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

Galderma

Status and phase: Completed; Phase 4

Conditions: Psoriasis Vulgaris

Treatments: Drug: Calcitriol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02125279

RD.06.SPR.18131

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Calcitriol ointment

Experimental group

Treatment:

Drug: Calcitriol