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Trial record 28 of 166 for:    "Sweat Gland Disease"

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

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ClinicalTrials.gov Identifier: NCT03037788
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : July 14, 2017
Sponsor:
Collaborators:
Nuvisan GmbH
FGK Clinical Research GmbH
Charles River Biopharmaceutical Services GmbH
Information provided by (Responsible Party):
Dr. August Wolff GmbH & Co. KG Arzneimittel

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.

Condition or disease Intervention/treatment Phase
Primary Axillary Hyperhidrosis Drug: WO3979 Drug: WO3970 Drug: WO3992 Drug: Placebo (WO3988) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: WO3979
Formulation containing WO3979 for topical application
Drug: WO3979
Application of cream to each axilla

Experimental: WO3970
Formulation containing WO3970 for topical application
Drug: WO3970
Application of cream to each axilla

Experimental: WO3992
Formulation containing WO3992 for topical application
Drug: WO3992
Application of cream to each axilla

Placebo Comparator: Placebo of WO3988
Formulation containing Placebo of WO3988 for topical application
Drug: Placebo (WO3988)
Application of cream to each axilla




Primary Outcome Measures :
  1. Tolerability and safety assessed through adverse events and local skin reactions [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Gravimetric measurement of sweat production [ Time Frame: 3 weeks ]
  2. Dermatology Life Quality Index (DLQI) [ Time Frame: 3 weeks ]
  3. Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: 3 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037788


Locations
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Germany
Nuvisan GmbH
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Dr. August Wolff GmbH & Co. KG Arzneimittel
Nuvisan GmbH
FGK Clinical Research GmbH
Charles River Biopharmaceutical Services GmbH
Investigators
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Study Director: Prof. Christoph Abels, MD, PhD Dr. August Wolff GmbH & Co. KG Arzneimittel
Principal Investigator: Horst Jürgen Heuer, MD Nuvisan GmbH

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Responsible Party: Dr. August Wolff GmbH & Co. KG Arzneimittel
ClinicalTrials.gov Identifier: NCT03037788     History of Changes
Other Study ID Numbers: Hyp-02/2015
2015-005570-38 ( EudraCT Number )
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. August Wolff GmbH & Co. KG Arzneimittel:
Excessive sweating

Additional relevant MeSH terms:
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Sweat Gland Diseases
Hyperhidrosis
Skin Diseases
Bromides
Glycopyrrolate
Anticonvulsants
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs