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

Status:	Completed
Conditions:	Psoriasis
Therapuetic Areas:	Dermatology / Plastic Surgery
Healthy:	No
Age Range:	2 - 12
Updated:	4/21/2016
Start Date:	March 2013
End Date:	December 2015

Pharmacokinetics and Pharmacodynamics of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 14 Days Under Conditions of Maximal Use in Pediatric Subjects (2 to 12 Years of Age) With Plaque Psoriasis

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.

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

We found this trial at

sites

University of Michigan Medical Center

Ann Arbor, Michigan 48109

from

Ann Arbor, MI