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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 level

C 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

Page last updated: August 23, 2015

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