Clinical trial NCT05102396: Topical Oxybutynin for Treatment of Hyperidrosis: Local or Systemic Effect?
Official title: Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: Local or Systemic Effect? The TODAY Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hyperhidrosis
Oxybutynin
Sweat Gland Diseases
Skin Diseases
Autonomic Agents
Cholinergic Antagonists
Parasympatholytics
Keywords: hyperhidrosis
oxybutynin
anticholinergic
axillary hyperhidrosis
Lead sponsor: Science Valley Research Institute
Sponsor class: OTHER
Collaborators: name: Science Valley Research Institute
First posted: 2021-11-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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+)

Primary outcomes:
measure: Improvement in hyperhidrosis severity by day 35, as measured by the Hyperhidrosis Disease Severity Scale (HDSS)
timeFrame: Baseline and Day 35
measure: Quality of life (QoL) assessment using the improvement metrics from a quality-of-life questionnaire published in 2003: de Campos JR et al.
timeFrame: From randomization to end of study at Day 35
Secondary outcomes:
measure: Clinical evaluation of adverse and severe adverse events was recorded as the number of participants experiencing adverse events, including dry mouth and cutaneous lesions.
timeFrame: Baseline and Day 35
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de São Paulo
state: SP
Study officials:
affiliation: Science Valley Research Institute
name: Eduardo Ramacciotti, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
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.