In short
There is currently 1 ongoing clinical trial investigating new treatments for hyperhidrosis, a condition characterised by excessive sweating. This trial is evaluating a topical gel treatment for severe hand sweating and is being conducted in Spain.
Clinical trial locations
Study on the Effects of Tiotropium Bromide Gel for Patients with Severe Hand Sweating
This clinical trial focuses on severe primary hand hyperhidrosis, a condition where the hands produce excessive amounts of sweat. The study is testing a new topical gel treatment called Victorhy, which contains the active ingredient tiotropium bromide monohydrate.
Main inclusion criteria:
- Participants must be at least 18 years old
- Must have been diagnosed with primary hand hyperhidrosis for at least 6 months
- Must have a Hyperhidrosis Disease Severity Scale score of 3 or 4, indicating that sweating significantly affects daily life
- Must produce at least 100 mg of sweat in each palm (or at least 250 mg total in both palms) during a 5-minute resting period
- Must be willing to stop any current treatment for excessive sweating during the study
- Women who can have children must agree to use birth control throughout the study and have a negative pregnancy test
Main exclusion criteria:
- People with serious medical conditions that could interfere with the study
- Pregnant or breastfeeding women
- People with allergies to the study medication or its ingredients
- People currently participating in another clinical trial or who have used experimental drugs within the last 30 days
- People with a history of substance abuse or alcohol dependency
- People with mental health conditions that might affect their ability to participate
- People who have had major surgery within the last 3 months
- People with uncontrolled high blood pressure or heart disease
Study focus and design:
The trial is designed as a double-blind study, meaning neither participants nor researchers will know who is receiving the actual treatment (Victorhy gel) or a placebo gel during the 28-day treatment period. This design helps ensure the results are unbiased. The gel is applied directly to the skin of the hands as directed.
Throughout the study, researchers will measure changes in sweat production and assess any side effects or skin reactions. Participants will also complete questionnaires to understand how the condition and treatment affect their quality of life and daily activities.
Investigational drugs:
The study is testing Victorhy, a topical gel containing tiotropium bromide monohydrate. This medication belongs to a class of drugs called anticholinergics, which work by blocking certain signals in the body that trigger the sweat glands. By reducing the activity of these glands, the gel aims to decrease the amount of sweat produced in the hands, potentially improving comfort and reducing the social embarrassment often associated with excessive hand sweating.
Summary
Currently, there is one active clinical trial available for people living with severe primary hand hyperhidrosis. This trial is being conducted in Spain and focuses on evaluating a new topical treatment approach using tiotropium bromide gel. The study aims to provide valuable information on whether this medication can effectively reduce excessive hand sweating and improve quality of life for those affected by this condition. The trial uses a rigorous double-blind design to ensure reliable results and includes comprehensive assessments of both effectiveness and safety over a one-month treatment period.
