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.

Study Overview

• Status: Completed
• Conditions: Primary Axillary Hyperhidrosis
• Intervention / Treatment: Drug: Glycopyrronium Bromide (GPB) Cream

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clarissa Masur; Phone Number: +49 521 8808 319; Email: clarissa.masur@drwolffgroup.com
• Study Contact Backup: Name: Gisela Straus; Phone Number: +49 89 893 119 34; Email: gisela.straus@fgk-cro.de

Study Locations

• Germany
  • Mahlow, Germany, 15831
    • Dr. Michael Sebastian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glycopyrronium Bromide (GPB) Cream; Formulation containing Glycopyrronium Bromide (GPB) for topical application	Drug: Glycopyrronium Bromide (GPB) Cream; Application of cream to each axilla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with Adverse Drug Reaction during treatment	Baseline to Day 57
Number of patients with a local tolerability assessment (skin reaction score) >0 during treatment	Baseline to Day 57
Αbsolute change in GP plasma concentration from Baseline to Day 15	Baseline to Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 29		Baseline to Day 29
Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 57		Baseline to Day 57
Absolute change in logarithmic values of total sweat production assessed by GM from Day 29 to Day 57		Day 29 to Day 57
Relative change in total sweat production assessed by GM from Baseline to Day 29 and Day 57		Baseline to Day 29 and Day 57
Relative change in total sweat production assessed by GM from Day 29 to Day 57		Day 29 to Day 57
Proportion of responders assessed by GM at Day 29 and Day 57		Day 29 and Day 57
Absolute change in patient-rated hyperhidrosis severity (PRHS) score from Baseline to Day 29 and Day 57	The patient-rated hyperhidrosis severity (PRHS) score will be assessed by asking the following question: "How did you perceive your underarm sweating in the past 24 hours? Please rate it on a scale from 0 (no sweating at all) to 10 (worst sweating that you ever had)"	Baseline to Day 29 and Day 57
Absolute change in patient-rated hyperhidrosis severity (PRHS) score from Day 29 to Day 57	The patient-rated hyperhidrosis severity (PRHS) score will be assessed by asking the following question: "How did you perceive your underarm sweating in the past 24 hours? Please rate it on a scale from 0 (no sweating at all) to 10 (worst sweating that you ever had)"	Day 29 to Day 57
Absolute change in the Children's dermatology life quality index (CDLQI) score from Baseline to Day 29 and Day 57	The Children's dermatology life quality index (CDLQI) is a simple 10-question questionnaire that assesses the burden of hyperhidrosis. It is validated for children aged 5-16 years. The answers to the questions are generally scored on a 4-point scale: 'very much' = 3, 'quite a lot' = 2, 'only a little' = 1, 'not at all' or question unanswered = 0. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more impairment of the child's life is experienced.	Baseline to Day 29 and Day 57
Absolute change in the Children's dermatology life quality index (CDLQI) score from Day 29 to Day 57	The Children's dermatology life quality index (CDLQI) is a simple 10-question questionnaire that assesses the burden of hyperhidrosis. It is validated for children aged 5-16 years. The answers to the questions are generally scored on a 4-point scale: 'very much' = 3, 'quite a lot' = 2, 'only a little' = 1, 'not at all' or question unanswered = 0. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more impairment of the child's life is experienced.	Day 29 to Day 57
Absolute change in GP plasma concentration from Baseline to Day 8		Baseline to Day 8
Absolute change in GP plasma concentration from Day 8 to Day 15		Day 8 to Day 15
Frequency, severity, and relation of ADRs, SAEs, TEAEs, SUSARs, and discontinuations due to TEAEs		Screening to 14 Days after End of Treatment
Local tolerability based on the skin reaction score	Local tolerability at the application sites will be assessed and evaluated by the investigator using a skin reaction score: 'No evidence of irritation' = 0, 'Minimal erythema, barely perceptible' = 1, 'Definite erythema, readily visible; minimal edema or minimal popular response' = 2, 'Erythema and papules' = 3, 'Definite edema' = 4, 'Erythema, edema, and papules' = 5, 'Vesicular eruption' = 6, 'Strong reaction spreading beyond test site' = 7, 'Folliculitis' = 8.	Day 1, Day 29, Day 57/End of Treatment and 14 Days after Day 57/End of Treatment
Neurological assessment of anticholinergic effects by a 4-point scale	The occurrence of possible anticholinergic effects including dry mouth, dry eyes, blurred vision, red eyes, constipation, micturition disorder, drowsiness, and concentration difficulties is rated on a 4-point scale: 'severe intensity' = 3, 'moderate intensity' = 2, 'mild intensity' = 1, 'no evidence' = 0.	7 to 4 Days before Baseline, Day 15, Day 29, Day 43, Day 57/End of Treatment

Collaborators and Investigators

• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Investigators: Principal Investigator: Prof. Rolf-Markus Szeimies, Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Actual): March 6, 2024
• Study Completion (Actual): March 6, 2024

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Excessive sweating
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Anticonvulsants; Glycopyrrolate; Bromides
• Other Study ID Numbers: GPBK-08/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No