Primary Axillary Hyperhidrosis
Conditions
Keywords
Excessive sweating
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.
Interventions
DRUGWO3970
Application of cream to each axilla
DRUGPlacebo (WO3988)
Application of cream to each axilla
Sponsors
Dr. August Wolff GmbH & Co. KG Arzneimittel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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 |
|---|---|
| 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. | Baseline (Day 1a), Day 29 |
| Long-term part (only for newly recruited patients): Absolute change in sweat production assessed by GM from Baseline (Day 1b) to Week 12 | Baseline (Day 1b), Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 29 | 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. |
| 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 | Day 29 | — |
| Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12 | Week 12 | — |
| 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 | Week 4, Week 12 | — |
Countries
Germany
Outcome results
None listed