A multi-center, open-label study that will evaluate the safety/tolerability and pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50 evaluable adolescents 12 to \< 17 years of age.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
pefcalcitol ointment, 0.005%
Change in incidence and severity of application site adverse events
Time frame: screening, weeks 0,2,4 and 8
Change in incidence and severity of all AEs and their relationship to study drug
Time frame: screening, weeks 0,2,4 and 8
Changes from baseline (pre-dose, Day 1) in safety laboratory parameters
Time frame: week 8
Changes from baseline (pre-dose, Day 1) in calcium homeostasis parameters (total serum calcium and albumin-corrected calcium levels, plasma parathyroid hormone (PTH), and serum alkaline phosphatase)
Time frame: week 8
Determination of plasma concentrations of Pefcalcitol and its metabolites
Time frame: Day 1 and Day 15
Proportion of subjects with an IGA score of absence (0) or very mild (1) with a minimum of a 2-grade improvement from baseline
Time frame: week 8
Proportion of subjects who achieved an mPASI 75 from baseline (Week 0) to Week 8, or who achieved an mPASI 50 and a 5-point improvement in the CDLQI from baseline
Time frame: week 8
Proportion of subjects who achieved success in each of the three individual components of the mPASI (scaling, thickness and erythema) from baseline
Time frame: week 8
Proportion of subjects who achieved a 5-point improvement in the CDLQI from baseline
Time frame: week 8
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