Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis

An Open-label, Uncontrolled, Multicenter Study to Evaluate the Safety, Local Tolerability, Systemic Exposure, and Efficacy of 1% Glycopyrronium Bromide (GPB) Cream in Adolescents With Severe Primary Axillary Hyperhidrosis

The aim of this study is to evaluate the safety, tolerability and systemic exposure (in a subset of patients) of topical administration of 1% GPB in adolescents with severe primary axillary hyperhidrosis.

Inclusion Criteria:

• Medical diagnosis of severe primary axillary hyperhidrosis with a PRHS score of ≥5 with symptoms for at least 3 months before Screening
• At least 50 mg of sweat production in each axilla measured gravimetrically over a period of 5 minutes at room temperature along with a humidity consistent with the normal climate in that area (patients have to acclimatize to that room for at least 30 minutes before the measurement)
• Adolescents of both sexes aged 12 to 17 years (until study completion) with a body mass index percentile ≥10 and ≤90 (according to Kromeyer-Hauschild et al 2001)
• Local tolerability assessment (skin reaction) score = 0

Exclusion Criteria:

• Secondary hyperhidrosis, ie, hyperhidrosis that is secondary to other underlying diseases such as (but not limited to) hyperthyroidism, lymphoma, and malaria
• Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage, ultrasonic surgery, microwave treatment (miraDry), or laser treatment
• Botulinum toxin treatment for the treatment of axillary hyperhidrosis in the previous 4 months
• Hypersensitivity to glycopyrrolate, or to any of the excipients of the investigational medicinal product (IMP)