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Completed

NCT Number: NCT02186665

Plaque Psoriasis Study in Pediatric Subjects

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.

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Key information

Conditions

Plaque Psoriasis

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCL Saint Luc, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

calcitriol ointment

Drug

placebo comparator

Drug

Primary outcomes

  1. Success of Investigator's Global Assessment (IGA)

    Time frame: Baseline to Week 8

    The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF).

    The IGA was evaluated at each visit on the following 0 to 4 point scale:

    0 - Clear: No signs of psoriasis except for residual hypopigmentation / hyperpigmentation

    • - Almost Clear: Just perceptible erythema, no induration, and no scaling
    • - Mild: Mild erythema, no induration, and mild or no scaling
    • - Moderate: Moderate erythema, mild induration, and mild or no scaling
    • - Severe: Severe erythema, moderate to severe induration, and scaling of any degree

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Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Multicenter, Randomized, Double Blind, Parallel Group, Vehicle Controlled, Study of the Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 8 Weeks in Pediatric Subjects (2 to 12 Years of Age) With Mild to Moderate Plaque Psoriasis

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 10, 2014
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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