Phase 4
N=18
PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01766440 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Cmax of Calcitriol Plasma Level — 120.7 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Calcitriol 3 mcg/g ointment (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Nov 2015
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 | — |
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.
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.