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

D

Dr. August Wolff

Status and phase

Not yet enrolling
Phase 2

Conditions

Primary Axillary Hyperhidrosis

Treatments

Drug: WO3970
Drug: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use

Study type

Interventional

Funder types

Industry

Identifiers

NCT04159610
GPBBr-02/2019

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 2 patient groups

WO 3970
Experimental group
Description:
Formulation containing WO 3970 for topical application
Treatment:
Drug: WO3970
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Active Comparator group
Description:
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Treatment:
Drug: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use

Trial contacts and locations

0

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Central trial contact

Clarissa Masur, PhD; Sören Merker, PhD

Data sourced from clinicaltrials.gov

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