A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis

PK and PD of Calcitriol Following Twice Daily Application of Calcitriol 3 µg/g Ointment Under Conditions of Maximal Use in Adolescents With Plaque Psoriasis

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.

Inclusion Criteria:

• Diagnosis of chronic plaque psoriasis
• 10 - 35% BSA of involved skin
• Age 12 - 17

Exclusion Criteria:

• Other type of psoriasis (other than plaque)
• Significant abnormal lab findings
• Vit D insufficiency