Back to resultsAssessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis
Primary Purpose
Primary Axillary Hyperhidrosis
Status
Recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Glycopyrronium Bromide (GPB) Cream
Sponsored by
About this trial
This is an interventional treatment trial for Primary Axillary Hyperhidrosis focused on measuring Excessive sweating
Eligibility Criteria
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)
Sites / Locations
- Dr. Michael SebastianRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Glycopyrronium Bromide (GPB) Cream
Arm Description
Formulation containing Glycopyrronium Bromide (GPB) for topical application
Outcomes
Primary Outcome Measures
Number of patients with Adverse Drug Reaction during treatment
Number of patients with a local tolerability assessment (skin reaction score) >0 during treatment
Αbsolute change in GP plasma concentration from Baseline to Day 15
Secondary Outcome Measures
Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 29
Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 57
Absolute change in logarithmic values of total sweat production assessed by GM from Day 29 to Day 57
Relative change in total sweat production assessed by GM from Baseline to Day 29 and Day 57
Relative change in total sweat production assessed by GM from Day 29 to Day 57
Proportion of responders assessed by GM at 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)"
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)"
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.
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.
Absolute change in GP plasma concentration from Baseline to Day 8
Absolute change in GP plasma concentration from Day 8 to Day 15
Frequency, severity, and relation of ADRs, SAEs, TEAEs, SUSARs, and discontinuations due to TEAEs
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.
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.
Full Information
NCT ID
NCT05863104
First Posted
April 27, 2023
Last Updated
May 8, 2023
Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
1. Study Identification
Unique Protocol Identification Number
NCT05863104
Brief Title
Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Axillary Hyperhidrosis
Keywords
Excessive sweating
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glycopyrronium Bromide (GPB) Cream
Arm Type
Experimental
Arm Description
Formulation containing Glycopyrronium Bromide (GPB) for topical application
Intervention Type
Drug
Intervention Name(s)
Glycopyrronium Bromide (GPB) Cream
Intervention Description
Application of cream to each axilla
Primary Outcome Measure Information:
Title
Number of patients with Adverse Drug Reaction during treatment
Time Frame
Baseline to Day 57
Title
Number of patients with a local tolerability assessment (skin reaction score) >0 during treatment
Time Frame
Baseline to Day 57
Title
Αbsolute change in GP plasma concentration from Baseline to Day 15
Time Frame
Baseline to Day 15
Secondary Outcome Measure Information:
Title
Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 29
Time Frame
Baseline to Day 29
Title
Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 57
Time Frame
Baseline to Day 57
Title
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
Title
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
Title
Relative change in total sweat production assessed by GM from Day 29 to Day 57
Time Frame
Day 29 to Day 57
Title
Proportion of responders assessed by GM at Day 29 and Day 57
Time Frame
Day 29 and Day 57
Title
Absolute change in patient-rated hyperhidrosis severity (PRHS) score from 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)"
Time Frame
Baseline to Day 29 and Day 57
Title
Absolute change in patient-rated hyperhidrosis severity (PRHS) score from 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)"
Time Frame
Day 29 to Day 57
Title
Absolute change in the Children's dermatology life quality index (CDLQI) score from 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.
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
Title
Absolute change in the Children's dermatology life quality index (CDLQI) score from 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.
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
Title
Absolute change in GP plasma concentration from Baseline to Day 8
Time Frame
Baseline to Day 8
Title
Absolute change in GP plasma concentration from Day 8 to Day 15
Time Frame
Day 8 to Day 15
Title
Frequency, severity, and relation of ADRs, SAEs, TEAEs, SUSARs, and discontinuations due to TEAEs
Time Frame
Screening to 14 Days after End of Treatment
Title
Local tolerability based on the skin reaction score
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.
Time Frame
Day 1, Day 29, Day 57/End of Treatment and 14 Days after Day 57/End of Treatment
Title
Neurological assessment of anticholinergic effects by a 4-point scale
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.
Time Frame
7 to 4 Days before Baseline, Day 15, Day 29, Day 43, Day 57/End of Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clarissa Masur
Phone
+49 521 8808 319
Email
clarissa.masur@drwolffgroup.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gisela Straus
Phone
+49 89 893 119 34
Email
gisela.straus@fgk-cro.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Rolf-Markus Szeimies
Organizational Affiliation
Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Michael Sebastian
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Sebastian, MD
12. IPD Sharing Statement
Learn more about this trial
Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis
We'll reach out to this number within 24 hrs