Clinical trial NCT03658616: Assessment of Efficacy and Safety of Topical Administration of 1% Glycopyrronium Bromide (GPB) 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.
Official title: Combined Randomized, Double-blind, Dose-confirming Phase 3a Study in Parallel Design to Assess the Efficacy and Safety of Topical 4-week Treatment With 1% GPB Cream vs Placebo and Open-label Phase 3b Study to Assess Long-term Efficacy and Safety in Patients With Primary Axillary Hyperhidrosis Treated With 1% GPB Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Axillary Hyperhidrosis
Keywords: Excessive sweating
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
First posted: 2018-09-05
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the efficacy and safety of 1% GPB cream after 4 weeks of treatment compared with placebo with a sufficient number of patients to obtain statistically significant results, and to assess the long-term safety of 1% GPB cream.


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: Dose-confirming part: 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.
timeFrame: Baseline (Day 1a), Day 29
measure: Long-term part (only for newly recruited patients): Absolute change in sweat production assessed by GM from Baseline (Day 1b) to Week 12
timeFrame: Baseline (Day 1b), Week 12
Secondary outcomes:
measure: Dose-confirming part: Percentage of responders assessed by the Hyperhidrosis Disease Severity Scale (HDSS) (≥2-point improvement from Baseline) on Day 29 in the 1% GPB group compared with the placebo group
timeFrame: Day 29
measure: Dose-confirming part: 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
timeFrame: Day 29
measure: Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12
timeFrame: Week 12
measure: Long-term part: Percentage of responders assessed by GM at Week 4 and Week 12 (defined by sweat reduction of ≥50%, ≥75%, and ≥90% compared with Baseline
timeFrame: Week 4, Week 12
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Dr. Harald Brüning
Study officials:
affiliation: Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
name: Prof. Rolf-Markus Szeimies, MD
role: PRINCIPAL_INVESTIGATOR
References: