Study on the Effects of Tiotropium Bromide Gel for Patients with Severe Hand Sweating

2 1

What is this study about?

This clinical trial is focused on studying a condition known as severe primary hand hyperhidrosis, which is characterized by excessive sweating of the hands. The trial will evaluate a new topical treatment called Victorhy, which contains the active ingredient tiotropium bromide monohydrate. This treatment is applied as a gel to the skin. The purpose of the study is to assess how effective and safe this gel is for people with this condition.

Participants in the study will be randomly assigned to receive either the Victorhy gel or a placebo gel, which does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The treatment period will last for 28 days, during which participants will apply the gel to their hands as directed. The study will measure changes in sweat production and assess any side effects or skin reactions.

Throughout the study, participants’ quality of life will also be evaluated using questionnaires designed to understand how the condition and treatment affect daily living. The study aims to provide valuable information on whether Victorhy can effectively reduce excessive hand sweating and improve the quality of life for those affected by severe primary hand hyperhidrosis.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your willingness to participate.

You must be at least 18 years old and have a diagnosis of severe primary hand hyperhidrosis for at least six months.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes a sweat production test, where the amount of sweat produced by your palms will be measured.

You will also be asked to discontinue any current treatment for hyperhidrosis.

3 randomization and treatment

You will be randomly assigned to receive either the new treatment, Victorhy, or a placebo. Neither you nor the study team will know which treatment you are receiving.

The treatment involves applying a gel containing tiotropium bromide monohydrate to your hands. The gel is applied topically, meaning it is applied directly to the skin.

4 treatment duration

The treatment will last for 29 days. During this period, you will apply the gel as instructed by the study team.

You will be required to visit the study site for regular check-ups and assessments.

5 end of treatment assessment

At the end of the 29-day treatment period, your sweat production will be measured again to assess the effectiveness of the treatment.

You will also complete questionnaires to evaluate any changes in your quality of life.

6 follow-up visit

A follow-up visit will be scheduled for day 35 to monitor any changes in your condition and to ensure your safety.

During this visit, any side effects or adverse reactions will be recorded and assessed.

Who Can Join the Study?

Sign an informed consent form, which means you agree to participate after understanding the study details.
Be 18 years of age or older.
Be willing to follow the study rules and procedures.
Be a male or a female who is not pregnant or breastfeeding. Females who can have children must have a negative urine pregnancy test.
Have a diagnosis of primary hand hyperhidrosis for at least 6 months. This means excessive sweating of the hands not caused by another condition.
Have a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 at the start of the study. This scale measures how much sweating affects your daily life.
Have a gravimetric test showing at least 100 mg of sweat produced at rest in each palm, and a total of at least 250 mg in both palms in 5 minutes at room temperature. Alternatively, be on a waiting list for a surgery called sympathectomy.
Be willing to stop your current treatment for primary hyperhidrosis during the study.
If you are a woman or man who can have children, agree to use birth control methods from the time you sign the consent form until the last study visit (day 35).

Who Cannot Join the Study?

Patients with any other serious medical conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have allergies to the study medication or its ingredients.
Patients who are currently participating in another clinical trial.
Patients who have used any experimental drugs within the last 30 days.
Patients with a history of substance abuse or alcohol dependency.
Patients who are unable to comply with the study procedures or follow-up visits.
Patients with mental health conditions that might affect their ability to participate.
Patients who have had a major surgery within the last 3 months.
Patients with uncontrolled high blood pressure or heart disease.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Vithas Hospital Nosa Senora De Fatima	Vigo	Spain
Hospital Vithas Parque San Antonio	Malaga	Spain
Hospital Pardo De Aravaca S.A.	Madrid	Spain
Hjweilrs Szpnl Ccxusdqa Iuo	Salt	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	02.11.2023

Trial locations

Investigated drugs:

Tiotropium Bromide Monohydrate

Victorhy is a topical gel used in this clinical trial to help manage severe hand sweating, a condition known as hyperhidrosis. The gel is applied directly to the skin of the hands. It works by reducing the activity of the sweat glands, which helps to decrease the amount of sweat produced. This can help improve comfort and quality of life for people who experience excessive sweating in their hands.

Tiotropium bromide gel is another topical treatment being tested in this trial. It is applied to the skin and is designed to help reduce excessive sweating in the hands. Tiotropium bromide works by blocking certain signals in the body that trigger the sweat glands, thereby reducing the amount of sweat produced. This can help people with severe hand sweating feel more comfortable and less self-conscious about their condition.

Investigated diseases:

Hyperhidrosis

Severe primary hand hyperhidrosis – This condition is characterized by excessive sweating of the hands, which is not caused by external factors such as heat or exercise. It typically begins in childhood or adolescence and can persist throughout life. The excessive sweating is due to overactivity of the sweat glands in the hands, often triggered by stress or nervousness. The condition can lead to significant discomfort and social embarrassment, affecting daily activities and quality of life. The sweating can occur at any time, regardless of the temperature or emotional state, and is often unpredictable. Over time, the constant moisture can lead to skin problems, such as maceration or infections.

Trial ID:

2023-507114-27-00

Protocol code:

Dry002-FiH

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effects of Tiotropium Bromide Gel for Patients with Severe Hand Sweating

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?