Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Assessment of narrowing of blood vessels after single application of two clascoterone formulations (cream and solution) onto the skin in comparison to three marketed topical corticosteroids

This research is testing two new skin treatments known as clascoterone, one as a cream and one as a liquid solution. We want to see how these new treatments affect tiny blood vessels in the skin. Specifically, we'll be checking if they cause the blood vessels to become narrower. This is a common test used to understand how strong a skin treatment is, especially when compared to well-known steroid creams. The study aims to make sure these new treatments are safe and to understand how they work in the body, which helps doctors decide how and when to use them for skin conditions. People aged 18 and over can take part, regardless of their gender.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Cassiopea S.p.A.

Enrolment target

Start

29 Jan 2024

Test of vasocontriction properties for classification of topical steroid potency

What is this study about?

Imagine you have a skin condition, and your doctor prescribes a cream. This study is like a very early test for new creams called clascoterone. We're looking at how these creams affect the tiny blood vessels in your skin. When some skin creams are applied, they can make these blood vessels narrower. This effect, where blood vessels constrict or get smaller, is a standard way that scientists check how powerful a cream is, especially for conditions like eczema or psoriasis where reducing inflammation is key.

Think of it this way: some powerful creams are known to make blood vessels really narrow, while milder ones might have less of an effect. By observing how clascoterone cream and solution affect blood vessels, we can compare them to existing steroid creams that doctors already use. This helps us understand if clascoterone might work in a similar way or how strong it might be.

The main goal is to gather important information about how these new clascoterone treatments interact with the body, specifically the skin. This early research helps doctors and scientists understand the treatments better and is a crucial step before they can be used more widely. It provides valuable insights into their potential benefits and how they might be used to help people with various skin problems in the future.

Key takeaways

This study evaluates new skin treatments called clascoterone (cream and solution).
It compares their effects on skin blood vessels to existing steroid creams.
The goal is to understand how strong and effective these new treatments might be.
Anyone 18 years or older, male or female, can participate.
Participation involves applying treatments to the skin and having measurements taken.

Who may be eligible?

This study is open to anyone aged 18 years or older. There is no upper age limit, meaning both younger adults and older individuals are welcome to take part.

Both men and women can participate in this research. The study is designed to include people of all genders to ensure the findings are as broad as possible.

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?
Are you comfortable having different creams or solutions applied to your skin?
Are you available for potential visits to a clinic or research center?
Are you generally healthy and without major skin conditions that might interfere with the test areas?

Answer every question to see your result.

What does participation involve?

The detailed steps for taking part in this study are not fully described in the information provided. However, typically for this type of early-stage study, you would likely: attend an initial screening visit to check if you're suitable; have the various creams or solutions applied to small areas of your skin; and then have measurements taken to see how your blood vessels react. There would likely be one or more follow-up visits to ensure your skin is reacting as expected and to collect all the necessary data. The study would involve a short-term commitment, potentially lasting a few days or weeks in total, from your first visit to your last follow-up. You would not take any medication internally; the treatments are applied only to your skin.

Potential risks and benefits

Taking part in a study like this could help advance medical knowledge, potentially leading to new treatments for skin conditions in the future. As with any study, there are potential risks, such as mild skin irritation, redness, or a temporary change in skin colour where the creams are applied. However, these are generally expected to be minor, and the study will be supervised by medical professionals. 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
Germany

Common questions

What is clascoterone?

Clascoterone is a new type of medicine being tested for skin conditions. This study is looking at it in both cream and liquid forms.

Why is the study looking at blood vessels?

Checking how creams affect tiny blood vessels helps doctors understand how strong a skin treatment might be, especially compared to existing steroid creams.

Will I have to take any medicine by mouth?

No, the treatments in this study are only applied to the skin, not taken orally.

How long will the study last if I join?

The information doesn't specify an exact duration, but these types of studies usually involve a short-term commitment, possibly a few days or weeks.

Do I have to be a certain gender to join?

No, both men and women are welcome to participate in this study.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.