NCT03037788

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 8, 2020

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

December 21, 2016

Last Update Submit

April 7, 2020

Conditions

Primary Axillary Hyperhidrosis

Keywords

Excessive sweating

Outcome Measures

Primary Outcomes (1)

  • Tolerability and safety assessed through adverse events and local skin reactions

    3 weeks

Secondary Outcomes (3)

  • Gravimetric measurement of sweat production

    3 weeks

  • Dermatology Life Quality Index (DLQI)

    3 weeks

  • Hyperhidrosis Disease Severity Scale (HDSS)

    3 weeks

Study Arms (4)

WO3979

EXPERIMENTAL

Formulation containing WO3979 for topical application

Drug: WO3979

WO3970

EXPERIMENTAL

Formulation containing WO3970 for topical application

Drug: WO3970

WO3992

EXPERIMENTAL

Formulation containing WO3992 for topical application

Drug: WO3992

Placebo of WO3988

PLACEBO COMPARATOR

Formulation containing Placebo of WO3988 for topical application

Drug: Placebo (WO3988)

Interventions

WO3979DRUG

Application of cream to each axilla

WO3979
WO3970DRUG

Application of cream to each axilla

WO3970
WO3992DRUG

Application of cream to each axilla

WO3992
Placebo (WO3988)DRUG

Application of cream to each axilla

Placebo of WO3988

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, 89231, Germany

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Prof. Christoph Abels, MD, PhD

    Dr. August Wolff GmbH & Co. KG Arzneimittel

    STUDY DIRECTOR

  • Horst Jürgen Heuer, MD

    Nuvisan GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 31, 2017

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

April 8, 2020

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)