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

Primary Axillary Hyperhidrosis Clinical Trial

Official title:

Pharmacokinetics, Local and Systemic Tolerability and Local Efficacy of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in a Placebo Controlled, Double Blind Study in Subjects With Axillary Hyperhidrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037788
• Other study ID #: Hyp-02/2015
• Secondary ID: 2015-005570-38
• Status: Completed
• Phase: Phase 1
• Start date: November 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperhidrosis
• Primary Axillary Hyperhidrosis

Intervention

Drug:
• WO3979
Application of cream to each axilla
• WO3970
Application of cream to each axilla
• WO3992
Application of cream to each axilla
• Placebo (WO3988)
Application of cream to each axilla

Locations

Country	Name	City	State
Germany	Nuvisan GmbH	Neu-Ulm

Sponsors (4)

Lead Sponsor	Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel	Charles River Biopharmaceutical Services GmbH, FGK Clinical Research GmbH, Nuvisan GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability and safety assessed through adverse events and local skin reactions		3 weeks
Secondary	Gravimetric measurement of sweat production		3 weeks
Secondary	Dermatology Life Quality Index (DLQI)		3 weeks
Secondary	Hyperhidrosis Disease Severity Scale (HDSS)		3 weeks