GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis

Inclusion Criteria

• At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.)
• Patients with primary axillary hyperhidrosis whose excessive sweating in each axillae interferes daily life activities and whose Hyperhidrosis Disease Severity Scale (HDSS) score is 3 or 4.
• Age of 20 to 75 years at the time of informed consent.
• Both genders are eligible to enrol in the study. For men, only those who can practice contraception during the study period are eligible. Women of childbearing potential may be enrolled only if they have negative pregnancy test both in the screening period and just before treatment. Women of childbearing potential must agree to use one or more of the following reliable contraceptive measures throughout the study period:

*: Abstinence, oral contraceptives, progesterone injection, levonorgestrel implant, estrogen ring, transdermal contraceptives, intrauterine device, vasectomized partner, and double-barrier contraception (condom or diaphragm with spermicidal jelly/film).

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• At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.)
• Patients with primary axillary hyperhidrosis whose excessive sweating in each axillae interferes daily life activities and whose HDSS score is 3 or 4.
• Asparate aminotransferase (AST) and Alanine aminotransferase (ALT) = 1.5 × ULN will not directly lead to study discontinuation if bilirubin fraction test result of direct bilirubin
• Any systemic neuromuscular junction disorder (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis).
• Previous botulinum toxin treatment.
• Expected use of botulinum toxin for the treatment of any other disease during the study period.
• Known allergy to any of the components in the investigational product or iodine.
• Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria.
• Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery.
• Concurrent use of antibiotics that may interfere with neuromuscular junction function, for example, aminoglycoside antibiotics (e.g., gentamicin sulfate, fradiomycin sulfate), polypeptide antibiotics (e.g., polymixin B sulfate), tetracycline antibiotics, and lincomycin antibiotics, except for those contained in topical antimicrobials.
• Concurrent use of muscle relaxants (e.g., tubocurarin chloride hydrochloride hydrate, dantrolene sodium hydrate) or drugs that may have a muscle relaxant action (e.g. spectinomycin hydrochloride hydrate, antispasmogenics including baclofen, benzodiazepines and benzodiazepine-like drugs, benzamides).
• Chronic respiratory disorder.
• Serious muscle weakness or atrophy.
• Angle closure glaucoma or its precipitation (narrow angle).
• Dermal disorder including infection at anticipated injection sites in either axilla.
• Subject has serious physical symptom(s) (i.e., cardiac / hepatic / renal / hematopoietic disorder). The index of seriousness is Grade 3 of "criteria for classification of seriousness of adverse drug reactions to pharmaceutical products, etc. : Appendix 3" (Pharmaceutical Affairs bureau / Pharmaceutical and Chemical Safety Division (PAB / PSD) Notification No.80 in 1992).
• Anticipated need for surgery or hospitalization during the study period.
• Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period.
• Participation in another clinical study within 6 months of stu