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 With Primary Axillary Hyperhidrosis.

Dr. August Wolff

Status and phase

Completed

Phase 3

Conditions

Primary Axillary Hyperhidrosis

Treatments

Drug: Placebo (WO3988)

Drug: WO3970

Study type

Interventional

Funder types

Industry

Identifiers

NCT03658616

Hyp1-18/2016

Details and patient eligibility

About

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.

Enrollment

518 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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;