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

• ClinicalTrials.gov Identifier: NCT05102396
• Recruitment Status: Unknown
• First Posted: November 1, 2021
• Last Update Posted: November 1, 2021
• Sponsor: Samantha Rodrigues Camargo Neves de Moura
• 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: October 14, 2021
• First Posted Date: November 1, 2021
• Last Update Posted Date: November 1, 2021
• Estimated Study Start Date: October 2021
• Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 ]

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Topical Oxybutynin for Treatment of Hyperidrosis: a Local or a Systemic Effect?
• Official Title: Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: a Local or a 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: Excessive sweating in patients with hyperhidrosis interferes with their quality of life and daily activities. Oral and topical treatments with anticholinergics are a promising strategy for medical management of axillary hyperhidrosis avoiding surgery.

Purpose: This study aims to elucidate the efficacy and tolerability of topical oxybutynin deodorant compared with topical placebo and oral oxybutynin in patients with axillary hyperhidrosis.

Methods: This is a single-center, prospective, open-label, randomized, and controlled study. Sixty patients with primary focal hyperhidrosis will be recruited and randomized in a 1:1:1 ratio to receive for 42 days either oxybutynin (10%) or placebo spray in a dose of 2 puffs in each armpit twice a day or oral oxybutynin (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 42nd day of treatment, they will receive 5 mg twice a day). The primary endpoint is composed of improvement in hyperhidrosis severity as measured by the Hyperhidrosis Disease Severity Scale (HDSS) and occurrence of adverse events and skin reactions following treatment. The secondary endpoint is composed of improvement in the Quality-of-Life Questionnaire (QoL) and plasma concentrations of oxybutynin following treatment determined by LC-MS/MS. Study visits will occur on Day 1 and Day 42.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hyperhidrosis
• Oxybutynin
• Sweat Gland Diseases
• Skin Diseases
• Autonomic Agents
• Cholinergic Antagonists
• Parasympatholytics

Intervention

• 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

• 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 42 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 42 days.
  Intervention: Drug: Topical placebo spray
• Active Comparator: Oral oxybutynin
  Participants with axillary hyperhidrosis will receive oral oxybutynin for 42 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 42nd day of treatment, they will receive 5 mg twice a day.
  Intervention: Drug: Oral oxybutynin

Publications *

• 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.
• Sharma 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 27, 2021): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2022
• Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients with a clinical diagnosis of axillary hyperhidrosis.
• Patients aged between 18 and 45 years old.
• Patients who are not being treated with another drug or treatment methodology for the disease.
• Patients who sign the consent form.

Exclusion Criteria:

• Patients who are hypersensitive to oxybutynin hydrochloride.
• Patients diagnosed with glaucoma, total and partial obstruction of the intestinal tract, ulcerative colitis, megacolon and myasthenia gravis and cardiac diseases.
• Patients who are pregnant or intend to become pregnant.
• Patients who have previous indications for treatment with OX.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT05102396
• Other Study ID Numbers: 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

• 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: Samantha Rodrigues Camargo Neves de Moura
• Original Study Sponsor: Same as current
• Collaborators: Science Valley Research Institute

Investigators

• Study Chair: Eduardo Ramacciotti, MD, PhD; Science Valley Research Institute

• PRS Account: Science Valley Research Institute
• Verification Date: October 2021