Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 4 (Phase 2 in European Union), Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion in Pediatric Subjects with Moderate to Severe Plaque Psoriasis

This research study is investigating a new lotion called Duobrii, which is used to treat moderate to severe plaque psoriasis in children and teenagers. The main goals are to understand how much of the medicine is absorbed into the body when applied to the skin once a day, and to ensure it's safe. Researchers are also checking if the lotion affects a specific hormone system in the body called the HPA axis, which is involved in stress response. This study is designed to help doctors understand the new treatment better and ensure it can be safely used by young people with this skin condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Bausch Health Americas Inc.

Enrolment target

Start

28 Jan 2025

Plaque Psoriasis

What is this study about?

Imagine you have plaque psoriasis, a condition where your skin gets thick, red, and scaly patches. Doctors are always looking for better and safer ways to help people, especially children and teenagers, manage this condition. This study is all about a new lotion called Duobrii, which doctors think might help tackle plaque psoriasis.

The main thing doctors want to find out is how well this lotion works and how safe it is for young people. They'll be looking closely at a few important things. Firstly, they want to see how much of the medicine soaking into the skin actually gets into the bloodstream. This is important because too much or too little could affect how well it works or if it causes any side effects.

Secondly, they're checking if using the lotion once a day is safe overall. They'll be watching out for any unexpected problems. Lastly, they're keen to see if the lotion affects a special system in your body called the Hypothalamic-Pituitary-Adrenal (HPA) axis. This system helps control things like stress and how your body uses energy, so it's important to make sure the lotion doesn't upset its balance. This study is a step towards making sure Duobrii is a good and safe option for young people with plaque psoriasis.

Key takeaways

This study is testing a new lotion called Duobrii for plaque psoriasis.
It aims to see how much medicine the body absorbs and if it's safe.
Doctors will check its effects on a key hormone system in the body.
Participants must be aged 18 or older with moderate to severe plaque psoriasis.
The study helps improve understanding of new treatments.

Who may be eligible?

To join this study, participants need to be at least 18 years old. While the initial request mentioned pediatric subjects, the eligibility criteria provided only states '18 Years to any' for age. This means the study is looking for adults aged 18 and older.

However, it's worth noting the trial title mentions 'pediatric subjects,' which typically refers to children and adolescents. If you are under 18 and interested in a study for younger people, make sure to ask your doctor for options that truly match that age group.

Both males and females can take part in this study. The most important thing is that you have moderate to severe plaque psoriasis. Your doctor will be able to tell you if your psoriasis fits these criteria.

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?
Have you been diagnosed with plaque psoriasis?
Is your plaque psoriasis considered 'moderate to severe' by a doctor?
Are you able to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve applying the Duobrii lotion to your skin once a day. You would have regular visits to the clinic so doctors can check your skin, see how the treatment is working, and make sure you're feeling well. During these visits, there would be assessments like blood tests to see how much of the medicine is in your body and to check your hormone levels. This helps doctors understand the medication's effect. You would also be asked questions about your general health and any changes you notice. The study would last for a specific period of time, which your doctor or the study team would explain in detail.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as gaining access to a new treatment for your plaque psoriasis before it's widely available. It also contributes to medical knowledge, which could help future patients. However, there are also potential risks, including side effects from the medication or the study procedures. The lotion might irritate your skin, or there could be other effects on your body. You will be closely monitored for any problems, and you have the right to leave 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.

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Unverified
Poland

Common questions

What is plaque psoriasis?

Plaque psoriasis is a common skin condition where skin cells grow too quickly, leading to thick, red, scaly patches on the skin.

What is Duobrii?

Duobrii is a new lotion being tested in this study to treat plaque psoriasis.

Will I have to pay to be in the study?

No, you should not have to pay to participate in a clinical trial. All study-related medication and tests are typically covered.

What does 'moderate to severe' plaque psoriasis mean?

This means your psoriasis covers a noticeable amount of your body, or significantly affects your daily life, and is more than just a few small patches.

What if I experience side effects?

If you experience any side effects, you should tell the study doctors or nurses immediately. They will monitor you closely and provide care.