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

Phase 4

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Calcitriol 3 mcg/g ointment

• Registration Number: NCT01766440
• Lead Sponsor: Galderma R&D

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Study Start: 2013-03
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2017-02-15
• Results First Submitted QC: 2017-02-15
• Results First Posted: 2017-03-31
• Status Verified: 2017-04
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Calcitriol 3 mcg/g ointment	Calcitriol 3 mcg/g ointment	Topical application every 12 hours for 14 consecutive days

Primary Outcome Measures

Name	Time	Method
Tmax of Calcitriol Plasma Level	Day 14	Tmax of calcitriol plasma level at Day 14
AUC (0-6h) of Calcitriol Plasma Level	Day 14	AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)
AUC (0-9h) of Calcitriol Plasma Level	Day 14	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.)
AUC (0-12h) of Calcitriol Plasma Level	Day 14	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.)
Cmax of Calcitriol Plasma Level	Day 14	Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)
Cmin of Calcitriol Plasma Level	Day 14	Cmin of calcitriol plasma level at Day 14

Trial Locations

Locations (8)

Menter Dermatology Research Institute; 🇺🇸 Dallas, Texas, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

Rady Children's Hospital - Pediatric and Adolescent Dermatology; 🇺🇸 San Diego, California, United States

Dawes Fretzin Clinical Research Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

University of North Carolina Dermatology and Skin Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States

Clinical Trials of Texas, Inc.; 🇺🇸 San Antonio, Texas, United States