Topical Oxybutynin for Treatment of Hyperidrosis: a Local or a 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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05102396 |
|
Recruitment Status : Unknown
Verified October 2021 by Samantha Rodrigues Camargo Neves de Moura, Science Valley Research Institute.
Recruitment status was: Not yet recruiting
First Posted : November 1, 2021
Last Update Posted : November 1, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| 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 |
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 (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: a Local or a Systemic Effect? The TODAY Trial |
| Estimated Study Start Date : | October 2021 |
| Estimated Primary Completion Date : | March 2022 |
| Estimated Study Completion Date : | June 2022 |
| 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 42 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 42 days.
|
Drug: Topical placebo spray
Participants will receive 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.
|
Drug: Oral oxybutynin
Participants will receive oxybutynin (tablets). |
- 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 ]
- 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).
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.
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| Contact: Samantha Moura, MD | +55 11 5536-0109 | samanthaneves74@gmail.com | |
| Contact: Leandro Agati, PhD | +55 11 4040-8670 | agati@svriglobal.com |
| Brazil | |
| Irmandade da Santa Casa de Misericórdia de São Paulo | |
| São Paulo, SP, Brazil, 01.223-001 | |
| Study Chair: | Eduardo Ramacciotti, MD, PhD | Science Valley Research Institute |
| 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: | November 1, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Red Cap open file. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
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 |