Treatment of primary hyperhidrosis through a comparative study between oxybutynin hydrochloride and placebo. Hydrochloride may decrease the symptoms of hyperhidrosis improving the subject's quality of life.
Clinical Trial phase III, randomized, national, prospective, double-blind, multicenter, comparative between oxybutynin hydrochloride and placebo, to be held in participants aged over 18 years to evaluate the therapeutic efficacy and safety of oxybutynin chloride to systemic treatment of primary hyperhidrosis. Primary hyperhidrosis is a relatively common disorder, affecting approximately 3% of the population. It affects both sexes similarly and in all age groups, varying only the starting age of symptoms according to the most affected part of the body: childhood - plantar and palmar hyperhidrosis adolescence - axillary hyperhidrosis adult - craniofacial hyperhidrosis There is a family history associated with between 12.5% and 56.5% of the participants, according to epidemiological studies. Initially the subjects will be evaluated on the inclusion and exclusion criteria through screening and safety tests such as blood tests , ECG and tonometry, to confirm enrollment. When included will be randomized into the corresponding study arm to start study treatment. During the period of the study it will evaluate the efficacy parameters of the drug. The treatment for each subject will be about 8 weeks. The inclusion period is foreseen for 6 months and may be extended or decreased according to the pace of inclusion. The data are summarized according to the study group (per dose and per visit, if applicable) through appropriate descriptive statistics to the variable type. Frequency and percentage will be used for the variables. The Adverse Events (AE) will be analyzed based on questioning by the investigators in relation to the AE experienced by the subjects. The orientation will be to the subject to note the symptom, the date and time that the event appeared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
The doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits.
The quantity of tablets will increase due to the absence/ lack of therapeutic response.
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Oxybutynin Chloride efficacy
Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.
Time frame: 6 weeks
Perception of improvement
Evaluation of perception of improvement from the subject by completing a questionaire
Time frame: During treatment until week 8
Evaluate therapeutic safety
Evaluate therapeutic safety of the Oxybutynin Chloride by assessing possible adverse event
Time frame: During treatment until week 8
Quality of life
Evaluate the difference in subject's quality of life between the treatment groups
Time frame: During treatment until week 8
Time of subject response
Evaluation of average time the subject reaches response
Time frame: End of 8 weeks
Duration of response
Evaluate the duration of response
Time frame: End of 8 weeks
Evaluation between quality of life and groups
Evaluate the difference of quality of life in the end of treatment between the groups
Time frame: End of 8 weeks
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