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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycopyrronium Bromide (GPB) Cream | Experimental | Formulation containing Glycopyrronium Bromide (GPB) for topical application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrronium Bromide (GPB) Cream | Drug | Application of cream to each axilla |
|
| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Rolf-Markus Szeimies | Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Michael Sebastian | Mahlow | 15831 | Germany |
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| 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 |
| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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