Topical Oxybutynin for Treatment of Hyperidrosis: Local or Systemic Effect?
TODAY
Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: Local or Systemic Effect? The TODAY Trial
1 other identifier
interventional
17
1 country
1
Brief Summary
The TODAY trial is a study to evaluate the efficacy and safety of topical oxybutynin deodorant for use in patients with axillary hyperhidrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2021
CompletedFirst Posted
Study publicly available on registry
November 1, 2021
CompletedStudy Start
First participant enrolled
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedMay 28, 2024
May 1, 2024
1.8 years
October 14, 2021
May 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Improvement in hyperhidrosis severity by day 35, as measured by the Hyperhidrosis Disease Severity Scale (HDSS)
A treatment responder defined any participant whose HDSS score initially was 3 or 4 and who achieved at least a 1-point improvement in the scale by day 35.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 35
Quality of life (QoL) assessment using the improvement metrics from a quality-of-life questionnaire published in 2003: de Campos JR et al.
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 35 and the one registered at baseline is called "the effect of treatment in the QOL".
From randomization to end of study at Day 35
Secondary Outcomes (1)
Clinical evaluation of adverse and severe adverse events was recorded as the number of participants experiencing adverse events, including dry mouth and cutaneous lesions.
Baseline and Day 35
Study Arms (3)
Topical oxybutynin spray
EXPERIMENTALParticipants 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.
Topical placebo spray
PLACEBO COMPARATORParticipants with axillary hyperhidrosis will receive topical placebo spray in an appropriate dose of 2 puffs in each armpit twice a day for 35 days.
Oral oxybutynin
ACTIVE COMPARATORParticipants 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.
Interventions
Participants will receive topical oxybutynin spray (10%).
Eligibility Criteria
You may qualify if:
- Patients aged ≥18 years and ≤ 45 years
- Not treated patient with another drug or treatment methodology for the disease for at least 30 days
You may not qualify if:
- 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+)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, 01.223-001, Brazil
Related Publications (2)
de Campos JR, Kauffman P, Werebe Ede C, Andrade Filho LO, Kusniek S, Wolosker N, Jatene FB. Quality of life, before and after thoracic sympathectomy: report on 378 operated patients. Ann Thorac Surg. 2003 Sep;76(3):886-91. doi: 10.1016/s0003-4975(03)00895-6.
PMID: 12963223BACKGROUNDSharma P, Patel DP, Sanyal M, Berawala H, Guttikar S, Shrivastav PS. Simultaneous analysis of oxybutynin and its active metabolite N-desethyl oxybutynin in human plasma by stable isotope dilution LC-MS/MS to support a bioequivalence study. J Pharm Biomed Anal. 2013 Oct;84:244-55. doi: 10.1016/j.jpba.2013.06.024. Epub 2013 Jun 28.
PMID: 23867086BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eduardo Ramacciotti, MD, PhD
Science Valley Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Samantha Rodrigues Camargo Neves de Moura - Santa Casa de Sao Paulo School of Medical Sciences
Study Record Dates
First Submitted
October 14, 2021
First Posted
November 1, 2021
Study Start
September 26, 2022
Primary Completion
June 30, 2024
Study Completion
August 30, 2024
Last Updated
May 28, 2024
Record last verified: 2024-05