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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-26

Study Completion Date

2024-08-30

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.

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Detailed Description

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Background: Anticholinergics, both orally and topically, have been shown to enhance quality of life and reduce sweat in patients with hyperhidrosis, potentially obviating the need for surgical interventions. However, it remains unclear whether topical application specifically exerts local or systemic effects in patients with axillary hyperhidrosis. This study's primary aim is to assess topical oxybutynin's impact on axillary hyperhidrosis.

Study Design: Twenty patients (initially planned sample size) diagnosed with axillary hyperhidrosis will be randomized into three groups. Group A will receive 2.5 mg of oral oxybutynin once daily at night for the first seven days, 2.5 mg twice daily from the 8th to the 21st day, and 5 mg twice daily from the 22nd to the 35th day. Group B will be administered a topical placebo as an oxybutynin spray, applying two sprays to each axilla twice daily for 35 days. Group C will receive a 10% oxybutynin topical spray, also used with two sprays to each axilla twice daily over 35 days (investigational product). The primary efficacy outcome will be the evaluation of the effectiveness of topical oxybutynin spray in treating hyperhidrosis, assessed by the number of patients showing an improvement in the severity of their condition by day 35, as measured by the Hyperhidrosis Disease Severity Scale (HDSS). Safety will be assessed by adverse and severe adverse events during the treatment

Summary: The TODAY trial will generate high-quality evidence on the effects of topical oxybutynin, assessing whether its impact is local or systemic in patients with axillary hyperhidrosis.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical oxybutynin spray

Participants with axillary hyperhidrosis will receive topical oxybutynin spray (10%) in an appropriate dose of 2 puffs in each armpit twice a day for 35 days.

Group Type EXPERIMENTAL

Topical oxybutynin spray

Intervention Type DRUG

Participants will receive topical oxybutynin spray (10%).

Topical placebo spray

Participants with axillary hyperhidrosis will receive topical placebo spray in an appropriate dose of 2 puffs in each armpit twice a day for 35 days.

Group Type PLACEBO_COMPARATOR

Topical placebo spray

Intervention Type DRUG

Participants will receive topical placebo spray.

Oral oxybutynin

Participants with axillary hyperhidrosis will receive oral oxybutynin for 35 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 35th day of treatment, they will receive 5 mg twice a day.

Group Type ACTIVE_COMPARATOR

Oral oxybutynin

Intervention Type DRUG

Participants will receive oxybutynin (tablets).

Interventions

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Topical oxybutynin spray

Participants will receive topical oxybutynin spray (10%).

Intervention Type DRUG

Topical placebo spray

Participants will receive topical placebo spray.

Intervention Type DRUG

Oral oxybutynin

Participants will receive oxybutynin (tablets).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients aged ≥18 years and ≤ 45 years
* Not treated patient with another drug or treatment methodology for the disease for at least 30 days

Exclusion Criteria

* Patients who are hypersensitive to oxybutynin hydrochloride.
* Not treated patient with another drug or treatment methodology for the disease for at least 30 days
* Patients who have menopausal symptoms
* Patients who show signs of skin lesions in the armpit
* Pregnancy. Women with the potential to bear children should be under contraceptive strategies and take a negative pregnancy test to be enrolled
* Patients with COVID in the contagious phase (PCR+)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No