Primary Axillary Hyperhidrosis Treated With 1% GPB Cream
Research type
Research Study
Full title
Combined Randomized, Double-Blind, Dose-Confirming Phase 3a Study in Parallel Design to Assess the Efficacy and Safety of Topical 4-Week Treatment With 1% GPB Cream vs Placebo and Open-Label Phase 3b Study to Assess Long-Term Efficacy and Safety in Patients With Primary Axillary Hyperhidrosis Treated With 1% GPB Cream
IRAS ID
247083
Contact name
David Eccleston
Contact email
Sponsor organisation
Dr. August Wolff GmbH & Co. KG Arzneimittel
Eudract number
2017-004534-28
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Summary of Research
Hyperhidrosis is a chronic and distressing dermatologic and neurologic disorder and involves the increased production of sweat. It can be primary (idiopathic) or secondary to other diseases such as metabolic disorders, febrile illnesses, or medication use (e.g. antidepressants).
Dr August Wolff gmbH & Co.KG Arzneimittel have developed a topical Glycopyrronium bromide (GPB) formulation for the treatment of axillary hyperhidrosis.
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.
The study will be conducted at around 25 centres in Germany, Austria, Poland, Hungary, UK, Denmark and Sweden.
This is a combined randomized, double-blind, multi-center, placebo-controlled, dose-confirming Phase 3a study followed by a multi-centre, open-label, long-term Phase 3b study in patients with primary axillary hyperhidrosis. The study comprises a 4-week blinded dose-confirming part during which the efficacy and safety of treatment with 1% GPB cream is compared with treatment with placebo cream. The dose-confirming part is followed by a 72-week, open-label, long-term part during which the long-term safety and efficacy of treatment with 1% GPB cream are assessed for the first 12 weeks of treatment and the long-term safety up until 72 weeks of treatment. A safety follow-up visit is performed 4 weeks after the end of long-term treatment at Week 76. Patients participating in the dose-confirming part have the option to roll over to the long-term part.
Summary of Results
1% GPB cream significantly reduces sweat production in patients with severe underarm sweating (so-called primary axillary hyperhidrosis) after 4 weeks of once-daily treatment;
• The sweat production remains reduced throughout the assessed period (up to Week 12) even when 1% GPB cream could be applied less frequently (with a median of 7 applications per week at Week 4 and 4 applications per week at Week 12)
• 1% GPB cream continuously improves the severity of hyperhidrosis and the patient’s quality of life over a period of up to 72 weeks
• 1% GPB cream is safe and well tolerated
• Out of the side effects that may occur after using a medication of this specific class (a so-called anticholinergic medication), dry mouth is the only observed side effect related to treatment with 1% GPB cream that is reported in over 10% of patients. This side effect was observed after 4 weeks of once-daily treatment with 1% GPB cream, as well as during the studied period (up to Week 72) and with a less frequent application of 1% GPB cream (treatment as needed) after Week 4REC name
East of Scotland Research Ethics Service REC 2
REC reference
18/ES/0083
Date of REC Opinion
8 Aug 2018
REC opinion
Further Information Favourable Opinion