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HALOBETASOL PROPIONATE

Clinical trials are studying HALOBETASOL PROPIONATE in children and adolescents with moderate to severe plaque psoriasis. These studies look at safety, how much of the medicine enters the body, and whether it affects the HPA axis, which helps control stress hormones. The trials are open-label and multicenter.

Table of Contents

Trial overview

Two interventional studies are listed for HALOBETASOL PROPIONATE in children with plaque psoriasis, a skin condition that causes raised, scaly patches.[1][2] Both studies are described as Phase 4 in one setting and Phase 2 in the European Union.[1][2] The main goal is to learn more about safety and how the treatment behaves in the body when used on the skin.[1][2]

Who the trials are for

These trials focus on pediatric subjects, meaning children and adolescents.[1][2] The condition being studied is moderate to severe plaque psoriasis, so the studies are not for mild disease.[1][2] This helps researchers understand how HALOBETASOL PROPIONATE performs in a younger group with more active skin disease.[1][2]

What the trials measure

The first main outcome is safety, which means watching for any problems while the treatment is used once daily.[1][2] The studies also measure systemic exposure, which is how much of the treatment gets into the bloodstream after skin use.[1][2] Another key endpoint is HPA axis suppression potential, meaning whether the body’s hormone control system is affected.[1][2]

In one study, the outcomes include safety for 8 weeks, systemic exposure for 4 weeks, and HPA axis suppression potential for 8 weeks.[1] In the other study, the same types of outcomes are measured, but the product includes both HALOBETASOL PROPIONATE and another ingredient listed in the trial record.[2]

How the studies are designed

Both studies are open-label, which means the treatment is not hidden from the research team or the participants.[1][2] They are also multicenter, so they are carried out at more than one site.[1][2] Both are interventional trials, meaning the researchers give a treatment and then observe the results.[1][2]

Trial status and enrollment

One study is listed as Authorised, and the other is listed as Completed.[1][2] Each trial planned to include 45 participants.[1][2] This gives a small but focused group for studying treatment safety and body exposure in pediatric psoriasis.[1][2]

Study products named in the records

The records name Bryhali in one trial and Duobrii in the other trial.[1][2] The first trial identifies Bryhali as IDP-122 Lotion with HALOBETASOL PROPIONATE 0.01%.[1] The second trial identifies Duobrii as IDP-118 Lotion with HALOBETASOL PROPIONATE 0.01% and tazarotene 0.045%.[2] These names are included because they are part of the trial records, and they help distinguish the study products being tested.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-520058-39-00 Phase 2 Moderate to severe plaque psoriasis Authorised 45
2024-520057-20-00 Phase 2 Moderate to severe plaque psoriasis Completed 45

FAQ

  • Who can join trials of HALOBETASOL PROPIONATE? The trials listed here are for pediatric subjects with moderate to severe plaque psoriasis. This means children or adolescents with a specific type of psoriasis affecting the skin.
  • What are these trials trying to find out? They are checking safety, systemic exposure, and HPA axis suppression potential. In simple terms, they want to know how well the treatment is tolerated, how much enters the body, and whether it affects hormone control.
  • What phase are the trials in? Both studies are Phase 2 in the European Union and Phase 4 in another classification. This means they are later-stage studies that focus on further testing in real-world-like settings.
  • What condition is being studied? Both trials study plaque psoriasis. The condition is described as moderate to severe, which means the skin disease is more than mild and needs careful treatment study.
  • Are the studies open-label? Yes. Open-label means that the researchers and participants know what treatment is being given. This design is often used to measure safety and body exposure more clearly.

Ongoing Clinical Trials on HALOBETASOL PROPIONATE

  • Study on the Effects of IDP-122 Lotion for Children with Moderate to Severe Plaque Psoriasis

    Recruiting

    2 1 1
    Investigated drugs:
    Poland

  • Study on the Effects of IDP-118 Lotion (Tazarotene and Halobetasol Propionate) for Children with Moderate to Severe Plaque Psoriasis

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Poland

Glossary

  • Plaque psoriasis: A long-term skin condition that causes raised, scaly patches on the skin.
  • Moderate to severe: A description of how serious a condition is. In these trials, it means the psoriasis is not mild.
  • Pediatric subjects: Children or adolescents who take part in a clinical trial.
  • Open-label: A study design where everyone knows which treatment is being used.
  • Multicenter: A study done at more than one hospital or clinic.
  • Interventional study: A trial in which researchers give a treatment and then measure the results.
  • Systemic exposure: How much of the treatment gets into the bloodstream and spreads through the body.
  • Pharmacokinetics: The study of what the body does with a treatment, including how it is absorbed and processed.
  • HPA axis: A hormone control system that helps the body respond to stress.
  • HPA axis suppression: A decrease in how well the hormone control system works.

References

  1. https://clinicaltrials.gov/study/2024-520058-39-00
  2. https://clinicaltrials.gov/study/2024-520057-20-00