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

• Status: Completed
• Trial end date: 2009-09-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Calcitriol

Criteria

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