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

Dr. August Wolff

Status and phase: Completed; Phase 1

Conditions: Primary Axillary Hyperhidrosis

Treatments: Drug: Placebo (WO3988); Drug: WO3970; Drug: WO3979; Drug: WO3992

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03037788

2015-005570-38 (EudraCT Number)

Hyp-02/2015

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 4 patient groups, including a placebo group

WO3979

Experimental group

Description:

Formulation containing WO3979 for topical application

Treatment:

Drug: WO3979

WO3970

Experimental group

Description:

Formulation containing WO3970 for topical application

Treatment:

Drug: WO3970

WO3992

Experimental group

Description:

Formulation containing WO3992 for topical application

Treatment:

Drug: WO3992

Placebo of WO3988

Placebo Comparator group

Description:

Formulation containing Placebo of WO3988 for topical application

Treatment:

Drug: Placebo (WO3988)