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



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:2 - 16
Updated:5/13/2018
Start Date:May 2014
End Date:May 2018

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Trial Summary
Trial Overview
Inclusion Criteria

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 Months of Age) With Mild to Moderate Plaque Psoriasis

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.


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
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