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Clinical Trials/NCT01128738
NCT01128738CompletedPhase 3

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Including an Open-label Phase to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Axillary Hyperhidrosis

GlaxoSmithKline1 site in 1 country152 target enrollmentStarted: April 2010Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
152
Locations
1
Primary Endpoint
Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The primary objective of this study is to demonstrate superiority of single treatment of GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal injections based on gravimetric assessment (measurement of spontaneous axillary sweat production) for axillary hyperhidrosis.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •<At start of the screening phase (Visit 1)>
  • •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
  • •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).
  • •QTc <450 msec, or QTc <480 msec in patients with bundle branch block. (QTc should be determined on one beat on echocardiogram (ECG) or determined by average on consecutive three beats.)
  • •Willing and able to provide written informed consent. <At start of the treatment phase (Visit 2)>
  • •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
  • •Asparate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2 x upper limit of normal (ULN), Alkaline phosphatase (ALP) and bilirubin <= 1.5 x ULN at Visit 1 (Free bilirubin >= 1.5 × ULN will not directly lead to study discontinuation if bilirubin fraction test result of direct bilirubin <35% is available.)

Exclusion Criteria

  • •<At start of the screening phase (Visit 1)>
  • •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 study entry or planned participation in another clinical study after entry to this study.
  • •Psychiatry disorder or cognitive disorder that may affect the patient's ability to give informed consent or to follow specified study procedures.
  • •History of alcohol or drug abuse.
  • •Any condition or situation that, in the investigator's or subinvestigator's opinion, may interfere with the patient's participation in the study.
  • •<At start of the treatment phase (Visit 2)>
  • •Use of cholinomimetics, anticholinergics, antiperspirants containing aluminum chloride and deodorants, any oral herbal medicine treatments or any other topical treatments for hyperhidrosis within 7 days prior to study treatment..
  • •Underarm hair removed within 12 hours prior to study treatment or not removed sufficiently.
  • •Any condition or situation that, in the investigator's or subinvestigator's opinion, may interfere with the patient's participation in the study.

Arms & Interventions

GSK1358820

Active Comparator

Onabotulinum toxin type A

Intervention: GSK1358820 (Drug)

Placebo

Placebo Comparator

Placebo

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase

Time Frame: Week 4

A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.

Secondary Outcomes

  • Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase(Weeks 1, 8 ,12, 16, 20, and 24)
  • Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase(Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 24)
  • Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase(Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24)
  • Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase(Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase(Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase(Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40)
  • Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase(Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase)
  • Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase(Baseline (Week 0); Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase)
  • Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase(Baseline (Week 0); and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase)
  • Percentage of Responders Assessed by the HDSS in the Second Treatment Phase(Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase(Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase(Weeks 4 (Study Week 20 to Week 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase)
  • Duration of Effect(Up to Week 40)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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