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

Launched by DR. AUGUST WOLFF GMBH & CO. KG ARZNEIMITTEL · Nov 7, 2019

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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