Topical oxybutynin for treating excessive sweating
Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: Local or Systemic Effect? The TODAY Trial
This study is testing a new skin spray with oxybutynin to see if it can help people with excessive underarm sweating feel drier compared to a pill or a fake spray.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Science Valley Research Institute Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT05102396 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the efficacy and safety of a topical oxybutynin spray for patients suffering from axillary hyperhidrosis. It involves a randomized design with three groups: one receiving oral oxybutynin, another receiving a topical placebo, and the last receiving the investigational topical oxybutynin. The primary goal is to determine the effectiveness of the topical treatment in reducing sweat severity, measured by the Hyperhidrosis Disease Severity Scale over 35 days. Safety will also be monitored through adverse event reporting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 45 diagnosed with axillary hyperhidrosis who have not received other treatments for at least 30 days.
Not a fit: Patients with hypersensitivity to oxybutynin, skin lesions in the armpit, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for patients with excessive sweating, improving their quality of life.
How similar studies have performed: While anticholinergics have been used in various forms for hyperhidrosis, the specific use of topical oxybutynin is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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+)
Where this trial is running
São Paulo, São Paulo
- Irmandade da Santa Casa de Misericórdia de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Samantha Moura, MD
- Email: samanthaneves74@gmail.com
- Phone: +55 11 5536-0109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.