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

Dr. August Wolff

Status and phase

Completed

Phase 2

Conditions

Primary Axillary Hyperhidrosis

Treatments

Drug: Glycopyrronium Bromide (GPB) Cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT05863104

GPBK-08/2018

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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)