Clinical trial NCT03037788: Investigation of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in Subjects With Axillary Hyperhidrosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Axillary Hyperhidrosis
Keywords: Excessive sweating
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
Collaborators: name: Nuvisan GmbH
name: FGK Clinical Research GmbH
name: Charles River Biopharmaceutical Services GmbH
First posted: 2017-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tolerability and safety assessed through adverse events and local skin reactions
timeFrame: 3 weeks
Secondary outcomes:
measure: Gravimetric measurement of sweat production
timeFrame: 3 weeks
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 3 weeks
measure: Hyperhidrosis Disease Severity Scale (HDSS)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
facility: Nuvisan GmbH
Study officials:
affiliation: Dr. August Wolff GmbH & Co. KG Arzneimittel
name: Prof. Christoph Abels, MD, PhD
role: STUDY_DIRECTOR
affiliation: Nuvisan GmbH
name: Horst Jürgen Heuer, MD
role: PRINCIPAL_INVESTIGATOR
References: