Primary Axillary HyperhidrosisPhase 2NCT05863104
Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis
A Phase 2 study testing Glycopyrronium Bromide (GPB) Cream in people with Primary Axillary Hyperhidrosis, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Primary Axillary Hyperhidrosis
- What is being tested?
- Glycopyrronium Bromide (GPB) Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 7 Mar 2023to 6 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Primary Axillary Hyperhidrosis
- Being tested
- Glycopyrronium Bromide (GPB) Cream
- Keywords
- Excessive sweating
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycopyrronium Bromide (GPB) CreamDrug
Application of cream to each axilla
| Study group | Role | What they receive |
|---|---|---|
| Glycopyrronium Bromide (GPB) Cream | Experimental | Formulation containing Glycopyrronium Bromide (GPB) for topical application Receives: Drug: Glycopyrronium Bromide (GPB) Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Adverse Drug Reaction during treatment
Measured: Baseline to Day 57
Number of patients with a local tolerability assessment (skin reaction score) >0 during treatment
Measured: Baseline to Day 57
Αbsolute change in GP plasma concentration from Baseline to Day 15
Measured: Baseline to Day 15
Secondary outcomes (15)
Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 29
Measured: Baseline to Day 29
Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 57
Measured: Baseline to Day 57
Absolute change in logarithmic values of total sweat production assessed by GM from Day 29 to Day 57
Measured: Day 29 to Day 57
Relative change in total sweat production assessed by GM from Baseline to Day 29 and Day 57
Measured: Baseline to Day 29 and Day 57
Relative change in total sweat production assessed by GM from Day 29 to Day 57
Measured: Day 29 to Day 57
Proportion of responders assessed by GM at Day 29 and Day 57
Measured: 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)"
Measured: 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)"
Measured: 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.
Measured: 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.
Measured: Day 29 to Day 57
Absolute change in GP plasma concentration from Baseline to Day 8
Measured: Baseline to Day 8
Absolute change in GP plasma concentration from Day 8 to Day 15
Measured: Day 8 to Day 15
Frequency, severity, and relation of ADRs, SAEs, TEAEs, SUSARs, and discontinuations due to TEAEs
Measured: 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.
Measured: 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.
Measured: 7 to 4 Days before Baseline, Day 15, Day 29, Day 43, Day 57/End of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start7 Mar 2023
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Axillary HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Rolf-Markus Szeimies, Principal investigator, Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863104
- Sponsor's protocol ID
- GPBK-08/2018
- Status last verified
- Apr 2024
- First submitted
- 27 Apr 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05863104
- Acronym / sponsor ID
- GPBK-08/2018
- Conditions
- Primary Axillary Hyperhidrosis
- Keywords
- Excessive sweating
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glycopyrronium Bromide (GPB) Cream | Experimental | Drug: Glycopyrronium Bromide (GPB) CreamFormulation containing Glycopyrronium Bromide (GPB) for topical application |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycopyrronium Bromide (GPB) CreamApplication of cream to each axilla | Drug | Glycopyrronium Bromide (GPB) Cream |
Primary outcome
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
15 secondary outcomes
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
Time frame: Baseline to Day 29 and Day 57
Absolute change in patient-rated hyperhidrosis severity (PRHS) score from Day 29 to Day 57
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
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
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
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
Time frame: 7 to 4 Days before Baseline, Day 15, Day 29, Day 43, Day 57/End of Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Rolf-Markus Szeimies principal investigator
Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glycopyrronium Bromide (GPB) Cream in people with Primary Axillary Hyperhidrosis, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Adverse Drug Reaction during treatment (time frame: Baseline to Day 57). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.