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

Galderma

Status and phase: Completed; Phase 4

Conditions: Plaque Psoriasis

Treatments: Drug: Calcitriol 3 mcg/g ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01766440

RD.06. SPR.18104

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Calcitriol 3 mcg/g ointment

Experimental group

Description:

Topical application every 12 hours for 14 consecutive days

Treatment:

Drug: Calcitriol 3 mcg/g ointment