Clinical trial NCT05863104: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Axillary Hyperhidrosis
Keywords: Excessive sweating
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
First posted: 2023-05-17
Enrollment: 44
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
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
Secondary outcomes:
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
measure: Absolute change in patient-rated hyperhidrosis severity (PRHS) score from Day 29 to Day 57
timeFrame: Day 29 to Day 57
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
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
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
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
Other outcomes:
Locations:
city: Mahlow
country: Germany
facility: Dr. Michael Sebastian
Study officials:
affiliation: Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
name: Prof. Rolf-Markus Szeimies
role: PRINCIPAL_INVESTIGATOR
References: