Active not recruitingPHASE3INTERVENTIONAL

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Doctors are studying a cream called tapinarof (1%) for children and teenagers aged 2 to 17 who have plaque psoriasis. This is a common skin condition that causes red, scaly patches. The study wants to find out how well this cream works and if it's safe to use. Participants will use the cream once a day for 12 weeks. After that, they might have the choice to continue using it for another 40 weeks to see its longer-term effects. This research aims to offer a new treatment option for young people living with plaque psoriasis.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Organon and Co

Enrolment target

Start

02 Dec 2021

Estimated completion

01 Oct 2026

Plaque Psoriasis

What is this study about?

If you or your child has plaque psoriasis, you know it can be a challenging condition, causing red, scaly patches on the skin. Medical professionals are always looking for better ways to help manage this, especially for children and teenagers. This current study is looking into a new cream called tapinarof, specifically for young people aged 2 to 17 with plaque psoriasis.

The main goal of this research is to see how effective and safe tapinarof cream is. It's what's called a 'Phase 3' study, which means it's one of the final steps before a new medicine might become widely available. The information gathered from this study will help doctors understand if this cream could be a good treatment option for young patients.

By taking part, you would be helping medical science learn more about plaque psoriasis treatments for young people. This could make a real difference to future patients.

Key takeaways

This study is for children and teenagers (2-17 years old) with plaque psoriasis.
It's testing a new cream called tapinarof (1%) applied once daily.
The initial treatment period is 12 weeks, with an optional 40-week extension.
Participation involves regular clinic visits for check-ups.
This research aims to find new, safe treatments for young people with psoriasis.
You can stop participating at any time.

Who may be eligible?

This study is for children and teenagers who: are between 2 and 17 years old, have been diagnosed with chronic plaque psoriasis, and have had their skin condition stable for at least 3 months. Their psoriasis needs to cover at least 3% of their body and be noticeable enough for doctors to assess.

There are some reasons why someone might not be able to join. This includes having other types of psoriasis (not plaque psoriasis), an infection in their psoriasis patches, or if they have certain health conditions like liver problems, a serious illness, or recent major surgery. Also, if a female participant could become pregnant, they must use effective contraception.

It's important that the child or their parent/guardian understands the study and can agree to take part.

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.

Is the person aged between 2 and 17 years?
Do they have a diagnosis of chronic plaque psoriasis?
Has their psoriasis been stable for the last 3 months?
Does their psoriasis cover at least 3% of their body (e.g., roughly the size of 3 adults' hands)?
Is there no current active infection in their psoriasis patches?
Are female participants (old enough to potentially become pregnant) using reliable birth control?

Answer every question to see your result.

What does participation involve?

If you join this study, you or your child will use the tapinarof cream (1%) once a day. Initially, you'll use the cream for 12 weeks. After these 12 weeks, you'll have the choice to continue using the cream for another 40 weeks, making the total treatment period up to 52 weeks. Throughout this time, you will have regular visits to the clinic so doctors can check on your skin, general health, and how well the treatment is working.

If you decide not to continue after the first 12 weeks, there will be one final check-up visit about a week later. During your visits, doctors will likely examine your skin, ask questions about your health, and might take blood samples to monitor your health. The total duration of your participation could be around 13 weeks if you stop after the first phase, or up to about 53 weeks if you continue for the longer period.

Potential risks and benefits

Taking part in a study like this might have potential benefits, like access to a new treatment for plaque psoriasis before it's widely available, and close medical monitoring. However, there are also potential risks; the cream might not work for everyone, or it could cause side effects, though the study is designed to carefully monitor for these. You will be given full details of known side effects. Remember, joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (19)

Northwest Arkansas Clinical Trials Center, PLLC
Verified postcode
Rogers, United States
First OC Dermatology
Verified postcode
Fountain Valley, United States
Mission Dermatology Center
Verified postcode
Rancho Santa Margarita, United States
RM Medical Research
Verified postcode
Miami Lakes, United States
San Marcus Research Clinic, Inc.
Verified postcode
Miami Lakes, United States
Olympian Clinical Research
Verified postcode
Tampa, United States
Northwestern University Feinberg School of Medicine
Verified postcode
Chicago, United States
Dawes Fretzin Clinical Research Group
Verified postcode
Indianapolis, United States
Options Research Group
Verified postcode
West Lafayette, United States
Wright State Physicians Pharmacology Translational Unit
Verified postcode
Fairborn, United States
Oregon Dermatology & Research Center
Verified postcode
Portland, United States
Dermatology Specialists of Spokane
Verified postcode
Spokane, United States

Common questions

What is plaque psoriasis?

It's a common, long-lasting skin condition that causes red, flaky, crusty patches covered with silvery scales.

Who can take part in this study?

Children and teenagers aged 2 to 17 with chronic plaque psoriasis that covers at least 3% of their body.

What is tapinarof cream?

It's an investigational cream (medicine being studied) that's being tested to see if it helps improve plaque psoriasis.

How long does the study last?

The main part is 12 weeks, but you might be able to continue for another 40 weeks, making it up to a year in total.

Can I stop participating if I want to?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your regular medical care.