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

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.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Oxybutynin Sweat Gland Diseases Skin Diseases Autonomic Agents Cholinergic Antagonists Parasympatholytics Drug: Topical oxybutynin spray Drug: Topical placebo spray Drug: Oral oxybutynin Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: Local or Systemic Effect? The TODAY Trial
Actual Study Start Date : September 26, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Topical oxybutynin spray
Participants will receive topical oxybutynin spray (10%).

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.
Drug: Topical placebo spray
Participants will receive 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.
Drug: Oral oxybutynin
Participants will receive oxybutynin (tablets).




Primary Outcome Measures :
  1. 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.

  2. 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".


Secondary Outcome Measures :
  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. [ Time Frame: Baseline and Day 35 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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+)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05102396


Contacts
Layout table for location contacts
Contact: Samantha Moura, MD +55 11 5536-0109 samanthaneves74@gmail.com
Contact: Leandro Agati, PhD +55 11 4040-8670 agati@svriglobal.com

Locations
Layout table for location information
Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo Recruiting
São Paulo, SP, Brazil, 01.223-001
Sponsors and Collaborators
Samantha Rodrigues Camargo Neves de Moura
Science Valley Research Institute
Investigators
Layout table for investigator information
Study Chair: Eduardo Ramacciotti, MD, PhD Science Valley Research Institute
Publications:
Layout table for additonal information
Responsible Party: Samantha Rodrigues Camargo Neves de Moura, Samantha Rodrigues Camargo Neves de Moura - Santa Casa de Sao Paulo School of Medical Sciences, Science Valley Research Institute
ClinicalTrials.gov Identifier: NCT05102396    
Other Study ID Numbers: TODAY Trial
First Posted: November 1, 2021    Key Record Dates
Last Update Posted: May 28, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Red Cap open file.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samantha Rodrigues Camargo Neves de Moura, Science Valley Research Institute:
hyperhidrosis
oxybutynin
anticholinergic
axillary hyperhidrosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Diseases
Hyperhidrosis
Sweat Gland Diseases
Mandelic Acids
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents