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-122 Lotion in Pediatric Subjects with Moderate to Severe Plaque Psoriasis
Plaque psoriasis causes raised, red, and scaly patches on the skin that can feel itchy or sore. Strong steroid lotions are often used to calm this inflammation, but doctors need to know how safe they are for younger patients. This study is testing a lotion named Bryhali (halobetasol propionate 0.01%) in children and young people with moderate to severe plaque psoriasis. Everyone taking part uses the study lotion once a day on their affected skin. Researchers want to see how safe the lotion is and how much medicine gets absorbed into the bloodstream. They will also test whether the lotion affects the body's natural hormone-producing system (the adrenal glands). The results will help doctors understand how to treat young people with psoriasis safely and effectively.
At a glance
What is this study about?
Plaque psoriasis is a long-term skin condition where skin cells build up too quickly, creating thick, red patches covered in silvery scales. In children and teenagers, these patches can be uncomfortable, itchy, and distressing. While many treatments exist for adults, medicines must be tested carefully in younger age groups to make sure they are safe for growing bodies.
Bryhali is a lotion containing a steroid medicine called halobetasol propionate. Steroid lotions help to reduce swelling, redness, and itching. Because children have thinner skin and smaller bodies than adults, their skin can sometimes absorb more medicine into their bloodstream. This study aims to measure exactly how much of the lotion enters the body and how it is processed.
Doctors are especially interested in the body's hormone control centre, known as the HPA axis (hypothalamic-pituitary-adrenal axis). This system controls cortisol, an important hormone that helps the body handle stress. Strong steroid lotions can sometimes tell the body to pause its own cortisol production. This study carefully checks the blood to see if that happens and whether hormone levels return to normal quickly.
By taking part, families help researchers find out whether Bryhali is a safe option for young people. It also helps doctors choose the right doses for children in the future, giving them better ways to manage severe flare-ups.
Key takeaways
- Tests the safety of Bryhali lotion in children and teenagers with plaque psoriasis.
- Every participant receives the active study lotion to use once daily.
- Carefully monitors how much medicine is absorbed into the bloodstream.
- Checks that the body's natural hormone production remains healthy.
- Participation is voluntary and you can stop at any time.
Who may be eligible?
This clinical trial is designed for children and teenagers who have been diagnosed with moderate to severe plaque psoriasis. A study doctor will examine the skin to confirm that enough of the body is affected to take part in the research.
Because this study looks closely at hormone levels, children might not be able to take part if they have used certain steroid creams, oral steroids, or light therapies very recently. The study team will need a complete list of all medications the child has used in the past few weeks.
Young people with other major medical conditions, known allergies to steroid lotions, or skin infections in the treatment areas may also be unable to join. A full health check is carried out before any child is accepted into the trial.
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.
- The patient is a child or teenager.
- Diagnosed with moderate to severe plaque psoriasis.
- Has active psoriasis patches suitable for topical treatment.
- Able to attend regular clinic visits and have routine blood tests.
- Willing to follow the daily lotion application instructions.
What does participation involve?
If you and your child decide to take part, the trial will involve several clinic visits over a set number of weeks. During the first visit, the study team will carry out health checks, look closely at the psoriasis patches, and take blood and urine samples to check baseline hormone levels.
Parents or young people will apply the lotion once a day at home to the patches of psoriasis, following clear instructions from the team. You may be asked to keep a simple daily diary to record when the lotion was put on.
During follow-up visits, doctors will check how the skin is responding and run specific blood tests to measure how much medicine has entered the bloodstream. They will also do tests to see how the adrenal glands are working. After finishing the lotion treatment, there will usually be a final check-up visit to ensure the child remains well.
Potential risks and benefits
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Common questions
Will my child receive a dummy treatment (placebo)?
No. This is an open-label study, which means every child who joins receives the active Bryhali lotion.
What is the HPA axis?
It is a network between the brain and the adrenal glands that makes cortisol, an essential hormone. The study checks that the lotion does not interfere with this system.
Are blood tests required?
Yes. Blood tests are needed to measure the amount of medicine absorbed and to check natural hormone levels safely.
How long does the study last?
The study usually lasts several weeks to allow enough time to treat the skin and monitor hormone recovery, but the study team will give you an exact schedule.
Does taking part cost anything?
No. The trial medication, clinic visits, and all tests are provided free of charge, and travel expenses are often covered.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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