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

Samantha Rodrigues Camargo Neves de Moura

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Oral oxybutynin; Drug: Topical placebo spray; Drug: Topical oxybutynin spray

Study type: Interventional

Funder types: Other

Identifiers

NCT05102396

TODAY Trial

Details and patient eligibility

About

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

Full description

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.

Enrollment: 17 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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+)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 3 patient groups, including a placebo group

Topical oxybutynin spray

Experimental group

Description:

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.

Treatment:

Drug: Topical oxybutynin spray

Topical placebo spray

Placebo Comparator group

Description:

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.

Treatment:

Drug: Topical placebo spray

Oral oxybutynin

Active Comparator group

Description:

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.

Treatment:

Drug: Oral oxybutynin