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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766440
• Other study ID #: RD.06. SPR.18104
• Status: Completed
• Phase: Phase 4
• Start date: March 2013
• Est. completion date: November 2015

Study information

• Verified date: April 2017
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Calcitriol 3 mcg/g ointment
Topical ointment; twice daily application

Locations

Country	Name	City	State
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	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Rady Children's Hospital - Pediatric and Adolescent Dermatology	San Diego	California
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Calcitriol Plasma Level	Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)	Day 14
Primary	Cmin of Calcitriol Plasma Level	Cmin of calcitriol plasma level at Day 14	Day 14
Primary	Tmax of Calcitriol Plasma Level	Tmax of calcitriol plasma level at Day 14	Day 14
Primary	AUC (0-6h) of Calcitriol Plasma Level	AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)	Day 14
Primary	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.)	Day 14
Primary	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.)	Day 14