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

Galderma R&D18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Plaque Psoriasis

Interventions

Calcitriol 3 mcg/g ointmentDRUG

Topical ointment; twice daily application

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (8)

Rady Children's Hospital - Pediatric and Adolescent Dermatology

San Diego, California, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Cmax of Calcitriol Plasma Level

Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)

Time frame: Day 14

Cmin of Calcitriol Plasma Level

Cmin of calcitriol plasma level at Day 14

Time frame: Day 14

Tmax of Calcitriol Plasma Level

Tmax of calcitriol plasma level at Day 14

Time frame: Day 14

AUC (0-6h) of Calcitriol Plasma Level

AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)

Time frame: Day 14

AUC (0-9h) of Calcitriol Plasma Level

AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of \<15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.)

Time frame: Day 14

AUC (0-12h) of Calcitriol Plasma Level

AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of \< 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.)

Time frame: Day 14

Data from ClinicalTrials.gov

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