The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05102396
Recruitment Status : Recruiting
First Posted : November 1, 2021
Last Update Posted : May 28, 2024
Sponsor:
Collaborator:
Science Valley Research Institute
Information provided by (Responsible Party):
Samantha Rodrigues Camargo Neves de Moura, Science Valley Research Institute

Tracking Information
First Submitted Date  ICMJE October 14, 2021
First Posted Date  ICMJE November 1, 2021
Last Update Posted Date May 28, 2024
Actual Study Start Date  ICMJE September 26, 2022
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2024)
  • Improvement in hyperhidrosis severity by day 35, as measured by the Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: Baseline and Day 35 ]
    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.
  • Quality of life (QoL) assessment using the improvement metrics from a quality-of-life questionnaire published in 2003: de Campos JR et al. [ Time Frame: From randomization to end of study at Day 35 ]
    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".
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2021)
  • Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline [ Time Frame: Baseline and Day 42 ]
    A treatment responder is defined as any participant with a change in the HDSS score from a baseline score of 3 or 4 to a score of 1 or 2 at Day 42. 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.
  • Percentage of participants who develop serious adverse events and adverse events considered as definitely or probably associated with treatment [ Time Frame: From randomization to end of study at Day 42 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2024)
Clinical evaluation of adverse and severe adverse events was recorded as the number of participants experiencing adverse events, including dry mouth and cutaneous lesions. [ Time Frame: Baseline and Day 35 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2021)
  • Mean change in quality-of-life (QOL) questionnaire [ Time Frame: Baseline and Day 42 ]
    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 42 and the one registered at baseline is called "the effect of treatment in the QOL". Quality of life questionnaire by De Campos et al. (2003) contains 20 items divided between the five domains functional, social, personal, emotional, and special condition. The special condition domain covered various aspects such as tenseness, public speaking, shoe wear, clothing, and problems at school. The response options to each item ranged from one to five points, which equaled excellent to very poor. The overall score can be calculated by summing the points of all items.
  • Plasma concentrations of oxybutynin following oral and topic treatment determined by LC-MS/MS [ Time Frame: Baseline and Day 42 ]
    Mean plasma concentration of oxybutynin in samples collected at Day 1 (baseline, predose) and at Day 42 (postdose).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Oxybutynin for Treatment of Hyperidrosis: Local or Systemic Effect?
Official Title  ICMJE Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: Local or Systemic Effect? The TODAY Trial
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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperhidrosis
  • Oxybutynin
  • Sweat Gland Diseases
  • Skin Diseases
  • Autonomic Agents
  • Cholinergic Antagonists
  • Parasympatholytics
Intervention  ICMJE
  • Drug: Topical oxybutynin spray
    Participants will receive topical oxybutynin spray (10%).
  • Drug: Topical placebo spray
    Participants will receive topical placebo spray.
  • Drug: Oral oxybutynin
    Participants will receive oxybutynin (tablets).
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Topical oxybutynin spray
  • 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.
    Intervention: Drug: Topical placebo spray
  • 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.
    Intervention: Drug: Oral oxybutynin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2024)
17
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2021)
60
Estimated Study Completion Date  ICMJE August 30, 2024
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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+)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Samantha Moura, MD +55 11 5536-0109 samanthaneves74@gmail.com
Contact: Leandro Agati, PhD +55 11 4040-8670 agati@svriglobal.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05102396
Other Study ID Numbers  ICMJE TODAY Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Red Cap open file.
Current Responsible Party Samantha Rodrigues Camargo Neves de Moura, Science Valley Research Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Samantha Rodrigues Camargo Neves de Moura
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Science Valley Research Institute
Investigators  ICMJE
Study Chair: Eduardo Ramacciotti, MD, PhD Science Valley Research Institute
PRS Account Science Valley Research Institute
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP