Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: Local or Systemic Effect? The TODAY Trial
Who is this study for? Patients with axillary hyperhidrosis
What treatments are being studied? Oxybutynin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The TODAY trial is a study to evaluate the efficacy and safety of topical oxybutynin deodorant for use in patients with axillary hyperhidrosis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:
• Patients aged ≥18 years and ≤ 45 years
• Not treated patient with another drug or treatment methodology for the disease for at least 30 days
Locations
Other Locations
Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Samantha Moura, MD
samanthaneves74@gmail.com
+55 11 5536-0109
Backup
Leandro Agati, PhD
agati@svriglobal.com
+55 11 4040-8670
Time Frame
Start Date: 2022-09-26
Estimated Completion Date: 2024-08-30
Participants
Target number of participants: 17
Treatments
Experimental: 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.
Placebo_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Science Valley Research Institute
Leads: Samantha Rodrigues Camargo Neves de Moura