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RecruitingPHASE3INTERVENTIONAL

A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

This research is investigating a new cream designed to help children aged 3 months to under 2 years who have eczema (atopic dermatitis). The study is called a 'Phase 3' trial, which means it’s one of the final steps before a new treatment might become widely available. Doctors want to understand if the tapinarof cream is both safe to use and effective at reducing eczema symptoms. Some children will use the tapinarof cream, while others will use a cream that looks the same but contains no active medicine (a 'vehicle cream'). This comparison helps researchers determine if any improvements are truly due to the new medication. The goal is to find better ways to manage eczema for very young children.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Organon and Co
Enrolment target
180
Start
29 Dec 2025
Estimated completion
01 Jan 2028

What is this study about?

This study is looking at a new cream called tapinarof, specifically for babies and toddlers with eczema, also known as atopic dermatitis. Eczema can make a child's skin itchy, red, and dry, which can be very uncomfortable for them and worrying for their parents. The main aim of this research is to see how safe the tapinarof cream is and how well it works to improve eczema symptoms in children aged 3 months to just under 2 years old.

To do this, some children in the study will be given the tapinarof cream, while others will receive a plain cream that doesn't contain any active medicine. This plain cream is called a 'vehicle cream' and is used as a comparison. By comparing the two groups, researchers can tell if any changes in the children's eczema are truly due to the tapinarof cream rather than other factors.

This is a ‘Phase 3’ study, which is an important stage in developing new medicines. It means researchers have already done earlier tests and now need to confirm the cream’s safety and effectiveness in a larger group of people. The results from this study will help decide if tapinarof cream could become a new treatment option for very young children with eczema in the future.

Key takeaways

  • This study tests a new cream for eczema in babies and toddlers (3 months to under 2 years).
  • It aims to find out if the cream is safe and effective compared to a plain cream.
  • Children will either receive the new tapinarof cream or a look-alike cream without medicine.
  • Participation involves regular clinic visits and applying cream at home.
  • Your child's participation helps researchers find better treatments for eczema in young children.

Who may be eligible?

To join this study, your child needs to be between 3 months and under 2 years old and have a clear diagnosis of eczema. Their eczema should cover more than 5% of their body, and a doctor will need to confirm its severity.

You, as their parent or legal guardian, must be willing to provide permission for your child to take part. You also need to be able to follow all the instructions given by the study team throughout the research period.

There are also some reasons why a child might not be able to join the study. These include having certain other health conditions, like a history of seizures, serious heart problems, or other significant ongoing illnesses. Children who have a weak immune system, current serious infections, or are taking medications that might interfere with the study cream would also not be eligible. If a mother is breastfeeding a child in the study, she also can't be taking certain medications.

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. Is your child between 3 months and under 2 years old?
  2. Has your child been diagnosed with eczema by a doctor?
  3. Does your child's eczema cover more than 5% of their body?
  4. Are you able and willing to follow all study instructions?
  5. Does your child have any serious ongoing health conditions or take other specific medicines?
Answer every question to see your result.

What does participation involve?

If your child takes part in this study, you would bring them to several study visits at a clinic. At these visits, doctors and nurses would check your child's eczema, assess their general health, and record any changes. You would be given either the tapinarof cream or the vehicle cream to apply to your child's skin at home, following specific instructions. The study team would explain exactly how and when to apply the cream. There will be regular check-ups to monitor your child’s progress and safety. The study will involve a set duration of treatment and follow-up, which the study team will explain in detail during the consent process.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if the new cream helps your child's eczema. It also helps advance medical knowledge for other children in the future. However, there's always a possibility that the cream might not work for your child, or it could cause side effects like skin irritation. There's also a chance your child might receive the plain, inactive cream. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their regular medical care.

Locations (47)

  • AllerVie Clinical Research
    Verified postcode
    Birmingham, United States· Recruiting
  • Dermatology Trial Associates
    Verified postcode
    Bryant, United States· Recruiting
  • Dermatology Research Associates
    Verified postcode
    Los Angeles, United States· Recruiting
  • Integrative Skin Science and Research
    Verified postcode
    Sacramento, United States· Recruiting
  • Allergy and Asthma Medical Group and Research Center
    Verified postcode
    San Diego, United States· Recruiting
  • Clinical Trials Research Institute
    Verified postcode
    Thousand Oaks, United States· Recruiting
  • Clarity Dermatology
    Verified postcode
    Castle Rock, United States· Recruiting
  • Skin Care Research, LLC.
    Verified postcode
    Boca Raton, United States· Recruiting
  • APEX Clinical Trials
    Verified postcode
    Jacksonville, United States· Recruiting
  • TruDerm Research
    Verified postcode
    Wellington, United States· Recruiting
  • Cleaver Medical Group Dermatology, Inc
    Verified postcode
    Cumming, United States· Recruiting
  • Ada West Research
    Verified postcode
    Meridian, United States· Recruiting

Common questions

What is eczema (atopic dermatitis)?

Eczema is a common skin condition that makes skin dry, itchy, red, and sometimes cracked. It's not infectious and often starts in babies and young children.

What is a 'Phase 3' study?

A Phase 3 study is one of the final stages of research for a new medicine. It means the medicine has already been tested for safety and effectiveness in smaller groups, and now it's being tested in a larger group to get more information before it can be approved for wider use.

Will my child definitely get the new cream?

No, your child might receive either the new tapinarof cream or a plain cream without any active medicine (called a 'vehicle cream'). This is decided by chance, like flipping a coin, so researchers can fairly compare how well each works.

What if my child gets side effects?

The study team will closely monitor your child for any side effects. You should report any concerns immediately, and they will provide guidance and care. Your child's safety is a top priority.

How long will the study last for my child?

The study team will tell you the exact duration of your child's participation during the consent process. It typically involves a treatment period followed by a monitoring period.

How to find out more

Clinical Lead Late-Stage Clinical Development

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Investigate Safety and Efficacy of Tapinarof Crea…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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