PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Information source: Galderma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Plaque Psoriasis
Intervention: Calcitriol 3 mcg/g ointment (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Galderma Official(s) and/or principal investigator(s): Michael Graeber, M.D., Study Director, Affiliation: Galderma R&D, LLC
Overall contact: Angela Fernando, Phone: 609-860-8254, Email: angela.fernando@galderma.com
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.
Clinical Details
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
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: C max of calcitriol plasma levelC min of calcitriol plasma level T max of calcitriol plasma level AUC of calcitriol plasma level
Secondary outcome: Calcium homeostasis parameters
Eligibility
Minimum age: 2 Years.
Maximum age: 12 Years.
Gender(s): Both.
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
Locations and Contacts
Angela Fernando, Phone: 609-860-8254, Email: angela.fernando@galderma.com
Rady Children's Hospital - Pediatric and Adolescent Dermatology, San Diego, California 92123, United States; Recruiting Nicola Borok, RN,CCRC, Phone: 858-576-1700, Ext: 4295, Email: nborok@rchsd.org Lawrence Eichenfield, MD, Principal Investigator
Ameriderm Research, Ormond Beach, Florida 32174, United States; Withdrawn
Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana 46256, United States; Recruiting Ashley Wallace, Phone: 317-621-7731, Ext: 119, Email: awallace@ecommunity.com Scott A Fretzin, MD, Principal Investigator
University of Michigan Medical Center, Ann Arbor, Michigan 48109, United States; Recruiting Kathryn Keeley, CCRP, Phone: 734-763-9187, Email: ktkeeley@umich.edu Yolanda Helfrich, MD, Principal Investigator
University of North Carolina Dermatology and Skin Cancer Center, Chapel Hill, North Carolina 27516, United States; Recruiting Erika Hanami, Phone: 919-843-5126 Aida Lugo-Somolinos, MD, Principal Investigator
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States; Recruiting Laurie Vanderah, RN, BSN, Phone: 513-803-0003 Kara Shah, MD, Principal Investigator
TriCities Skin and Cancer, Johnson City, Tennessee 37601, United States; Withdrawn
Menter Dermatology Research Institute, Dallas, Texas 75246, United States; Recruiting Mia Robinson, Phone: 972-354-7992 Alan Menter, MD, Principal Investigator
Clinical Trials of Texas, Inc., San Antonio, Texas 78229, United States; Recruiting Amy Griffith, Phone: 210-949-0122 Elizabeth Tichy, MD, Principal Investigator
Seattle Children's Hospital, Seattle, Washington 98105, United States; Recruiting Janna Stults, MPH, Phone: 206-884-3691, Email: janna.stults@seattlechildrens.org Heather Brandling-Bennett, MD, Principal Investigator
Additional Information
Starting date: March 2013
Last updated: August 6, 2015
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