A Phase 2 interventional study of Topical oxybutynin spray and Topical placebo spray in Hyperhidrosis, Oxybutynin and Sweat Gland Diseases, sponsored by Samantha Rodrigues Camargo Neves de Moura. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Samantha Rodrigues Camargo Neves de Moura · Phase 2, Interventional, and Treatment
The TODAY trial is a study to evaluate the efficacy and safety of topical oxybutynin deodorant for use in patients with axillary hyperhidrosis.
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.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's planned enrollment of 17 is below the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →This is the only study on the registry with Samantha Rodrigues Camargo Neves de Moura as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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 topical oxybutynin spray (10%).
Participants will receive topical placebo spray.
Participants will receive oxybutynin (tablets).
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.
Time frame: Baseline and Day 35
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".
Time frame: From randomization to end of study at Day 35
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
Plan to share: Undecided — Red Cap open file.
Started Sep 2022 (actual). Primary completion is estimated for Jun 2024, 21 months after the start.
Of 14 phase 2 interventional studies under Hyperhidrosis, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 11. This study's planned 21 months is above that.
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Studies of the drug tested here: Oxybutynin