PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Completed · Phase 4
Conditions studied: Plaque Psoriasis
In brief
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.
Key facts
- Study ID
- NCT01766440
- Run by
- Galderma R&D
- People needed
- 18
- Starts
- 2013-03-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2021-02-18
Who can join
Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Rady Children's Hospital - Pediatric and Adolescent Dermatology — San Diego, California, United States
- Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, 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
- Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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