Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-02 @ 2:38 AM
Study NCT ID:
NCT05863104
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2023-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006945', 'term': 'Hyperhidrosis'}], 'ancestors': [{'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006024', 'term': 'Glycopyrrolate'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2023-04-27', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with Adverse Drug Reaction during treatment', 'timeFrame': 'Baseline to Day 57'}, {'measure': 'Number of patients with a local tolerability assessment (skin reaction score) >0 during treatment', 'timeFrame': 'Baseline to Day 57'}, {'measure': 'Αbsolute change in GP plasma concentration from Baseline to Day 15', 'timeFrame': 'Baseline to Day 15'}], 'secondaryOutcomes': [{'measure': 'Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 29', 'timeFrame': 'Baseline to Day 29'}, {'measure': 'Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 57', 'timeFrame': 'Baseline to Day 57'}, {'measure': 'Absolute change in logarithmic values of total sweat production assessed by GM from Day 29 to Day 57', 'timeFrame': 'Day 29 to Day 57'}, {'measure': 'Relative change in total sweat production assessed by GM from Baseline to Day 29 and Day 57', 'timeFrame': 'Baseline to Day 29 and Day 57'}, {'measure': 'Relative change in total sweat production assessed by GM from Day 29 to Day 57', 'timeFrame': 'Day 29 to Day 57'}, {'measure': 'Proportion of responders assessed by GM at Day 29 and Day 57', 'timeFrame': 'Day 29 and Day 57'}, {'measure': 'Absolute change in patient-rated hyperhidrosis severity (PRHS) score from Baseline to Day 29 and Day 57', 'timeFrame': 'Baseline to Day 29 and Day 57', 'description': '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)"'}, {'measure': 'Absolute change in patient-rated hyperhidrosis severity (PRHS) score from Day 29 to Day 57', 'timeFrame': 'Day 29 to Day 57', 'description': '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)"'}, {'measure': "Absolute change in the Children's dermatology life quality index (CDLQI) score from Baseline to Day 29 and Day 57", 'timeFrame': 'Baseline to Day 29 and Day 57', 'description': "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.\n\nThe 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."}, {'measure': "Absolute change in the Children's dermatology life quality index (CDLQI) score from Day 29 to Day 57", 'timeFrame': 'Day 29 to Day 57', 'description': "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.\n\nThe 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."}, {'measure': 'Absolute change in GP plasma concentration from Baseline to Day 8', 'timeFrame': 'Baseline to Day 8'}, {'measure': 'Absolute change in GP plasma concentration from Day 8 to Day 15', 'timeFrame': 'Day 8 to Day 15'}, {'measure': 'Frequency, severity, and relation of ADRs, SAEs, TEAEs, SUSARs, and discontinuations due to TEAEs', 'timeFrame': 'Screening to 14 Days after End of Treatment'}, {'measure': 'Local tolerability based on the skin reaction score', 'timeFrame': 'Day 1, Day 29, Day 57/End of Treatment and 14 Days after Day 57/End of Treatment', 'description': "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."}, {'measure': 'Neurological assessment of anticholinergic effects by a 4-point scale', 'timeFrame': '7 to 4 Days before Baseline, Day 15, Day 29, Day 43, Day 57/End of Treatment', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Excessive sweating'], 'conditions': ['Primary Axillary Hyperhidrosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical diagnosis of severe primary axillary hyperhidrosis with a PRHS score of ≥5 with symptoms for at least 3 months before Screening\n* 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)\n* 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)\n* Local tolerability assessment (skin reaction) score = 0\n\nExclusion Criteria:\n\n* Secondary hyperhidrosis, ie, hyperhidrosis that is secondary to other underlying diseases such as (but not limited to) hyperthyroidism, lymphoma, and malaria\n* Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage, ultrasonic surgery, microwave treatment (miraDry), or laser treatment\n* Botulinum toxin treatment for the treatment of axillary hyperhidrosis in the previous 4 months\n* Hypersensitivity to glycopyrrolate, or to any of the excipients of the investigational medicinal product (IMP)'}, 'identificationModule': {'nctId': 'NCT05863104', 'briefTitle': 'Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. August Wolff GmbH & Co. KG Arzneimittel'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GPBK-08/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glycopyrronium Bromide (GPB) Cream', 'description': 'Formulation containing Glycopyrronium Bromide (GPB) for topical application', 'interventionNames': ['Drug: Glycopyrronium Bromide (GPB) Cream']}], 'interventions': [{'name': 'Glycopyrronium Bromide (GPB) Cream', 'type': 'DRUG', 'description': 'Application of cream to each axilla', 'armGroupLabels': ['Glycopyrronium Bromide (GPB) Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15831', 'city': 'Mahlow', 'country': 'Germany', 'facility': 'Dr. Michael Sebastian', 'geoPoint': {'lat': 52.36017, 'lon': 13.40954}}], 'overallOfficials': [{'name': 'Prof. Rolf-Markus Szeimies', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. August Wolff GmbH & Co. KG Arzneimittel', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}