Severe primary axillary hyperhidrosis MedDRA version: 20.0 Level: PT Classification code 10020642 Term: Hyperhidrosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Axhidrox 2.2 mg/pump actuation cream
Product Name: 1% GPB cream
Pharmaceutical Form: Cream
INN or Proposed INN: Glycopyrronium Bromide
CAS Number: 51186-83-5
Concentration unit: % percent
Sponsors
Dr. August Wolff GmbH & Co. KG Arzneimittel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Medical diagnosis of severe primary axillary hyperhidrosis with symptoms for at least 3 months before Screening and with a PRHS score of =5 at Screening 2 and Day 1 2. 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) at Screening 2 3. Adolescents of both sexes aged 12 to 17 years (until study completion) with a body mass index percentile =10 and =90 4. Local tolerability assessment (skin reaction) score = 0 5. Patient and legal guardians are willing and able to comply with protocol requirements, including blood sample collection 6. Patient and legal guardians are capable of understanding the nature, significance, and implications of the clinical study and to form a rational intention in the light of the facts, voluntarily agree to participation and the study’s provisions, and legal guardians have duly signed the informed consent form Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hyperhidrosis-related exclusion criteria: 1. Secondary hyperhidrosis, ie, hyperhidrosis that is secondary to other underlying diseases (such as but not limited to hyperthyroidism, lymphoma, and malaria) or secondary to the use of medication (such as but not limited to antidepressants or sympathomimetics) 2. Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage, ultrasonic surgery, microwave treatment (miraDry), or laser treatment 3. Botulinum toxin treatment for the treatment of axillary hyperhidrosis in the previous 4 months Medical history and concomitant disease exclusion criteria: 4. Hypersensitivity to glycopyrronium and its salts (such as glycopyrronium bromide), or to any of the excipients of the investigational medicinal product (IMP) 5. Corrected QT (QTc) >450 msec, or QTc =480 msec in patients with bundle branch block 6. Aspartate aminotransferase and alanine aminotransferase =2 x upper limit of normal (ULN), alkaline phosphatase and bilirubin >1.5 x ULN at Screening (free bilirubin >1.5 × ULN is acceptable if bilirubin fraction test result of direct bilirubin 10) or past depression 29. Active hepatitis B or C virus, or HIV-1 or -2 infection (serology test) 30. Active or past alcohol or drug abuse (including abuse of steroids such as, eg, testosterone, methyltestosterone, danazol, or oxandrolone) 31. Any score >1 in the neurological assessment of anticholinergic effects at Screening or Day 1 32. Current treatment with potassium chloride 33. Known disturbed blood-brain barrier (such as patients with recent [within 1 year of Screening] craniocerebral trauma, chemotherapy, radiation therapy, surgery to the skull and brain, or recent intravenous drug users) 34. Psoriasis inversa or psoriasis pustulosa generalisata 35. Any condition or situation that, in the investigator’s opinion, may interfere with the patient’s participation G
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The evaluation of the safety, tolerability and systemic exposure (in a subset of patients) of topical administration of 1% GPB in adolescents with severe primary axillary hyperhidrosis.;Secondary Objective: Key secondary objective: The evaluation of the efficacy of topical administration of 1% GPB in adolescents with severe primary axillary hyperhidrosis.;Primary end point(s): Primary endpoints: 1. Number of patients with ADRs during treatment 2. Number of patients with a local tolerability assessment (skin reaction score) >0 during treatment 3. Absolute change in glycopyrronium (GP) plasma concentration from Baseline to Day 15;Timepoint(s) of evaluation of this end point: 1. Baseline to Day 57 until SFU 2. Baseline, Day 29, Day 57 3. Baseline, Day 8, Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoint: 4. Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 29 Secondary endpoints: 5. Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 57 6. Absolute change in logarithmic values of total sweat production assessed by GM from Day 29 to Day 57 7. Relative change in total sweat production assessed by GM from Baseline to Day 29 and Day 57 8. Relative change in total sweat production assessed by GM from Day 29 to Day 57 9. Proportion of responders assessed by GM at Day 29 and Day 57 (defined by sweat reduction of =50%, =75%, =90% from Baseline) 10. Absolute change in PRHS from Baseline to Day 29 and Day 57 11. Absolute change in PRHS from Day 29 to Day 57 12. Absolute change in the CDLQI score from Baseline to Day 29 and Day 57 13. Absolute change in the CDLQI score from Day 29 to Day 57 14. Absolute change in GP plasma concentration from Baseline to Day 8 15. Absolute change in GP plasma concentration from Day 8 to Day 15 16. Frequency, severity, and relationship to the IMP of ADRs, SAEs, TEAEs, SUSARs, and discontinuations due to TEAEs 17. Local tolerability based on the skin reaction score 18. Neurological assessment of anticholinergic effects 19. Safety laboratory 20. 12-lead ECG 21. Vital signs (heart rate, blood pressure, and body temperature) 22. Product use per 4 weeks;Timepoint(s) of evaluation of this end point: Key secondary Endpoints: 4. Baseline, Day 29 Secondary Endpoints: 5. Baseline, Day 29, Day 57 6. Day 29, Day 57 7. Baseline, Day 29, Day 57 8. Day 29 to Day 57 9. Baseline, Day 29, Day 57 10. Baseline, Day 29, Day 57 11. Day 29, Day 57 12. Baseline, Day 29, Day 57 13. Day 29, Day 57 14. Baseline, Day 8 15. Day 8, Day 15 16. Baseline to Day 57 until SFU 17. Baseline, Day 29, Day 57 18. Baseline, Day 15, Day 29, Day 43, Day 57 19. Baseline, Day 29, Day 57 (SFU) 20. Baseline, Day 57 21. Baseline, Day 57 22. Ba | — |
Countries
Germany, Poland
Contacts
Public ContactHead of Clinical Affairs
Dr. August Wolff GmbH & Co. KG Arzneimittel
Outcome results
None listed