Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A bioequivalence vasoconstriction study comparing two clobetasol propionate 0.5 mg/g ointments after skin application in healthy adult human subjects

This research is a 'bioequivalence' study, which means we're checking if two different strong skin ointments, both containing clobetasol propionate, have the same effect on the body when applied to the skin. This particular type of ointment is used for skin problems that are hard to treat and cause a lot of inflammation, like certain types of eczema or psoriasis. The study involves healthy adult volunteers, and the main goal is to make sure that a new version of the ointment works just as well as an existing one. This helps ensure that patients always get reliable and effective treatment for their skin conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

BELUPO lijekovi i kozmetika d.d.

Enrolment target

100

Start

11 Sep 2023

Localized, therapy-resistant inflammatory skin diseases, for which the use of topical corticosteroids with very high potency is indicated.

What is this study about?

This study is about a very strong skin cream called clobetasol propionate, which is used for skin conditions that are really stubborn and cause a lot of redness and swelling (inflammation). Think of it like comparing two different brands of the same medication to see if they do exactly the same job.

The main idea behind this study is to check if two versions of this clobetasol propionate ointment are 'bioequivalent'. This scientific term simply means making sure that when you put them on your skin, they have the same strength and effect on your body. Imagine if you had a favourite painkiller and a new, cheaper version came out – this study is like making sure the new one works just as well as your usual one.

Why does this matter? Well, for people living with tricky skin conditions, having effective and reliable medication is really important. By doing these comparisons, scientists can ensure that any new or generic versions of powerful skin creams are just as good as the original, so patients can continue to get the best possible treatment for their very inflamed skin.

Key takeaways

This study compares two strong skin creams.
It aims to ensure they work equally well.
It involves healthy adult volunteers (18+).
It helps guarantee reliable skin treatments.
Participation includes applying cream and skin checks.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. We welcome both men and women to take part.

The study is specifically looking for healthy people, not those with existing skin conditions. This is because we want to see how the cream works on typical skin without any other issues affecting the results. This helps us get a clear picture of how the two ointments compare.

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 generally healthy?
Do you understand this study is comparing two creams?
Are you willing to follow study instructions for applying cream?
Can you attend clinic visits as required?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll apply small amounts of the ointment to your skin. Doctors will then check how your blood vessels react to the cream, which is a way of measuring its strength and how well it's working. This usually involves some skin measurements or samples.

You might need to visit the clinic a few times over a short period. The exact number of visits and tests will be explained to you in detail. There won't be any long-term follow-up beyond the study period, as its main aim is to compare how two creams work in healthy people. The total time you'd spend taking part in the study would be quite short, usually over a few days or weeks.

Potential risks and benefits

Taking part in a study like this helps us learn more about medicines, which can eventually benefit many patients. You might not directly benefit from this particular study, as it's about comparing two existing treatments. Potential temporary side effects from using strong skin ointments include mild skin irritation, redness, or thinning of the skin where the cream is applied. These effects are usually mild and temporary. 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
Poland

Common questions

What does a 'bioequivalence' study mean?

It means the study is checking if two different versions of the same medicine (like two brands of strong skin cream) work in the exact same way once they are applied.

Who is this clobetasol propionate ointment for?

It's a very strong cream used to treat long-lasting, severe skin problems that cause a lot of redness and swelling, which haven't responded to weaker treatments.

Will I get this medicine for my own skin condition?

No, this study is for healthy volunteers to compare two ointments. If you have a skin condition, please talk to your doctor about your treatment options.

What will happen during the study?

You'll apply small amounts of both creams to your skin, and we'll check how your body responds, usually by looking at changes in your skin.

Is clobetasol propionate a strong medicine?

Yes, it is considered a very potent (strong) steroid cream and is usually prescribed for difficult-to-treat skin conditions under a doctor's supervision.