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AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Phase I clinical trial evaluating the safety, tolerability, and absorption of a topical product containing latanoprost acid in healthy participants.

This study is an early look at a new cream designed to help with a common type of hair loss called androgenetic alopecia. It's a 'Phase 1' study, which means the main goal is to check if the cream is safe to use and how well it's absorbed by the body. The researchers will be giving the cream to healthy adults and carefully watching for any side effects. This step is really important because it helps scientists understand if a new medicine is safe enough to test further in people who actually have the condition. It's the essential first step before a potential new treatment can be developed.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Bioresearch Pharma S.A.
Enrolment target
24
Start
29 Apr 2026

What is this study about?

This study is about a new skin cream that could potentially help with a common type of hair loss, often called male or female pattern baldness. Scientists are always working to find better ways to treat conditions, and this cream is one of those new ideas.

This particular study is a very early stage of testing, known as a 'Phase 1' trial. Think of it like a first test drive for a new car. The main goal here isn't to see if the cream regrows hair yet. Instead, the researchers want to answer two main questions: Is it safe to use on the skin? And how well does the body take in the medicine from the cream? They'll be giving the cream to healthy volunteers and watching very closely for any unwanted effects.

Gathering this safety information is a crucial step. If the cream proves to be safe and absorbed as expected, it means that researchers can then consider moving on to bigger studies. In those future studies, they would begin to test if the cream actually helps people who have hair loss. Every new medicine starts with these careful safety checks.

Key takeaways

  • This study is testing a new cream for hair loss.
  • It's an early-stage study focused on safety, not hair regrowth.
  • Healthy adults aged 18 and over, both men and women, can take part.
  • Participants will apply the cream and have regular health checks.
  • The goal is to see if the cream is safe and how it's absorbed by the body.
  • You can always change your mind and leave the study at any time.

Who may be eligible?

To join this study, you need to be a healthy adult, 18 years old or older. The study is open to both men and women.

Because this is a safety study, they are looking for people who are generally well and don't have other serious health problems that might affect how their body reacts to the cream.

Specific details about other health conditions, medications you take, or allergies might also be important, but this basic information tells you who they are generally looking for.

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.

  1. Are you 18 years old or older?
  2. Are you generally healthy?
  3. Are you a man or a woman?
  4. Are you able to attend study appointments as required?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given the new cream to apply. The study team would explain exactly how and when to use it. You would have several visits to the study clinic where nurses and doctors would check your health, ask about any side effects, and take samples (like blood or urine) to see how your body is handling the cream. These checks help them understand if the cream is safe and how it's being absorbed. The total length of your participation, including all visits and follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in a study like this means you would be among the first to try a new treatment, which could potentially contribute to finding new ways to treat hair loss for others in the future. However, there are also risks; you might experience side effects from the cream, some of which could be unexpected or unpleasant. The medical team will monitor you closely for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Common questions

What is 'Phase 1' study?

It's the very first stage of testing a new medicine in people. The main goals are to check if it's safe to use and how the body handles it.

Will this cream regrow my hair?

This study isn't designed to find out if it regrows hair. Its main purpose is to check for safety and how the body absorbs the cream in healthy people.

Do I need to have hair loss to join?

No, this study is actually looking for generally healthy adults, not people who necessarily have hair loss, to check the cream's safety.

How long would I be in the study?

The exact duration would be explained by the study team, including how often you'd need to visit and for how long.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point, and it won't affect your future medical care.

How to find out more

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

Discussion

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