Moderate to 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
Product Name: 1% GPB cream
Pharmaceutical Form: Cream
INN or Proposed INN: Glycopyrronium Bromide
CAS Number: 51186-83-5
Concentration unit: % percent
Concentration type: equal
Concentration number: 1
Sponsors
Dr. August Wolff GmbH & Co. KG Arzneimittel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of severe primary axillary hyperhidrosis with a HDSS score of 3 or 4; 2. At least 50 mg of sweat production in each axilla measured gravimetrically at room temperature and at a humidity consistent with the normal climate in that area over a period of 5 minutes (patients should have acclimatized to that room for at least 30 minutes); 3. Men and women aged 18 to 65 years at the time of informed consent with a body mass index of 18-32 kg/m²; 4. Corrected QT (QTc) =450 msec, or QTc =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known allergy to any of the components in the investigational product; 2. Hypersensitivity against glycopyrrolate; 3. Secondary hyperhidrosis, e.g. hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma, malaria and climacteric hyperhidrosis; 4. Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery; 5. Botulinum toxin treatment for the treatment of axillary hyperhidrosis in the previous 4 months; 6. Presence or history of neuromuscular disease; 7. Angle closure glaucoma or its precipitation (narrow angle); 8. Mycotic, other skin infections and other dermal disorder including infection at anticipated application sites in either axilla; 9. Significant cardiovascular disease, thyrotoxicosis and men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy; 10. Significant cardiac arrhythmia such as tachycardiac atrial fibrillation and very frequent extrasystoles; 11. Patients with uncontrolled diabetes mellitus; 12. Patients with severe renal impairment (including Gilbert’s syndrome); 13. Patients with active or clinical history of asthma (within the last 10 years) or chronic bronchitis; 14. Patients with a history of ileus, gastrointestinal stenosis, pronounced chronic inflammatory bowel disease, toxic megacolon; 15. Patients with epilepsy; 16. Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period; 17. Use of prohibited medication or treatment (see Section 11.2.1); 18. Use of investigational drugs within 30 days or 5 half-lives (whichever is longer) or participation in another clinical trial within 30 days prior to the planned first dosing; 19. Psychiatry disorder or cognitive disorder that may affect the patient's ability to give informed consent or to follow specified study procedures; 20. Positive serology test for hepatitis B or C virus, or human immunodeficiency virus 1 or 2; 21. History of alcohol or drug abuse within the last 3 years; 22. Any condition or situation that, in the investigator's or sub-investigator's opinion, may interfere with the patient's participation in the study; 23. Employees of the sponsor or sponsor’s representative; employees or relatives of the investigator; 24. Patients who are detained officially or legally to an official institute or those that have been committed to an institution by an order issued either by the judicial or the administrative authorities; 25. Any score higher than 1 (i.e. 2 or 3) in the neurological examination; 26. Patients with myasthenia gravis; 27. Patients under treatment with potassium chloride; 28. Patients with a disturbed blood-brain-barrier (such as patients with recent [within 1 year of Screening] craniocerebral trauma, chemotherapy, radiation therapy, or skull opening surgeries, or recent intravenous drug users); 29. Patients with psoriasis inversa or psoriasis pustulosa generalisata.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The assessment of efficacy and safety of topical administration of 1% GPB or placebo cream in patients with primary axillary hyperhidrosis and the assessment of long-term efficacy and safety of topical administration of 1% GPB cream in patients with primary axillary hyperhidrosis.;Secondary Objective: Not applicable;Primary end point(s): Primary endpoints: Dose-confirming part (Phase 3a): 1. Absolute change in sweat production assessed by gravimetric measurement (GM) from Baseline (Day 1a) to Day 29 in the 1% GPB group compared with the placebo group. Long-term part (Phase 3b)(only for newly recruited patients): 2. Absolute change in sweat production assessed by GM from Baseline (Day 1b) to Week 12.;Timepoint(s) of evaluation of this end point: Dose-confirming part (Phase 3a): 1. Screening Visit, Baseline (Day 1a), Day 29. Long-term part (Phase 3b)(only for newly recruited patients): 2. Screening Visit, Baseline (Day 1b), Week 4, Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: Efficacy Dose-confirming part: Key secondary endpoints 1. Percentage of responders assessed by the HDSS (=2-point improvement from Baseline) on Day 29 in the 1% GPB group compared with the placebo group; 2. Absolute change in the hyperhidrosis quality of life (HidroQOL) questionnaire from Baseline to Day 29 in the 1% GPB group compared with the placebo group. Further secondary endpoints 3. Absolute change in sweat production assessed by GM from Baseline (Day 1a) to Day 29 by treatment group; 4. Percentage change in sweat production assessed by GM from Baseline to Day 29 by treatment group and in the 1% GPB group compared with the placebo group; 5. Percentage of responders assessed by GM at Day 29 (defined by sweat reduction of =50%, =75%, and =90% compared with Baseline) in the 1% GPB group compared with the placebo group; 6. Absolute change in the HDSS from Baseline to Day 29 by treatment group and in the 1% GPB group compared with the placebo group; 7. Absolute change in the HDSS from Baseline to Day 15 by treatment group and in the 1% GPB group compared with the placebo group; 8. Percentage of responders assessed by the HDSS (=2-point improvement from Baseline) on Day 15 in the 1% GPB group compared with the placebo group; 9. Absolute change in the HidroQOL questionnaire from Baseline to Day 15 by treatment group and in the 1% GPB group compared with the placebo group; 10. Absolute change in the HidroQOL questionnaire from Baseline to Day 29 by treatment group; 11. Absolute change in the dermatology life quality index (DLQI) questionnaire from Baseline to Day 15 by treatment group and in the 1% GPB group compared with the placebo group; 12. Absolute change in the DLQI questionnaire from Baseline to Day 29 by treatment group and in the 1% GPB group compared with the placebo group. Long-term part: Key secondary endpoints 13. Percentage of responders assessed by the HDSS (=2-point improvement from Baseline) at Week 1 | — |
Countries
Austria, Denmark, Germany, Hungary, Poland, Sweden, United Kingdom
Contacts
Public ContactHead of Clinical Affairs
Dr. August Wolff GmbH & Co. KG Arzneimittel
Outcome results
None listed