Axillary hyperhidrosis
Conditions
Interventions
Test group:Botulinum toxin A (50 U in one axilla, 100 U in both axilla) was injected intradermal.
Control group:Botulinum toxin A placebo, intradermal injection.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-65,no gender requirement; (2) The diagnostic criteria for primary axillary hyperhidrosis were met, and the Hyperhidrosis Disease Severity Scale (HDSS) score was 3 or 4; (3) Patients whose weight of sweat in the bilateral axilla measured by weight was 50 mg or heavier , after resting for 5 min at room temperature; (4) Informed consent for this trial and the voluntary signing of a written informed consent form will enable good communication with the investigator and compliance with the requirements of the clinical trial.
Exclusion criteria
Exclusion criteria: (1) Patients who are allergics or People who are allergic to research drugs and any component, iodine (2) Patients with myasthenia gravis, Lambrt-Eaton syndrome, motor neuropathy, muscular amyotrophic lateral sclerosis, or any disease that may interfere with neuromuscular function (3) Patients with secondary hyperhidrosis(e. g. secondary to underlying hyperthyroidism, lymphoma, etc.) (4) Patients with complicated urinary tract infections, urinary retention, major systemic disease, patients with acute infectious diseases or at risk of angle closure glaucoma and patients with anatomically narrow atrial angles (5) Patients with an infection at the injection site, or any other skin problems, or a history of keloid formation (6) Patients with a previous history of epilepsy, or mild seizures, or severe cognitive impairment or mental illness affecting test execution (7) Patients who had undergone any surgery in the axillary region or had ever undergone radical surgery to remove the sweat glands within 3 months before screening (8) Patients scheduled for laser hair removal in the axillary area within 3 months before screening or during the study (9) Patients who have received any botulinum toxin preparation within 6 months prior to the screening, or who are expected to use any botulinum toxin preparation other than the test drug during the study period (10) Within 14 days before screening, Patients had used anticholinergic drugs, anticoagulation agents, antiplatelet drugs, aminoglycoside antimicrobials (such as gentamicin), choline lipase antagonists, succinylcholine, cylinder venom base, magnesium sulfate, quinidine, calcium ion channel blockers, linclinamide drugs, polymyxin, or other drugs that may interfere with neuromuscular function (11) Patients who had used any antiperspirant / deodorant products within 48 h before the randomization (12) Patients with any positive or active hepatitis B antibodies for human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, and hepatitis C virus (HCV) antibody (13) Persons with a previous history of alcohol abuse, substance abuse, or presence of drug dependence (14) Women during pregnancy or lactation, or female subjects with unprotected sex in the last two weeks, or female subjects with a positive blood pregnancy test; subjects with birth planning or sperm / egg donors (or their partners) throughout the trial and within 6 months after the study, and patients who are reluctant to take one or more contraception during the trial and within 6 months after the end of the study (15) Patients who had received any other trial medication or had participated in another interventional clinical trial within 3 months before the screening visit (16) The investigator believes that there is any situation that may affect the subject to provide informed consent or follow the trial protocol, or that the subject's participation in the trial may affect the trial results or their own safe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of the portion of subjects whose axillary sweating weight decreased 50% or more from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in axillary sweat weight (gravimetric method) from baseline at weeks 1, 4, 8, and 16 post-treatment;Duration of >50% reduction in axillary sweat weight from baseline;Subject satisfaction scores at weeks 1, 4, 8, and 16 post-treatment?;Proportion of subjects with =2-grade improvement in Hyperhidrosis Disease Severity Scale (HDSS) score from baseline at weeks 1, 4, 8, and 16 post-treatment;Changes in sweat area size assessed by iodine-starch test photographs from baseline at weeks 4, 8, and 16 post-treatment?;Cure rate and overall response rate of axillary bromhidrosis grading at weeks 1, 4, 8, and 16 post-treatment (evaluated only in subjects with baseline grade 2 or 3)??; | — |
Countries
China
Contacts
Public ContactLi Li
West China Hospital, Sichuan University
Outcome results
None listed