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

NCT04159610 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: GPBBr-02/2019
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Axillary Hyperhidrosis

Keywords

Excessive sweating

Outcome Measures

Primary Outcomes (1)

• Measurement of the Steady State systemic Levels of glycopyrronium

  Day-1, Day 1 to Day 13, Day 16

Secondary Outcomes (18)

• Systemic pharmacokinetic profile of glycopyrronium at steady state (Area under the drug concentration time curve (AUC))

  Day -1, Day 1 to 13, Day 16

• Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax))

  Day -1, Day 1 to 13, Day 16

• Systemic pharmacokinetic profile of glycopyrronium at steady state (Time to CMax (Tmax))

  Day -1, Day 1 to 13, Day 16

• Systemic pharmacokinetic profile of glycopyrronium at steady state (Elimination half-life (t1/2))

  Day -1, Day 1 to 13, Day 16

• Adverse events (AEs)

  Day -1 of study period 1 to Day 16

Study Arms (2)

WO 3970

EXPERIMENTAL

Formulation containing WO 3970 for topical application

Drug: WO3970

Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use

ACTIVE COMPARATOR

Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use

Drug: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use

Interventions

WO3970 DRUG

Application of cream to each axilla

WO 3970

Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use DRUG

Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only

Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Dr. August Wolff GmbH & Co. KG Arzneimittel: lead
• Therapeutics, Inc.: collaborator

MeSH Terms

Conditions

Hyperhidrosis

Interventions

glycopyrronium tosylate; Glycopyrrolate; Textiles

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: November 12, 2019
• Study Start: December 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 24, 2024

Record last verified: 2021-08