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Plaque Psoriasis Study in Pediatric Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02186665
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : March 31, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: calcitriol ointment Drug: placebo comparator Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Calcitriol

Arm Intervention/treatment
Experimental: calcitriol ointment
calcitriol 3 mcg/g ointment
Drug: calcitriol ointment
Placebo Comparator: placebo
placebo comparator
Drug: placebo comparator



Primary Outcome Measures :
  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

    1. - Almost Clear: Just perceptible erythema, no induration, and no scaling
    2. - Mild: Mild erythema, no induration, and mild or no scaling
    3. - Moderate: Moderate erythema, mild induration, and mild or no scaling
    4. - Severe: Severe erythema, moderate to severe induration, and scaling of any degree



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186665


  Show 34 Study Locations
Sponsors and Collaborators
Galderma
Investigators
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Study Director: Michael Graeber, MD Galderma R&D, LLC

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Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT02186665     History of Changes
Other Study ID Numbers: RD.06.SPR.18132
First Posted: July 10, 2014    Key Record Dates
Results First Posted: March 31, 2017
Last Update Posted: May 9, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Calcitriol
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents