Assessment of Efficacy and Safety of Topical Administration of 1% Glycopyrronium Bromide (GPB) in Patients With Primary Axillary Hyperhidrosis and the Assessment of Long-term Efficacy and Safety of Topical Administration of 1% GPB Cream in Patients

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate the efficacy and safety of 1% GPB cream after 4 weeks of treatment compared with placebo with a sufficient number of patients to obtain statistically significant results, and to assess the long-term safety of 1% GPB cream.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of severe primary axillary hyperhidrosis with a HDSS score of 3 or 4

• At least 50 mg of sweat production in each axilla measured gravimetrically at room temperature and at a humidity consistent with the normal climate in that area over a period of 5 minutes (patients should have acclimatized to that room for at least 30 minutes)

• Men and women aged 18 to 65 years at the time of informed consent with a body mass index of 18-32 kg/m2

• 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 4 months.

• 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.

• Any condition or situation that, in the investigator's or sub-investigator's opinion, may interfere with the patient's participation in the study;