Phase 4
Completed N=18
PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Source: ClinicalTrials.gov NCT01766440 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Cmax of Calcitriol Plasma Level — 120.7 pg/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Calcitriol Plasma Level |
120.7 | — |
| PRIMARY Cmin of Calcitriol Plasma Level |
92.6 | — |
| PRIMARY Tmax of Calcitriol Plasma Level |
1.46 | — |
| PRIMARY AUC (0-6h) of Calcitriol Plasma Level |
650.3 | — |
| PRIMARY AUC (0-9h) of Calcitriol Plasma Level |
952.6 | — |
| PRIMARY AUC (0-12h) of Calcitriol Plasma Level |
1268.9 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01766440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.