Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase 2, randomised, double-blind, vehicle-controlled, dose finding, efficacy, tolerability and safety study of Victorhy in patients with severe hand hyperhidrosis

This study, called 'Victorhy', is a research project for people who suffer from severe sweating in their hands, known as hyperhidrosis. We are testing a new gel to see how well it works, how safe it is, and if different strengths are more effective. Researchers want to find out if the gel significantly reduces sweating and improves people's quality of life. Participants will be given either the new gel or a harmless gel without the active ingredient (a 'placebo'). No one, including the medical team, will know who is getting which gel until the study is over. This helps make sure the results are fair. The study will measure how much sweat is produced before and after using the gel, and how people's daily lives are affected.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Dryox Health S.L., Dryox Health S.L.

Enrolment target

Start

10 Jan 2024

Severe primary hand hyperhidrosis

What is this study about?

This study is investigating a new gel called Victorhy for people who experience severe sweating from their hands. This condition, known as primary hand hyperhidrosis, can be quite bothersome and impact daily activities. The main purpose of this study is to see how well Victorhy works to reduce hand sweating, how safe it is to use, and if different strengths of the gel (0.5% and 0.1%) have different effects.

To make sure the study results are reliable, it's designed in a 'randomised, double-blind' way. This means participants will be randomly chosen to receive either the Victorhy gel at one of the two strengths, or a 'vehicle' gel. The vehicle gel looks and feels just like the Victorhy gel but doesn't contain the active ingredient; it's often called a placebo. Neither you nor the study team will know which gel you are using until the study is complete. This helps to prevent any bias and gives a clearer picture of how effective the actual treatment is.

Throughout the study, researchers will carefully measure how much sweat your hands produce and ask you questions about how your hand sweating affects your daily life and overall well-being. They will also keep a close eye on any side effects or skin reactions. The information gathered will help determine if Victorhy could be a helpful new treatment option for severe hand sweating.

Key takeaways

The study is testing a new gel called Victorhy for severe hand sweating.
It aims to see how well the gel works and how safe it is.
Participants will receive either Victorhy or a 'dummy' gel (placebo).
Sweat levels and quality of life will be measured regularly.
Participation involves clinic visits over about 35 days.
There's a chance of improving your symptoms or experiencing side effects.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome to take part.

You would need to have been diagnosed with severe primary hand hyperhidrosis. This means that you experience very noticeable and disruptive sweating in your hands that is not caused by another medical condition or medication.

Beyond these general requirements, the study team will have more specific criteria to ensure the study is right for you and that the results are as clear as possible. These might include details about your general health and any other medications you are taking.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you experience severe, ongoing sweating in your hands?
Is your hand sweating not caused by another illness or medicine?
Are you able to attend regular clinic appointments for about 5 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would be randomly assigned to one of four groups – either one of the two strengths of the Victorhy gel, a weaker form of the active drug, or a placebo gel (a cream that looks the same but has no active ingredient). You would apply the assigned gel to your hands as instructed.

Throughout the study, you would have several visits to the clinic. At these visits, the study team will measure your sweat production using a special technique, and you'll be asked to fill out questionnaires about how your hand sweating affects your quality of life. They will also check for any skin reactions or other side effects. The study involves measuring how much you sweat on day 1, and again on day 29. After you've finished using the treatment, there will be a follow-up visit on day 35 to see if the improvements are lasting.

The total duration of your active participation in the study would be about 35 days, including the treatment period and follow-up.

Potential risks and benefits

By taking part in this study, you might benefit from a reduction in your hand sweating if the Victorhy gel is effective. You would also be contributing important information that could help others with severe hand hyperhidrosis in the future. However, there's no guarantee that you will receive the active treatment or that it will work for you. Potential risks might include skin irritation or other side effects from the gel, which the study team will monitor closely. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is 'hand hyperhidrosis'?

Hand hyperhidrosis means you have very sweaty hands, which can be constant and not just related to heat or exercise. It's a medical condition.

What does 'double-blind' mean in a study?

It means that neither you nor the doctors treating you will know whether you are receiving the new gel or the inactive (placebo) gel. This helps to make the study results fair and accurate.

Will I have to pay to be in this study?

No, you will not have to pay for the study treatment or for any of the study-related visits or tests.

What if I experience side effects?

The study team will carefully monitor you for any side effects or skin reactions. You should report any concerns immediately to them.

How long will the treatment period last?

The main treatment period involves using the gel regularly up to day 29, with a follow-up visit on day 35.