Primary Axillary HyperhidrosisPhase 3NCT03658616
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.
A Phase 3 study testing WO3970 in people with Primary Axillary Hyperhidrosis, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Axillary Hyperhidrosis
- What is being tested?
- WO3970
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 518 participants
- Where
- 1 siteGermany
- Study dates
- 18 Sep 2018to 2 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Primary Axillary Hyperhidrosis
- Being tested
- WO3970, Placebo (WO3988)
- Keywords
- Excessive sweating
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WO3970Drug
Application of cream to each axilla
Placebo (WO3988)Drug
Application of cream to each axilla
| Study group | Role | What they receive |
|---|---|---|
| WO3970 | Experimental | Formulation containing WO3979 for topical application Receives: Drug: WO3970 |
| Placebo of WO3988 | Placebo comparator | Formulation containing Placebo of WO3988 for topical application Receives: Drug: Placebo (WO3988) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline (Day 1b), Week 12
Secondary outcomes (4)
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
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.
Measured: Day 29
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
Measured: Day 29
Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12
Measured: 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
Measured: Week 4, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start18 Sep 2018
- Primary completion2 Nov 2021
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Axillary HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Rolf-Markus Szeimies, MD, Principal investigator, Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658616
- Sponsor's protocol ID
- Hyp1-18/2016
- Status last verified
- Apr 2023
- First submitted
- 3 Sep 2018
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Donhauser T, Apfelbacher C, Kann G, Masur C, Kamudoni P, Salek S, Abels C, Gabes M. Hyperhidrosis quality of life index (HidroQoL): further validation by applying classical test theory and item response theory using data from a phase III clinical trial. J Patient Rep Outcomes. 2023 Jun 6;7(1):55. doi: 10.1186/s41687-023-00596-6.
PubMed 37280417
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03658616
- Acronym / sponsor ID
- Hyp1-18/2016
- Conditions
- Primary Axillary Hyperhidrosis
- Keywords
- Excessive sweating
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WO3970 | Experimental | Drug: WO3970Formulation containing WO3979 for topical application |
| Placebo of WO3988 | Placebo comparator | Drug: Placebo (WO3988)Formulation containing Placebo of WO3988 for topical application |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WO3970Application of cream to each axilla | Drug | WO3970 |
| Placebo (WO3988)Application of cream to each axilla | Drug | Placebo of WO3988 |
Primary outcome
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.
Time frame: 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
Time frame: Baseline (Day 1b), Week 12
4 secondary outcomes
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
Time frame: Day 29
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
Time frame: Day 29
Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12
Time frame: 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
Time frame: Week 4, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Derived from this study: PubMed 37280417Donhauser T, Apfelbacher C, Kann G, Masur C, Kamudoni P, Salek S, Abels C, Gabes M. Hyperhidrosis quality of life index (HidroQoL): further validation by applying classical test theory and item response theory using data from a phase III clinical trial. J Patient Rep Outcomes. 2023 Jun 6;7(1):55. doi: 10.1186/s41687-023-00596-6.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Rolf-Markus Szeimies, MD principal investigator
Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing WO3970 in people with Primary Axillary Hyperhidrosis, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline (Day 1a), Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03658616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.