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.

NCT03658616 | Completed Phase 3 DMC

• 1 other identifier: Hyp1-18/2016
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Axillary Hyperhidrosis

Keywords

Excessive sweating

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (Day 1a), Day 29

• Long-term part (only for newly recruited patients): Absolute change in sweat production assessed by GM from Baseline (Day 1b) to Week 12

  Baseline (Day 1b), Week 12

Secondary Outcomes (4)

• 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

  Day 29

• 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

  Day 29

• Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12

  Week 12

• 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

  Week 4, Week 12

Study Arms (2)

WO3970

EXPERIMENTAL

Formulation containing WO3979 for topical application

Drug: WO3970

Placebo of WO3988

PLACEBO COMPARATOR

Formulation containing Placebo of WO3988 for topical application

Drug: Placebo (WO3988)

Interventions

WO3970 DRUG

Application of cream to each axilla

WO3970

Placebo (WO3988) DRUG

Application of cream to each axilla

Placebo of WO3988

Eligibility Criteria

• Age: 18 Years - 65 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

Study Sites (1)

Dr. Harald Brüning

Kiel, 24148, Germany

Location

Related Publications (1)

• Donhauser T, Apfelbacher C, Kann G, Masur C, Kamudoni P, Salek S, Abels C, Gabes M. Hyperhidrosis quality of life index (HidroQoL): further validation by applying classical test theory and item response theory using data from a phase III clinical trial. J Patient Rep Outcomes. 2023 Jun 6;7(1):55. doi: 10.1186/s41687-023-00596-6.

  PMID: 37280417 DERIVED

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Prof. Rolf-Markus Szeimies, MD

  Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 5, 2018
• Study Start: September 18, 2018
• Primary Completion: November 2, 2021
• Study Completion: February 2, 2022
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

DE (1)