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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:2 - 12
Updated:4/21/2016
Start Date:March 2013
End Date:December 2015

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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

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.


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
We found this trial at
8
sites
1224
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from 91732
Dallas, TX
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
1880
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Cincinnati, OH
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
1182
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San Antonio, TX
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Ann Arbor, Michigan 48109
1953
mi
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Ann Arbor, MI
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2194
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Chapel Hill, NC
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Indianapolis, Indiana 46256
1801
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Indianapolis, IN
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100
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San Diego, CA
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
964
mi
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Seattle, WA
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