NCT05863104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2024

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 27, 2023

Last Update Submit

April 3, 2024

Conditions

Primary Axillary Hyperhidrosis

Keywords

Excessive sweating

Outcome Measures

Primary Outcomes (3)

  • Number of patients with Adverse Drug Reaction during treatment

    Baseline to Day 57

  • Number of patients with a local tolerability assessment (skin reaction score) >0 during treatment

    Baseline to Day 57

  • Αbsolute change in GP plasma concentration from Baseline to Day 15

    Baseline to Day 15

Secondary Outcomes (15)

  • Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 29

    Baseline to Day 29

  • Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 57

    Baseline to Day 57

  • Absolute change in logarithmic values of total sweat production assessed by GM from Day 29 to Day 57

    Day 29 to Day 57

  • Relative change in total sweat production assessed by GM from Baseline to Day 29 and Day 57

    Baseline to Day 29 and Day 57

  • Relative change in total sweat production assessed by GM from Day 29 to Day 57

    Day 29 to Day 57

  • +10 more secondary outcomes

Study Arms (1)

Glycopyrronium Bromide (GPB) Cream

EXPERIMENTAL

Formulation containing Glycopyrronium Bromide (GPB) for topical application

Drug: Glycopyrronium Bromide (GPB) Cream

Interventions

Glycopyrronium Bromide (GPB) CreamDRUG

Application of cream to each axilla

Glycopyrronium Bromide (GPB) Cream

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Michael Sebastian

Mahlow, 15831, Germany

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Prof. Rolf-Markus Szeimies

    Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 17, 2023

Study Start

March 7, 2023

Primary Completion

March 6, 2024

Study Completion

March 6, 2024

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations

DE(1)