Clinical trial NCT02186665: Plaque Psoriasis Study in Pediatric Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 19
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Success of Investigator's Global Assessment (IGA)
timeFrame: Baseline to Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: David Stoll, MD
state: California
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
state: California
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: RCMC Center for Dermatology at Linden Oaks
state: New York
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Charleston
country: United States
facility: Dermatology and Laser Center of Charleston
state: South Carolina
city: Austin
country: United States
facility: DermResearch
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: West Jordan
country: United States
facility: Jordan Valley Dermatology
state: Utah
city: Brussel
country: Belgium
facility: UCL Saint Luc
city: Ghent
country: Belgium
facility: UZ Ghent
city: Liege
country: Belgium
facility: CHU de Liège
city: Winnipeg
country: Canada
facility: Winnipeg Clinic, Dermatology Research
state: Manitoba
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Hautklinik
city: Langenau
country: Germany
facility: Praxis Dr.Beate Schwarz
city: Mainz
country: Germany
facility: Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz
city: Munchen
country: Germany
facility: Technical University Munich
city: Tubingen
country: Germany
facility: University of Tübingen
city: Budapest
country: Hungary
facility: Heim Pál Gyermekkórház; Bőrgyógyászati Osztály
city: Pecs
country: Hungary
facility: Pécsi Tudományegyetem; Bőr-, Nemikórtani és Onkodermatológiai Klinika
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ; Bőrgyógyászati és Allergológiai Klinika
city: Catania
country: Italy
facility: PO G. Rodolico, AOU Policlinico Vittorio Emanuele
city: Padova
country: Italy
facility: Padova University Hospital
city: Parma
country: Italy
facility: University of Parma
city: Rome
country: Italy
facility: Policlinico Tor Vergata
city: Badalona-Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: San Sebastian de Los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofía
Study officials:
affiliation: Galderma R&D, LLC
name: Michael Graeber, MD
role: STUDY_DIRECTOR
References: