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

Skin Diseases Clinical Trial

— TODAY  

Official title:

Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: Local or Systemic Effect? The TODAY Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05102396
• Other study ID #: TODAY Trial
• Status: Recruiting
• Phase: Phase 2
• Start date: September 26, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: May 2024
• Source: Science Valley Research Institute
• Contact: Samantha Moura, MD
• Phone: +55 11 5536-0109
• Email: samanthaneves74[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The TODAY trial is a study to evaluate the efficacy and safety of topical oxybutynin deodorant for use in patients with axillary hyperhidrosis.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: August 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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+)

Related Conditions & MeSH terms

• Cholinergic Antagonists
• Hyperhidrosis
• Skin Diseases
• Sweat Gland Diseases

Intervention

Drug:
• Topical oxybutynin spray
Participants will receive topical oxybutynin spray (10%).
• Topical placebo spray
Participants will receive topical placebo spray.
• Oral oxybutynin
Participants will receive oxybutynin (tablets).

Locations

Country	Name	City	State
Brazil	Irmandade da Santa Casa de Misericórdia de São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Samantha Rodrigues Camargo Neves de Moura	Science Valley Research Institute

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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