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

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: NCT02125279
Recruitment Status : Active, not recruiting
First Posted : April 29, 2014
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Galderma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: Calcitriol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Open Label Uncontrolled Study of the Long Term Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 26 Weeks in Pediatric Subjects (2 to 16 Years and 11 Months of Age) With Mild to Moderate Plaque Psoriasis
Study Start Date : May 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Calcitriol

Arm Intervention/treatment
Experimental: Calcitriol ointment Drug: Calcitriol



Primary Outcome Measures :
  1. Laboratory parameters related to calcium metabolism after 26 weeks of topical treatment with Calcitriol 3 mcg/g [ Time Frame: Week 26 ]

    Proportion of subjects with serum albumin-adjusted calcium higher than the upper normal limit and/or Parathyroid hormone (PTH) levels below the lower limit of normal.

    Incidence of urolithiasis




Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02125279


Locations
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United States, Arizona
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, United States, 85255
United States, Arkansas
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, United States, 72758
United States, California
David Stoll, MD
Beverly Hills, California, United States, 90212
Advanced Skincare Surgery & Medcenter
Burbank, California, United States, 91505
Advanced Dermatology and Skin Cancer Specialist
Temecula, California, United States, 92592
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
United States, Indiana
Shideler Clinical Research Center
Carmel, Indiana, United States, 46032
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States, 46256
United States, New York
Montefiore Medical Center
New York, New York, United States, 10467
United States, Texas
Arlington Research Center for Dermatology
Arlington, Texas, United States, 76011
Westlake Dermatology Clinical Research Center
Austin, Texas, United States, 78746
West Houston Dermatology
Houston, Texas, United States, 77082
Belgium
UCL Saint-Luc
Bruxelles, Belgium, 1200
UZ Gent Dermatology Department
Gent, Belgium, 9000
Canada, Ontario
Lynderm Research Inc.
Markham, Ontario, Canada, L3P1X2
Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T1C5
Germany
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
University Hospital Carl Gustav Carus
Dresden, Germany, 01307
Universitätsklinikum Erlangen, Hautklinik
Erlangen, Germany, 91054
Praxis Dr.Beate Schwarz
Langenau, Germany, 89129
Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Italy
PO G. Rodolico, AOU Policlinico Vittorio Emanuele
Catania, Italy, 85123
Padova University Hospital
Padova, Italy, 35128
University of Parma
Parma, Italy, 43126
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: NCT02125279     History of Changes
Other Study ID Numbers: RD.06.SPR.18131
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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