Primary Axillary Hyperhidrosis
Conditions
Keywords
Excessive sweating
Brief summary
The aim of this study is to investigate the safety, tolerability and efficacy of 1% GPB Cream compared to Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use under maximum use conditions.
Interventions
DRUGWO3970
Application of cream to each axilla
DRUGQbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only
Sponsors
Therapeutics, Inc.
Dr. August Wolff GmbH & Co. KG Arzneimittel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of severe primary axillary hyperhidrosis with a HDSS score of 3 or 4 * 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) * Men and women aged 18 to 65 years at the time of informed consent with a body mass index of 18-32 kg/m2 * Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol subjects * Willing and able to provide written informed consent
Exclusion criteria
* Known allergy to any of the components in the investigational product. * Hypersensitivity against glycopyrrolate * Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria, climacteric hyperhidrosis. * Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery. * Botulinum toxin treatment in the prior 4 months. * Angle closure glaucoma or its precipitation (narrow angle). * Mycotic, other skin infections and other dermal disorder including infection at anticipated application sites in either axilla. * Any condition or situation that, in the investigator's or sub-investigator's opinion, may interfere with the patient's participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of the Steady State systemic Levels of glycopyrronium | Day-1, Day 1 to Day 13, Day 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BP | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | mmHg |
| Respiratory rate | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | breaths per minute |
| Temperature | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | °C |
| Heart rate | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | bpm |
| 12-lead ECG | Screening, Day 1-13 of study period 1 and period 2 | beats per minute \[bpm\], PR, QRS, QT, QTc, QTcF, and QTcB interval |
| Physical examination | Screening, Day -1, Day 16 | General appearance; eyes; ears, nose and throat; head and neck; chest and lungs; cardiovascular; Abdomen; musculoskeletal; lymphatic; dermatological; neurological and extremities |
| Local tolerability | Day -1, Day 1-13, Day 16 of study period 1 and period 2 | Dermal Evaluation of erythema, edema and papules |
| Systemic pharmacokinetic profile of glycopyrronium at steady state (Area under the drug concentration time curve (AUC)) | Day -1, Day 1 to 13, Day 16 | — |
| Sweat production by gravimetric measurement | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | 5-minute measurement \[filter paper\] interval first without then repeated with an immediately preceded subject consumption of 250 mL of hot water swallowed within 1 minute |
| Systemic pharmacokinetic profile of glycopyrronium at steady state (Time to CMax (Tmax)) | Day -1, Day 1 to 13, Day 16 | — |
| Systemic pharmacokinetic profile of glycopyrronium at steady state (Elimination half-life (t1/2)) | Day -1, Day 1 to 13, Day 16 | — |
| Adverse events (AEs) | Day -1 of study period 1 to Day 16 | — |
| Clinical chemistry | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | Albumin, alkaline phosphatase, ALT, AST, BUN, calcium, chloride, CO2, creatinine, direct bilirubin, GGT, glucose, LDH (lactate dehydrogenase), phosphorus, potassium, sodium, total bilirubin, total cholesterol, total protein, uric acid |
| Hematology | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | Hematocrit, hemoglobin, red blood cell (RBC) count, white blood cell (WBC) count, differentials (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), platelet count, and reticulocytes |
| Urinalysis | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | Color, specific gravity, pH, glucose, ketones, protein, bilirubin, urobilinogen, WBCs, RBCs, and microscopy |
| Hyperhidrosis Disease Severity Scale (HDSS) | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | The Hyperhidrosis Disease Severity Scale (HDSS) is a disease-specific, quick, and easily-understood diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS is a four item scale. A score of 1 or 2 indicates mild or moderate Hyperhidrosis. A score of 3 or 4 indicates severe Hyperhidrosis. |
| Hyperhidrosis Quality of Life Questionnaire (HydroQoL) | Day -1, Day 1 to 13 of period 1 and period 2 | Hyperhidrosis Quality of Life Questionnaire (HydroQoL) is an 18-item, validated, Patient reported Outcome Hyperhidrosis Quality of life Instrument. It is devided into 2 Domains: A Daily Life Activities Domain (6 items) and a Psychosocial Domain (12 items). The items are scored on a 3-point scale (0=no, not at all, 1=a Little, 2=very much). |
| Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax)) | Day -1, Day 1 to 13, Day 16 | — |
Outcome results
None listed