Primary Axillary HyperhidrosisPhase 1NCT03037788

Investigation of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in Subjects With Axillary Hyperhidrosis

A Phase 1 study testing WO3979, WO3970 and WO3992 in people with Primary Axillary Hyperhidrosis, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis. 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?: WO3979, WO3970 and WO3992
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteGermany
Study dates: Nov 2016to Jul 2017
Phase: Phase 1
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 moderate to severe primary axillary hyperhidrosis whose HDSS score is 2, 3 or 4
At least 50 mg in males or 25 mg in females of spontaneous resting axillary sweat production in one axilla measured gravimetrically at room temperature/humidity (about 25°C / 20-50%) over a period of 5 minutes.
Male and female subjects in the age of 18 to 65 years at the time of informed consent and a body mass index (BMI) of 18-32 kg/m2.
Corrected QT (QTc) ≤450 msec, or QTc <480 msec in subjects with bundle branch block.
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 9 months.
Present or history of neuromuscular disease.

Show all 13Show fewer

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.
Significant cardiac arrhythmia such as tachycardiac atrial fibrillation and very frequent extrasystoles.
Subject with diabetes mellitus.
Subjects with ileus, gastrointestinal stenosis, pronounced chronic inflammatory bowel disease, toxic megacolon.
Subjects with epilepsy.
Use of antiperspirants containing aluminium chloride and deodorants, any oral herbal medicine treatments or any other topical treatments for hyperhidrosis within 7 days prior to study treatment.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Nuvisan GmbH
Neu-Ulm, 89231

Other trials in Germany

About this study

Official title: Pharmacokinetics, Local and Systemic Tolerability and Local Efficacy of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in a Placebo Controlled, Double Blind Study in Subjects With Axillary Hyperhidrosis

The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.

Conditions: Primary Axillary Hyperhidrosis
Being tested: WO3979, WO3970, WO3992, 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.

WO3979Drug
Application of cream to each axilla
WO3970Drug
Application of cream to each axilla
WO3992Drug
Application of cream to each axilla
Placebo (WO3988)Drug
Application of cream to each axilla

Study groups in NCT03037788
Study group	Role	What they receive
WO3979	Experimental	Formulation containing WO3979 for topical application Receives: Drug: WO3979
WO3970	Experimental	Formulation containing WO3970 for topical application Receives: Drug: WO3970
WO3992	Experimental	Formulation containing WO3992 for topical application Receives: Drug: WO3992
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.

Tolerability and safety assessed through adverse events and local skin reactions
Measured: 3 weeks

Secondary outcomes (3)

Gravimetric measurement of sweat production
Measured: 3 weeks
Dermatology Life Quality Index (DLQI)
Measured: 3 weeks
Hyperhidrosis Disease Severity Scale (HDSS)
Measured: 3 weeks

Timeline

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

Nov 2016Jul 2017

First posted31 Jan 2017 (estimated)
Study startNov 2016
Primary completionJun 2017
Study completionJul 2017

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03037788
Sponsor's protocol ID: Hyp-02/2015
Other IDs: 2015-005570-38, 2015
Status last verified: Jul 2017
First submitted: 21 Dec 2016
Last updated: 8 Apr 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Local and Systemic Tolerability and Local Efficacy of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in a Placebo Controlled, Double Blind Study in Subjects With Axillary Hyperhidrosis
ClinicalTrials.gov ID: NCT03037788
Acronym / sponsor ID: Hyp-02/2015
Conditions: Primary Axillary Hyperhidrosis
Keywords: Excessive sweating
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
Collaborators: Nuvisan GmbH, FGK Clinical Research GmbH, Charles River Biopharmaceutical Services GmbH
Study start: Nov 2016 (actual)
Primary completion: Jun 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 31 Jan 2017 (estimated)
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 the study is to assess the safety, tolerability, pharmacokinetics (PK) and efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
WO3979	Experimental	Drug: WO3979Formulation containing WO3979 for topical application
WO3970	Experimental	Drug: WO3970Formulation containing WO3970 for topical application
WO3992	Experimental	Drug: WO3992Formulation containing WO3992 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 (6 listed)

Diagnosis of moderate to severe primary axillary hyperhidrosis whose HDSS score is 2, 3 or 4
At least 50 mg in males or 25 mg in females of spontaneous resting axillary sweat production in one axilla measured gravimetrically at room temperature/humidity (about 25°C / 20-50%) over a period of 5 minutes.
Male and female subjects in the age of 18 to 65 years at the time of informed consent and a body mass index (BMI) of 18-32 kg/m2.
Corrected QT (QTc) ≤450 msec, or QTc <480 msec in subjects with bundle branch block.
Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol subjects.

Key exclusion criteria (13 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 9 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
WO3979Application of cream to each axilla	Drug	WO3979
WO3970Application of cream to each axilla	Drug	WO3970
WO3992Application of cream to each axilla	Drug	WO3992
Placebo (WO3988)Application of cream to each axilla	Drug	Placebo of WO3988

Primary outcome

Tolerability and safety assessed through adverse events and local skin reactions
Time frame: 3 weeks

3 secondary outcomes

Gravimetric measurement of sweat production
Time frame: 3 weeks
Dermatology Life Quality Index (DLQI)
Time frame: 3 weeks
Hyperhidrosis Disease Severity Scale (HDSS)
Time frame: 3 weeks

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 8 Apr 2020.
Individual participant dataSharing planned: No

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. Christoph Abels, MD, PhD study director

Dr. August Wolff GmbH & Co. KG Arzneimittel

Horst Jürgen Heuer, MD principal investigator

Nuvisan GmbH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing WO3979, WO3970 and WO3992 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 6 inclusion and 13 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 8 Apr 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Tolerability and safety assessed through adverse events and local skin reactions (time frame: 3 weeks). 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 NCT03037788.

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 8 Apr 2020.