Investigation of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in Subjects With Axillary Hyperhidrosis

Phase 1

Completed

• Conditions: Primary Axillary Hyperhidrosis
• Interventions: Drug: WO3979; Drug: WO3970; Drug: WO3992; Drug: Placebo (WO3988)

• Registration Number: NCT03037788
• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Primary Completion: 2017-06
• Status Verified: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WO3979	WO3979	Formulation containing WO3979 for topical application
WO3970	WO3970	Formulation containing WO3970 for topical application
WO3992	WO3992	Formulation containing WO3992 for topical application
Placebo of WO3988	Placebo (WO3988)	Formulation containing Placebo of WO3988 for topical application

Primary Outcome Measures

Name	Time	Method
Tolerability and safety assessed through adverse events and local skin reactions	3 weeks

Secondary Outcome Measures

Name	Time	Method
Hyperhidrosis Disease Severity Scale (HDSS)	3 weeks
Dermatology Life Quality Index (DLQI)	3 weeks
Gravimetric measurement of sweat production	3 weeks

Trial Locations

Locations (1)

Nuvisan GmbH; 🇩🇪 Neu-Ulm, Germany