Skin Diseases Clinical Trial
— TODAYOfficial title:
Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: a Local or a Systemic Effect? The TODAY Trial
The TODAY trial is a study to evaluate the efficacy and safety of topical oxybutynin deodorant for use in patients with axillary hyperhidrosis.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | June 2022 |
Est. primary completion date | March 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Irmandade da Santa Casa de Misericórdia de São Paulo | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Samantha Rodrigues Camargo Neves de Moura | Science Valley Research Institute |
Brazil,
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. — 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline | 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. |
Baseline and Day 42 | |
Primary | Percentage of participants who develop serious adverse events and adverse events considered as definitely or probably associated with treatment | From randomization to end of study at Day 42 | ||
Secondary | Mean change in quality-of-life (QOL) questionnaire | 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. |
Baseline and Day 42 | |
Secondary | Plasma concentrations of oxybutynin following oral and topic treatment determined by LC-MS/MS | Mean plasma concentration of oxybutynin in samples collected at Day 1 (baseline, predose) and at Day 42 (postdose). | Baseline and Day 42 |
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