Primary Axillary HyperhidrosisPhase 2NCT04159610

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

A Phase 2 study testing WO3970 and Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use in people with Primary Axillary Hyperhidrosis, run by Dr. August Wolff GmbH & Co. KG Arzneimittel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Axillary Hyperhidrosis
What is being tested?: WO3970 and Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Dec 2019to Oct 2020
Phase: Phase 2
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 years and older
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

About this study

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

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.

Conditions: Primary Axillary Hyperhidrosis
Being tested: WO3970, Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
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
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical useDrug
Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only

Study groups in NCT04159610
Study group	Role	What they receive
WO 3970	Experimental	Formulation containing WO 3970 for topical application Receives: Drug: WO3970
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use	Active comparator	Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use Receives: Drug: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of the Steady State systemic Levels of glycopyrronium
Measured: Day-1, Day 1 to Day 13, Day 16

Secondary outcomes (18)

Systemic pharmacokinetic profile of glycopyrronium at steady state (Area under the drug concentration time curve (AUC))
Measured: Day -1, Day 1 to 13, Day 16
Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax))
Measured: Day -1, Day 1 to 13, Day 16
Systemic pharmacokinetic profile of glycopyrronium at steady state (Time to CMax (Tmax))
Measured: Day -1, Day 1 to 13, Day 16
Systemic pharmacokinetic profile of glycopyrronium at steady state (Elimination half-life (t1/2))
Measured: Day -1, Day 1 to 13, Day 16
Adverse events (AEs)
Measured: Day -1 of study period 1 to Day 16
Clinical chemistry
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
Measured: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Hematology
Hematocrit, hemoglobin, red blood cell (RBC) count, white blood cell (WBC) count, differentials (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), platelet count, and reticulocytes
Measured: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Urinalysis
Color, specific gravity, pH, glucose, ketones, protein, bilirubin, urobilinogen, WBCs, RBCs, and microscopy
Measured: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
BP
mmHg
Measured: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Respiratory rate
breaths per minute
Measured: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Temperature
°C
Measured: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Heart rate
bpm
Measured: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
12-lead ECG
beats per minute [bpm], PR, QRS, QT, QTc, QTcF, and QTcB interval
Measured: Screening, Day 1-13 of study period 1 and period 2
Physical examination
General appearance; eyes; ears, nose and throat; head and neck; chest and lungs; cardiovascular; Abdomen; musculoskeletal; lymphatic; dermatological; neurological and extremities
Measured: Screening, Day -1, Day 16
Local tolerability
Dermal Evaluation of erythema, edema and papules
Measured: Day -1, Day 1-13, Day 16 of study period 1 and period 2
Sweat production by gravimetric measurement
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
Measured: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Hyperhidrosis Disease Severity Scale (HDSS)
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: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Hyperhidrosis Quality of Life Questionnaire (HydroQoL)
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).
Measured: Day -1, Day 1 to 13 of period 1 and period 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2019Oct 2020

First posted12 Nov 2019
Study startDec 2019 (estimated)
Primary completionOct 2020 (estimated)
Study completionOct 2020 (estimated)

Why it stopped: The study was not pursued for internal reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04159610
Sponsor's protocol ID: GPBBr-02/2019
Status last verified: Aug 2021
First submitted: 9 Sep 2019
Last updated: 24 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04159610
Acronym / sponsor ID: GPBBr-02/2019
Conditions: Primary Axillary Hyperhidrosis
Keywords: Excessive sweating
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The study was not pursued for internal reasons
Enrolment: 0 participants (actual)
Lead sponsor: Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
Collaborators: Therapeutics, Inc.
Study start: Dec 2019 (estimated)
Primary completion: Oct 2020 (estimated)
Study completion: Oct 2020 (estimated)
First posted: 12 Nov 2019 (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 safety, tolerability and efficacy of 1% GPB Cream compared to Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use under maximum use conditions.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
WO 3970	Experimental	Drug: WO3970Formulation containing WO 3970 for topical application
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use	Active comparator	Drug: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical useQbrexza® (glycopyrronium) cloth, 2.4%, for topical use

Who may qualify

Ages: 18 years and older
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	WO 3970
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical useQbrexza should be applied to the clean, dry, intact skin, of your underarm areas only	Drug	Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use

Primary outcome

Measurement of the Steady State systemic Levels of glycopyrronium
Time frame: Day-1, Day 1 to Day 13, Day 16

18 secondary outcomes

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

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing WO3970 and Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use in people with Primary Axillary Hyperhidrosis, run by Dr. August Wolff GmbH & Co. KG Arzneimittel.

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: withdrawn, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Measurement of the Steady State systemic Levels of glycopyrronium (time frame: Day-1, Day 1 to Day 13, Day 16). 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 NCT04159610.

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 24 Dec 2024.