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

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis.

Official Title
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A Multicenter Open Label Uncontrolled Study of the Long Term Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 26 Weeks in Pediatric Subjects (2 to 16 Years and 11 mo of Age) With Mild to Moderate Plaque Psoriasis

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: Calcitriol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 2 to 16 years and 11 months of age Clinical diagnosis of stable mild to moderate plaque psoriasis Exclusion Criteria: Other forms of psoriasis Hypercalcemia Past history of kidney stones Vitamin D deficiency Other concomitant dermatological disease

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcitriol ointment<br> | Drug: Calcitriol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Screening in Serum Albumin Levels at Week 4 | Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported. | Screening, Week 4 | 
| Change From Screening in Serum Albumin Levels at Week 8 | Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported. | Screening, Week 8 | 
| Change From Screening in Serum Albumin Levels at Week 12 | Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported. | Screening, Week 12 | 
| Change From Screening in Serum Albumin Levels at Week 20 | Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported. | Screening, Week 20 | 
| Change From Screening in Serum Albumin Levels at Week 26 | Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported. | Screening, Week 26 | 
| Change From Screening in Serum Albumin Levels at Week 30 (Follow-up) | Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported. | Screening, Week 30 (Follow-up) | 
| Change From Screening in Urine Calcium/Creatinine Ratio at Week 12 | Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported. | Screening, Week 12 | 
| Change From Screening in Urine Calcium/Creatinine Ratio at Week 26 | Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported. | Screening, Week 26 | 
| Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up) | Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported. | Screening, Week 30 (Follow-up) | 
| Change From Screening in Serum Phosphate Levels at Week 4 | Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported. | Screening, Week 4 | 
| Change From Screening in Serum Phosphate Levels at Week 12 | Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported. | Screening, Week 12 | 
| Change From Screening in Serum Phosphate Levels at Week 20 | Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported. | Screening, Week 20 | 
| Change From Screening in Serum Phosphate Levels at Week 26 | Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported. | Screening, Week 26 | 
| Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up) | Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported. | Screening, Week 30 (Follow-up) | 
| Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4 | Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported. | Screening, Week 4 | 
| Change From Screening in Serum Parathyroid Hormone Levels at Week 8 | Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported. | Screening, Week 8 | 
| Change From Screening in Serum Parathyroid Hormone Levels at Week 12 | Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported. | Screening, Week 12 | 
| Change From Screening in Serum Parathyroid Hormone Levels at Week 20 | Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported. | Screening, Week 20 | 
| Change From Screening in Serum Parathyroid Hormone Levels at Week 26 | Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported. | Screening, Week 26 | 
| Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up) | Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported. | Screening, Week 30 (Follow-up) | 
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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. | Up to Week 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | 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). | Weeks 4, 8, 12, 20, 26 and 30 (Follow-up) | 
| Change From Baseline in Pruritus Score at Each Visit | 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. | Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up) | 
| Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit | 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. | Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up) |