Clinical trial NCT04159610: 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
Official title: A Randomized, Open-Label, Multiple Dose, Two-Period Crossover Study Evaluating Maximum Use 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% in Men and Women with Primary Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Primary Axillary Hyperhidrosis
Keywords: Excessive sweating
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
Collaborators: name: Therapeutics, Inc.
First posted: 2019-11-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of the Steady State systemic Levels of glycopyrronium
timeFrame: Day-1, Day 1 to Day 13, Day 16
Secondary outcomes:
measure: Systemic pharmacokinetic profile of glycopyrronium at steady state (Area under the drug concentration time curve (AUC))
timeFrame: Day -1, Day 1 to 13, Day 16
measure: Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax))
timeFrame: Day -1, Day 1 to 13, Day 16
measure: Systemic pharmacokinetic profile of glycopyrronium at steady state (Time to CMax (Tmax))
timeFrame: Day -1, Day 1 to 13, Day 16
measure: Systemic pharmacokinetic profile of glycopyrronium at steady state (Elimination half-life (t1/2))
timeFrame: Day -1, Day 1 to 13, Day 16
measure: Adverse events (AEs)
timeFrame: Day -1 of study period 1 to Day 16
measure: Clinical chemistry
timeFrame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
measure: Hematology
timeFrame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
measure: Urinalysis
timeFrame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
measure: BP
timeFrame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
measure: Respiratory rate
timeFrame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
measure: Temperature
timeFrame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
measure: Heart rate
timeFrame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
measure: 12-lead ECG
timeFrame: Screening, Day 1-13 of study period 1 and period 2
measure: Physical examination
timeFrame: Screening, Day -1, Day 16
measure: Local tolerability
timeFrame: Day -1, Day 1-13, Day 16 of study period 1 and period 2
measure: Sweat production by gravimetric measurement
timeFrame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
measure: Hyperhidrosis Disease Severity Scale (HDSS)
timeFrame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
measure: Hyperhidrosis Quality of Life Questionnaire (HydroQoL)
timeFrame: Day -1, Day 1 to 13 of period 1 and period 2
Other outcomes:
Locations:
Study officials:
References: