Topical Oxybutynin for Treatment of Hyperidrosis: a Local or a Systemic Effect?

Study Overview
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Brief Summary
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The TODAY trial is a study to evaluate the efficacy and safety of topical oxybutynin deodorant for use in patients with axillary hyperhidrosis.

Detailed Description
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Background: Excessive sweating in patients with hyperhidrosis interferes with their quality of life and daily activities. Oral and topical treatments with anticholinergics are a promising strategy for medical management of axillary hyperhidrosis avoiding surgery. Purpose: This study aims to elucidate the efficacy and tolerability of topical oxybutynin deodorant compared with topical placebo and oral oxybutynin in patients with axillary hyperhidrosis. Methods: This is a single-center, prospective, open-label, randomized, and controlled study. Sixty patients with primary focal hyperhidrosis will be recruited and randomized in a 1:1:1 ratio to receive for 42 days either oxybutynin (10%) or placebo spray in a dose of 2 puffs in each armpit twice a day or oral oxybutynin (2.5 mg of oxybutynin once a day in the evening; from the 8th to the 14th day, they will receive 2.5 mg twice a day; and from the 15th day to the end of the 42nd day of treatment, they will receive 5 mg twice a day). The primary endpoint is composed of improvement in hyperhidrosis severity as measured by the Hyperhidrosis Disease Severity Scale (HDSS) and occurrence of adverse events and skin reactions following treatment. The secondary endpoint is composed of improvement in the Quality-of-Life Questionnaire (QoL) and plasma concentrations of oxybutynin following treatment determined by LC-MS/MS. Study visits will occur on Day 1 and Day 42.

Official Title
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Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: a Local or a Systemic Effect? The TODAY Trial

Conditions
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Cholinergic Antagonists, Parasympatholytics, Hyperhidrosis, Oxybutynin, Sweat Gland Diseases, Skin Diseases, Autonomic Agents

Intervention / Treatment
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* Drug: Topical oxybutynin spray
* Drug: Topical placebo spray
* Drug: Oral oxybutynin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a clinical diagnosis of axillary hyperhidrosis. Patients aged between 18 and 45 years old. Patients who are not being treated with another drug or treatment methodology for the disease. Patients who sign the consent form. Exclusion Criteria: Patients who are hypersensitive to oxybutynin hydrochloride. Patients diagnosed with glaucoma, total and partial obstruction of the intestinal tract, ulcerative colitis, megacolon and myasthenia gravis and cardiac diseases. Patients who are pregnant or intend to become pregnant. Patients who have previous indications for treatment with OX.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical oxybutynin spray<br>Participants with axillary hyperhidrosis will receive topical oxybutynin spray (10%) in an appropriate dose of 2 puffs in each armpit twice a day for 42 days. | Drug: Topical oxybutynin spray<br>* Participants will receive topical oxybutynin spray (10%).<br>|
| Placebo Comparator: Topical placebo spray<br>Participants with axillary hyperhidrosis will receive topical placebo spray in an appropriate dose of 2 puffs in each armpit twice a day for 42 days. | Drug: Topical placebo spray<br>* Participants will receive topical placebo spray.<br>|
| Active Comparator: Oral oxybutynin<br>Participants with axillary hyperhidrosis will receive oral oxybutynin for 42 days as follows: during the first week, participants will receive 2.5 mg of oxybutynin once a day in the evening; from the 8th to the 14th day, they will receive 2.5 mg twice a day; and from the 15th day to the end of the 42nd day of treatment, they will receive 5 mg twice a day. | Drug: Oral oxybutynin<br>* Participants will receive oxybutynin (tablets).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline | A treatment responder is defined as any participant with a change in the HDSS score from a baseline score of 3 or 4 to a score of 1 or 2 at Day 42. The HDSS is a patient completed validated scale that provides a qualitative measure of the severity of hyperhidrosis participants' condition based on how it affects their daily activities. It is a 4-point scale with scores defined as follows: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities). A score of 1 or 2 indicates mild or moderate hyperhidrosis. A score of 3 or 4 indicates severe hyperhidrosis. | Baseline and Day 42 | 
| Percentage of participants who develop serious adverse events and adverse events considered as definitely or probably associated with treatment |  | From randomization to end of study at Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in quality-of-life (QOL) questionnaire | Mean improvement in QoL (Based on a 5 point scale with 0=no improvement and 5=extreme improvement). The difference between the final answer at the end of treatment at Day 42 and the one registered at baseline is called the effect of treatment in the QOL. Quality of life questionnaire by De Campos et al. (2003) contains 20 items divided between the five domains functional, social, personal, emotional, and special condition. The special condition domain covered various aspects such as tenseness, public speaking, shoe wear, clothing, and problems at school. The response options to each item ranged from one to five points, which equaled excellent to very poor. The overall score can be calculated by summing the points of all items. | Baseline and Day 42 | 
| Plasma concentrations of oxybutynin following oral and topic treatment determined by LC-MS/MS | Mean plasma concentration of oxybutynin in samples collected at Day 1 (baseline, predose) and at Day 42 (postdose). | Baseline and Day 42 |