Assessment of Safety, Tolerability and Efficacy of 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% Under Maximum-Use Conditions in Subjects with Primary Axillary Hyperhidrosis
- Conditions
- Primary Axillary Hyperhidrosis
- Interventions
- Registration Number
- NCT04159610
- Lead Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description WO 3970 WO3970 Formulation containing WO 3970 for topical application Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
- Primary Outcome Measures
Name Time Method Measurement of the Steady State systemic Levels of glycopyrronium Day-1, Day 1 to Day 13, Day 16
- Secondary Outcome Measures
Name Time Method Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax)) Day -1, Day 1 to 13, Day 16 Systemic pharmacokinetic profile of glycopyrronium at steady state (Area under the drug concentration time curve (AUC)) Day -1, Day 1 to 13, Day 16 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
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
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
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).