A Phase 2 interventional study of Glycopyrronium Bromide (GPB) Cream in Primary Axillary Hyperhidrosis, sponsored by Dr. August Wolff GmbH & Co. KG Arzneimittel. Completed at 1 site in Germany. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Dr. August Wolff GmbH & Co. KG Arzneimittel · Phase 2, Interventional, and Treatment
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.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 44 is below the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Dr. August Wolff GmbH & Co. KG Arzneimittel is the lead sponsor of 18 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Formulation containing Glycopyrronium Bromide (GPB) for topical application
Drug: Glycopyrronium Bromide (GPB) Cream
Application of cream to each axilla
Number of patients with Adverse Drug Reaction during treatment
Time frame: Baseline to Day 57
Number of patients with a local tolerability assessment (skin reaction score) >0 during treatment
Time frame: Baseline to Day 57
Αbsolute change in GP plasma concentration from Baseline to Day 15
Time frame: Baseline to Day 15
Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 29
Time frame: Baseline to Day 29
Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 57
Time frame: Baseline to Day 57
Absolute change in logarithmic values of total sweat production assessed by GM from Day 29 to Day 57
Time frame: Day 29 to Day 57
Relative change in total sweat production assessed by GM from Baseline to Day 29 and Day 57
Time frame: Baseline to Day 29 and Day 57
Relative change in total sweat production assessed by GM from Day 29 to Day 57
Time frame: Day 29 to Day 57
Proportion of responders assessed by GM at Day 29 and Day 57
Time frame: 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)"
Time frame: 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)"
Time frame: 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.
Time frame: 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.
Time frame: Day 29 to Day 57
Absolute change in GP plasma concentration from Baseline to Day 8
Time frame: Baseline to Day 8
Absolute change in GP plasma concentration from Day 8 to Day 15
Time frame: Day 8 to Day 15
Frequency, severity, and relation of ADRs, SAEs, TEAEs, SUSARs, and discontinuations due to TEAEs
Time frame: 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.
Time frame: 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.
Time frame: 7 to 4 Days before Baseline, Day 15, Day 29, Day 43, Day 57/End of Treatment
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glycopyrrolate
Dr. August Wolff GmbH & Co. KG Arzneimittel