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Trial record 16 of 174 for:    "Sweat Gland Disease"

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.

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ClinicalTrials.gov Identifier: NCT03658616
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. August Wolff GmbH & Co. KG Arzneimittel

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Axillary Hyperhidrosis Drug: WO3970 Drug: Placebo (WO3988) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Experimental: WO3970
Formulation containing WO3979 for topical application
Drug: WO3970
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. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
  3. Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12 [ Time Frame: Week 12 ]
  4. 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 ]


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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 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

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 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;

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): NCT03658616


Contacts
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Contact: Clarissa Masur, PhD +49 521 8808 319 clarissa.masur@drwolffgroup.com
Contact: Gisela Straus, PhD +49 (0)89 893 119 34 gisela.straus@fgk-cro.de

Locations
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Germany
Dr. Harald Brüning Recruiting
Kiel, Germany, 24148
Contact: Harald Brüning, MD         
Sponsors and Collaborators
Dr. August Wolff GmbH & Co. KG Arzneimittel
Investigators
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Study Director: Prof. Christoph Abels, MD, PhD Dr. August Wolff GmbH & Co. KG Arzneimittel
Principal Investigator: Prof. Rolf-Markus Szeimies, MD Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

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Responsible Party: Dr. August Wolff GmbH & Co. KG Arzneimittel
ClinicalTrials.gov Identifier: NCT03658616     History of Changes
Other Study ID Numbers: Hyp1-18/2016
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. August Wolff GmbH & Co. KG Arzneimittel:
Excessive sweating
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases