PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the calcitriol absorption in pediatric subjects is comparable to that in adults and adolescents, with no significant impact on calcium/phosphorus metabolism.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Male or female pediatric subjects, 2 to 12 years of age inclusive at screening

• Clinical diagnosis of plaque type psoriasis involving 3% through 35% body surface area at screening and baseline (excluding face and scalp)

Exclusion Criteria:

• Subjects with guttate or pustular psoriasis, erythrodermic psoriasis or active infection

• Vitamin D deficiency at screening

• Subjects with hypercalcemia and out of range urinary calcium/creatinine ratio at screening

• Subjects with secondary hyperparathyroidism at screening