Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A randomized, investigator masked pilot study to establish the experimental conditions and select the criteria to compare topical application of 2 methyl aminolevulinate creams: evaluation of protoporphyrin IX formation in the skin of healthy subjects.

This study is a small, early-stage trial designed to help scientists understand more about how certain skin creams work. The main goal is to compare two different creams that contain a substance called methyl aminolevulinate. Researchers will apply these creams to the skin of healthy volunteers and then measure how much of a natural chemical, called protoporphyrin IX, forms in the skin. This chemical is important for some skin treatments. The information gathered from this study will help researchers decide the best way to test these creams in the future and choose the right measurements to use. It's a foundational step to fine-tune experimental methods for future, larger studies.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Substipharm

Enrolment target

Start

25 Jul 2024

None - Healthy subjects

What is this study about?

Imagine scientists are trying to figure out the best way to measure how a new cream works on your skin. That's essentially what this study is doing. They're testing two different versions of a cream containing a substance called methyl aminolevulinate. The goal isn't to treat a specific illness right now, but rather to understand how the cream behaves.

Specifically, they want to see how well each cream causes a particular natural chemical, called protoporphyrin IX, to form in the skin. This chemical is quite important because it's involved in some treatments for certain skin conditions. By running this small study, researchers can learn the best ways to apply the creams and measure the effects for bigger studies later on.

Think of it like a practice run before a big race. The information they get will help them set up future, larger studies more effectively, ensuring they use the right methods and measurements to get accurate results. This helps move new and improved skin treatments forward in a careful and scientific way.

Key takeaways

This is an early-stage study to understand skin creams.
It involves healthy adults only, aged 18 and over.
The goal is to compare two creams and how a natural chemical forms in the skin.
Your participation helps improve future skin treatments.
Risks are generally minor, like temporary skin irritation.

Who may be eligible?

This study is looking for healthy adult volunteers, aged 18 or older. It is open to both men and women.

Since this is a very early-stage study just to understand how creams work, you don't need to have any specific health conditions to take part. In fact, they are specifically looking for people who are generally well.

More detailed checks would happen if you were interested in joining, but generally, if you're over 18 and considered healthy, you might be suitable.

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?
Are you comfortable with creams being applied to your skin?
Are you able to attend study visits if required?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have cream applied to a small area of your skin. This might involve visiting the clinic a few times. During these visits, researchers would apply the different creams and then measure the amount of the chemical protoporphyrin IX that forms in your skin. These measurements might involve special lights or skin samples, but the study description doesn't give a lot of detail beyond that. The study is focused on understanding how the creams work, so there wouldn't be any specific 'treatment' for a condition, as it's for healthy volunteers. The total duration of your involvement isn't specified, but phase 1 studies are usually relatively short-term.

Potential risks and benefits

While there isn't a direct health benefit for you from participating in this study, your involvement is crucial for helping researchers learn more about how these creams work. This knowledge can lead to better treatments for others in the future. Potential risks might include mild skin reactions like redness, itching, or irritation where the cream is applied. As with any study, you are free to withdraw 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
France

Common questions

What is protoporphyrin IX?

It's a natural chemical that forms in your skin when certain creams are applied. Scientists are interested in how much of it forms because it's important for some skin treatments.

Will this study treat a skin condition?

No, this study is for healthy volunteers and is designed to understand how the creams work, not to treat any specific skin condition.

What does 'investigator masked' mean?

It means that the people giving you the cream won't know which specific version you are receiving. This helps make the study results fair and unbiased.

How long will I need to be involved?

The study description doesn't specify the exact duration, but early-stage studies like this are usually relatively short-term, involving a few visits.

What does 'Phase I' mean?

Phase I means it's one of the first human studies of a new drug or treatment. It usually involves healthy volunteers and focuses on safety and how the treatment works in the body.