Oxybutynin | Experimental | Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks Receives: Drug: Oxybutynin 3% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Pediatric Dermatology
- Responsible party
- Sponsor
- Investigators
- Anna L Bruckner, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633371
- Sponsor's protocol ID
- 15-0847
- Other IDs
- UL1TR001082
- Status last verified
- May 2018
- First submitted
- 15 Dec 2015
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT02633371
- Acronym / sponsor ID
- 15-0847
- Conditions
- Hyperhidrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Society for Pediatric Dermatology
- Study start
- Feb 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Posted 19 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, prospective, open-label, outpatient pilot study evaluating the efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxybutynin | Experimental | Drug: Oxybutynin 3% gelOxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxybutynin 3% gelAlso: Gelnique | Drug | Oxybutynin |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna L Bruckner, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxybutynin 3% gel in people with Hyperhidrosis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.