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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

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ClinicalTrials.gov Identifier: NCT04159610
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
Therapeutics, Inc.
Information provided by (Responsible Party):
Dr. August Wolff GmbH & Co. KG Arzneimittel

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Axillary Hyperhidrosis Drug: WO3970 Drug: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : November 1, 2020

Arm Intervention/treatment
Experimental: WO 3970
Formulation containing WO 3970 for topical application
Drug: WO3970
Application of cream to each axilla

Active Comparator: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Drug: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only




Primary Outcome Measures :
  1. Measurement of the Steady State systemic Levels of glycopyrronium [ Time Frame: Day-1, Day 1 to Day 13, Day 16 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax)) [ Time Frame: Day -1, Day 1 to 13, Day 16 ]
  3. Systemic pharmacokinetic profile of glycopyrronium at steady state (Time to CMax (Tmax)) [ Time Frame: Day -1, Day 1 to 13, Day 16 ]
  4. Systemic pharmacokinetic profile of glycopyrronium at steady state (Elimination half-life (t1/2)) [ Time Frame: Day -1, Day 1 to 13, Day 16 ]
  5. Adverse events (AEs) [ Time Frame: Day -1 of study period 1 to Day 16 ]
  6. Clinical chemistry [ Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 ]
    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

  7. Hematology [ Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 ]
    Hematocrit, hemoglobin, red blood cell (RBC) count, white blood cell (WBC) count, differentials (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), platelet count, and reticulocytes

  8. Urinalysis [ Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 ]
    Color, specific gravity, pH, glucose, ketones, protein, bilirubin, urobilinogen, WBCs, RBCs, and microscopy

  9. BP [ Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 ]
    mmHg

  10. Respiratory rate [ Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 ]
    breaths per minute

  11. Temperature [ Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 ]
    °C

  12. Heart rate [ Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 ]
    bpm

  13. 12-lead ECG [ Time Frame: Screening, Day 1-13 of study period 1 and period 2 ]
    beats per minute [bpm], PR, QRS, QT, QTc, QTcF, and QTcB interval

  14. Physical examination [ Time Frame: Screening, Day -1, Day 16 ]
    General appearance; eyes; ears, nose and throat; head and neck; chest and lungs; cardiovascular; Abdomen; musculoskeletal; lymphatic; dermatological; neurological and extremities

  15. Local tolerability [ Time Frame: Day -1, Day 1-13, Day 16 of study period 1 and period 2 ]
    Dermal Evaluation of erythema, edema and papules

  16. Sweat production by gravimetric measurement [ Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 ]
    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

  17. Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 ]
    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.

  18. Hyperhidrosis Quality of Life Questionnaire (HydroQoL) [ Time Frame: Day -1, Day 1 to 13 of period 1 and period 2 ]
    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).



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Ages Eligible for Study:   18 Years and older   (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): NCT04159610


Contacts
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Contact: Clarissa Masur, PhD +49 521 8808 319 clarissa.masur@drwolffgroup.com
Contact: Sören Merker, PhD +49 521 8808 597 soeren.merker@drwolffgroup.com

Sponsors and Collaborators
Dr. August Wolff GmbH & Co. KG Arzneimittel
Therapeutics, Inc.
Investigators
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Study Director: Prof. Christoph Abels, MD, PhD Dr. August Wolff GmbH & Co. KG Arzneimittel
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Responsible Party: Dr. August Wolff GmbH & Co. KG Arzneimittel
ClinicalTrials.gov Identifier: NCT04159610    
Other Study ID Numbers: GPBBr-02/2019
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
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