Primary Axillary Hyperhidrosis
Conditions
Keywords
Excessive sweating
Brief summary
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.
Interventions
DRUGGlycopyrronium Bromide (GPB) Cream
Application of cream to each axilla
Sponsors
Dr. August Wolff GmbH & Co. KG Arzneimittel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
| Absolute change in patient-rated hyperhidrosis severity (PRHS) score from Day 29 to Day 57 | 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) |
| Absolute change in the Children's dermatology life quality index (CDLQI) score from Baseline to Day 29 and Day 57 | 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. |
| Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 29 | Baseline to Day 29 | — |
| 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 | Day 1, Day 29, Day 57/End of Treatment and 14 Days after Day 57/End of Treatment | 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. |
| Neurological assessment of anticholinergic effects by a 4-point scale | 7 to 4 Days before Baseline, Day 15, Day 29, Day 43, Day 57/End of Treatment | 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. |
| Absolute change in the Children's dermatology life quality index (CDLQI) score from Day 29 to Day 57 | 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. |
| 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 | — |
Countries
Germany
Outcome results
None listed