Conditions: Chronic Plaque Psoriasis
Keywords: Calcitriol Psoriasis PK Adolescents
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief summary:
This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.

Detailed description:

Arms:
arm 1: Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.

Interventions: intervention 1: Calcitriol 3mcg/g
Intervention descriptions: intervention 1: Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.

Protocol document: