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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01766440
First received: January 9, 2013
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Plaque Psoriasis Drug: Calcitriol 3 mcg/g ointment Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Cmax of Calcitriol Plasma Level [ Time Frame: 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 [ Time Frame: Day 14 ]
    Cmin of calcitriol plasma level at Day 14

  • Tmax of Calcitriol Plasma Level [ Time Frame: Day 14 ]
    Tmax of calcitriol plasma level at Day 14

  • AUC (0-6h) of Calcitriol Plasma Level [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.)


Enrollment: 18
Study Start Date: March 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcitriol 3 mcg/g ointment
Topical application every 12 hours for 14 consecutive days
Drug: Calcitriol 3 mcg/g ointment
Topical ointment; twice daily application

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766440

Locations
United States, California
Rady Children's Hospital - Pediatric and Adolescent Dermatology
San Diego, California, United States, 92123
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
University of North Carolina Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, United States, 27516
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Texas
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Galderma
Investigators
Study Director: Michael Graeber, M.D. Galderma R&D, LLC
  More Information

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01766440     History of Changes
Other Study ID Numbers: RD.06. SPR.18104
Study First Received: January 9, 2013
Results First Received: February 15, 2017
Last Updated: April 19, 2017

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 24, 2017