Primary Axillary Hyperhidrosis
Conditions
Keywords
Excessive sweating
Brief summary
The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.
Interventions
DRUGWO3979
Application of cream to each axilla
DRUGWO3970
Application of cream to each axilla
DRUGWO3992
Application of cream to each axilla
DRUGPlacebo (WO3988)
Application of cream to each axilla
Sponsors
Nuvisan GmbH
FGK Clinical Research GmbH
Charles River Biopharmaceutical Services GmbH
Dr. August Wolff GmbH & Co. KG Arzneimittel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of moderate to severe primary axillary hyperhidrosis whose HDSS score is 2, 3 or 4 * At least 50 mg in males or 25 mg in females of spontaneous resting axillary sweat production in one axilla measured gravimetrically at room temperature/humidity (about 25°C / 20-50%) over a period of 5 minutes. * Male and female subjects in the age of 18 to 65 years at the time of informed consent and a body mass index (BMI) of 18-32 kg/m2. * Corrected QT (QTc) ≤450 msec, or QTc \<480 msec in subjects with bundle branch block. * Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol subjects. * Willing and able to provide written informed consent.
Exclusion criteria
* Known allergy to any of the components in the investigational product. * Hypersensitivity against glycopyrrolate * Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria, climacteric hyperhidrosis. * Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery. * Botulinum toxin treatment in the prior 9 months. * Present or history of neuromuscular disease. * Angle closure glaucoma or its precipitation (narrow angle). * Mycotic, other skin infections and other dermal disorder including infection at anticipated application sites in either axilla. * Significant cardiac arrhythmia such as tachycardiac atrial fibrillation and very frequent extrasystoles. * Subject with diabetes mellitus. * Subjects with ileus, gastrointestinal stenosis, pronounced chronic inflammatory bowel disease, toxic megacolon. * Subjects with epilepsy. * Use of antiperspirants containing aluminium chloride and deodorants, any oral herbal medicine treatments or any other topical treatments for hyperhidrosis within 7 days prior to study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability and safety assessed through adverse events and local skin reactions | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Gravimetric measurement of sweat production | 3 weeks |
| Dermatology Life Quality Index (DLQI) | 3 weeks |
| Hyperhidrosis Disease Severity Scale (HDSS) | 3 weeks |
Countries
Germany
Outcome results
None listed