Europas førende søgning efter kliniske forsøg

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 is absorbed into the body, and whether it affects the HPA axis, which helps control hormone balance.

Table of contents

Overview of the studies

Two clinical trials are studying HALOBETASOL PROPIONATE in pediatric subjects with moderate to severe plaque psoriasis.[1][1] Both studies use topical treatment, which means the medicine is applied to the skin.[1][1]

The trials are designed to learn about safety, how much of the treatment gets into the body, and whether it may cause HPA axis suppression, which means a change in the body’s hormone control system.[1][1]

Study design and phases

Both studies are open-label, so the people in the study and the researchers know what treatment is being used.[1][1] They are also multicenter, meaning they are carried out at more than one study site.[1][1]

In the source data, each study is described as Phase 4 and also as Phase 2 in the European Union.[1][1] This means the studies are being reported with phase labels that depend on the region or study framework used in the record.[1][1]

Who can take part

The target population in both trials is pediatric subjects, which means children and adolescents.[1][1] The condition being studied is moderate to severe plaque psoriasis.[1][1]

Each study lists an enrollment of 45 participants, so the planned study size is small and focused.[1][1]

What the trials measure

The main outcomes are centered on three questions. First, the studies measure safety of the topical lotion when used once daily.[1][1] Second, they measure systemic exposure, which means how much of the medicine is found in the blood after skin application.[1][1]

Third, the trials assess the potential for HPA axis suppression after once-daily use.[1][1] In simple terms, researchers want to know whether the treatment changes the body’s normal hormone signaling.[1][1]

The brief summaries also show different measurement periods. One study looks at safety over 8 weeks, systemic exposure over 4 weeks, and HPA axis suppression over 8 weeks.[1] The other study uses the same timing pattern for these outcomes.[1]

Details of the two trials

The first trial, 2024-520058-39-00, is authorised and studies topically applied IDP-122 lotion in pediatric subjects with moderate to severe plaque psoriasis.[1] The intervention is listed as Bryhali, and the study includes 45 participants.[1]

The second trial, 2024-520057-20-00, is completed and studies topically applied IDP-118 lotion in the same patient group.[1] The intervention is listed as Duobrii, and this study also includes 45 participants.[1]

Both studies are interventional, which means the researchers are giving a treatment and then measuring the results.[1][1]

What these studies may mean for patients

For families, these trials are mainly about learning whether topical treatment with HALOBETASOL PROPIONATE can be used safely in younger patients with more serious plaque psoriasis.[1][1] The focus is not only on skin improvement, but also on whether the treatment stays mostly on the skin or enters the body in a way that matters.[1][1]

Because the studies check hormone-related effects, they aim to give a clearer picture of how the treatment behaves in children and adolescents over several weeks of use.[1][1]

Trial ID Phase Condition studied Status Enrollment
2024-520058-39-00 Phase 2 Plaque Psoriasis Authorised 45
2024-520057-20-00 Phase 2 Plaque Psoriasis Completed 45

FAQ

  • Who is being studied in these trials? The trials focus on pediatric subjects, meaning children and adolescents, with moderate to severe plaque psoriasis.
  • What are the trials trying to find out? They are checking safety, how much HALOBETASOL PROPIONATE enters the bloodstream, and whether it may suppress the HPA axis. This helps researchers understand both local and body-wide effects.
  • What phase are these trials in? Both studies are Phase 2 in the European Union and Phase 4 in the overall study description.
  • What condition is being studied? Both trials are studying plaque psoriasis, a skin condition that causes raised, scaly patches.
  • How are the studies designed? They are open-label and multicenter studies. Open-label means everyone knows what treatment is given, and multicenter means the research is done at more than one site.

Igangværende kliniske forsøg for HALOBETASOL PROPIONATE

  • Test af IDP-122 lotion med halobetasol til behandling af moderat til svær plaque psoriasis hos børn og unge

    Rekrutterer

    1 1
    Undersøgte lægemidler:
    Polen

  • Undersøgelse af en ny lotion med halobetasol og tazaroten til behandling af moderat til svær plaque psoriasis hos børn og unge

    Rekrutterer ikke

    1 1 1
    Undersøgte lægemidler:
    Polen

Ordliste

  • Plaque psoriasis: A long-term skin condition that causes thick, red, scaly patches on the skin.
  • Moderate to severe: This means the condition is not mild and may affect a larger area of the skin or cause more serious symptoms.
  • Pediatric subjects: Children and adolescents who take part in a study.
  • Open-label: A study design where the participants and researchers know which treatment is being used.
  • Multicenter: A study carried out at more than one hospital or clinic.
  • Phase 2: An early stage of clinical research that helps researchers learn more about safety and how well a treatment works.
  • Phase 4: A later stage of research done after a treatment is already being studied in real-world use.
  • Systemic exposure: How much of a treatment gets into the bloodstream and spreads through the body.
  • Pharmacokinetics: How the body absorbs, moves, and removes a treatment.
  • HPA axis: A hormone control system involving the brain and adrenal glands that helps regulate stress and other body functions.

Referencer