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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Axillary Hyperhidrosis
• Intervention / Treatment: Drug: WO3970; Drug: Placebo (WO3988); Drug: WO3979; Drug: WO3992

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neu-Ulm, Germany, 89231
    • Nuvisan GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo of WO3988; Formulation containing Placebo of WO3988 for topical application	Drug: Placebo (WO3988); Application of cream to each axilla
Experimental: WO3979; Formulation containing WO3979 for topical application	Drug: WO3979; Application of cream to each axilla
Experimental: WO3970; Formulation containing WO3970 for topical application	Drug: WO3970; Application of cream to each axilla
Experimental: WO3992; Formulation containing WO3992 for topical application	Drug: WO3992; Application of cream to each axilla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tolerability and safety assessed through adverse events and local skin reactions	3 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Collaborators: FGK Clinical Research GmbH; Nuvisan GmbH; Charles River Biopharmaceutical Services GmbH
• Investigators: Study Director: Prof. Christoph Abels, MD, PhD, Dr. August Wolff GmbH & Co. KG Arzneimittel; Principal Investigator: Horst Jürgen Heuer, MD, Nuvisan GmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Excessive sweating
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: Hyp-02/2015; 2015-005570-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No