In short
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.
Key points
- Clinical trials of HALOBETASOL PROPIONATE are being done in pediatric patients with moderate to severe plaque psoriasis. The studies are open-label and multicenter, which means the treatment is known to everyone and is tested at more than one site. They focus on safety, how much medicine enters the body, and whether the HPA axis is suppressed. Both studies are Phase 2 in the European Union and Phase 4 in another classification. One trial is authorised and one is completed, and each includes 45 participants.
Trial overview
Two interventional studies are listed for HALOBETASOL PROPIONATE in children with plaque psoriasis, a skin condition that causes raised, scaly patches. Both studies are described as Phase 4 in one setting and Phase 2 in the European Union. The main goal is to learn more about safety and how the treatment behaves in the body when used on the skin.
Who the trials are for
These trials focus on pediatric subjects, meaning children and adolescents. The condition being studied is moderate to severe plaque psoriasis, so the studies are not for mild disease. This helps researchers understand how HALOBETASOL PROPIONATE performs in a younger group with more active skin disease.
What the trials measure
The first main outcome is safety, which means watching for any problems while the treatment is used once daily. The studies also measure systemic exposure, which is how much of the treatment gets into the bloodstream after skin use. Another key endpoint is HPA axis suppression potential, meaning whether the body’s hormone control system is affected.
In one study, the outcomes include safety for 8 weeks, systemic exposure for 4 weeks, and HPA axis suppression potential for 8 weeks. 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.
How the studies are designed
Both studies are open-label, which means the treatment is not hidden from the research team or the participants. They are also multicenter, so they are carried out at more than one site. Both are interventional trials, meaning the researchers give a treatment and then observe the results.
Trial status and enrollment
One study is listed as Authorised, and the other is listed as Completed. Each trial planned to include 45 participants. This gives a small but focused group for studying treatment safety and body exposure in pediatric psoriasis.
Study products named in the records
The records name Bryhali in one trial and Duobrii in the other trial. The first trial identifies Bryhali as IDP-122 Lotion with HALOBETASOL PROPIONATE 0.01%. The second trial identifies Duobrii as IDP-118 Lotion with HALOBETASOL PROPIONATE 0.01% and tazarotene 0.045%. These names are included because they are part of the trial records, and they help distinguish the study products being tested.