Plaque Psoriasis Study in Pediatric Subjects

Galderma

Status and phase: Completed; Phase 4

Conditions: Plaque Psoriasis

Treatments: Drug: placebo comparator; Drug: calcitriol ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02186665

RD.06.SPR.18132

Details and patient eligibility

About

The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.

Enrollment: 19 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female 2 to 12 years 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19 participants in 2 patient groups, including a placebo group

calcitriol ointment

Experimental group

Description:

calcitriol 3 mcg/g ointment

Treatment:

Drug: calcitriol ointment

placebo

Placebo Comparator group

Description:

placebo comparator

Treatment:

Drug: placebo comparator