PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Calcitriol 3 mcg/g ointment

Topical application every 12 hours for 14 consecutive days

Group Type EXPERIMENTAL

Calcitriol 3 mcg/g ointment

Intervention Type DRUG

Topical ointment; twice daily application

Interventions

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Calcitriol 3 mcg/g ointment

Topical ointment; twice daily application

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No