Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported.

Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported.

Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported.

Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported.

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported.

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported.

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with an onset date on or after the first application of the study drug.

The IGA is a 0 to 4 point scale. Where, 0 = clear (no signs of psoriasis except for residual hypopigmentation/hyperpigmentation); 1 = almost clear (just perceptible erythema, no induration, and no scaling); 2 = mild (mild erythema, no induration, and mild or no scaling); 3 = moderate (moderate erythema, mild induration, and mild or no scaling); 4 = severe (severe erythema, moderate to severe induration, and scaling of any degree).

Pruritus was scored on a 0 to 4 point scale. Where, 0 = none (no-itching); 1 = mild (slight itching, not really bothersome); 2 = moderate (definite itching that is somewhat bothersome without loss of sleep); 3 = severe (intense itching that has caused pronounced discomfort, night rest interrupted); 4 = very severe (very severe itching that has caused pronounced discomfort during the night and daily activities). Positive change from baseline indicate worsening of indication.

Percent BSA was calculated by modified rules of nines (pediatric participants). Estimate were made from the following for a child up to the age of one year: head and neck total for front and back - 18%; thorax and abdomen-front -18%; thorax and abdomen-back - 18%; each upper limb total for front and back - 9%; each lower limb total for front and back - 14%. For over the age of one year, the relative percentage of BSA changes as follows: the head decreases by 1% per year and the lower limbs increase by 0.5% per year. By the age of ten years, the relative proportions assume the values for adult BSA as follows: perineum becomes 1%; each lower limb becomes a total of 18% front and back; head and neck become 9% total for front and back.