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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02186665
Other study ID # RD.06.SPR.18132
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 2014
Est. completion date January 2016

Study information

Verified date March 2017
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date January 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group 2 Years to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
calcitriol ointment

placebo comparator


Locations

Country Name City State
Belgium UCL Saint Luc Brussel
Belgium UZ Ghent Ghent
Belgium CHU de Liège Liege
Canada Winnipeg Clinic, Dermatology Research Winnipeg Manitoba
Germany Universitätsklinikum Erlangen, Hautklinik Erlangen
Germany Praxis Dr.Beate Schwarz Langenau
Germany Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz Mainz
Germany Technical University Munich Munchen
Germany University of Tübingen Tubingen
Hungary Heim Pál Gyermekkórház; Borgyógyászati Osztály Budapest
Hungary Pécsi Tudományegyetem; Bor-, Nemikórtani és Onkodermatológiai Klinika Pecs
Hungary Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ; Borgyógyászati és Allergológiai Klinika Szeged
Italy PO G. Rodolico, AOU Policlinico Vittorio Emanuele Catania
Italy Padova University Hospital Padova
Italy University of Parma Parma
Italy Policlinico Tor Vergata Rome
Spain Hospital Universitari Germans Trias i Pujol Badalona-Barcelona
Spain Hospital Sant Joan de Deu Esplugues de Llobregat
Spain Hospital General Universitario Gregorio Marañón Madrid
Spain Hospital Universitario Infanta Leonor Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Infanta Sofía San Sebastian de Los Reyes
United States DermResearch Austin Texas
United States David Stoll, MD Beverly Hills California
United States Montefiore Medical Center Bronx New York
United States Dermatology and Laser Center of Charleston Charleston South Carolina
United States The University of Texas Health Science Center at Houston Houston Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States Clinical Partners, LLC Johnston Rhode Island
United States Dermatology Specialists Research Louisville Kentucky
United States RCMC Center for Dermatology at Linden Oaks Rochester New York
United States Center for Dermatology and Laser Surgery Sacramento California
United States Clinical Trials of Texas San Antonio Texas
United States Jordan Valley Dermatology West Jordan Utah

Sponsors (1)

Lead Sponsor Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Hungary,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success of Investigator's Global Assessment (IGA) 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
Baseline to Week 8
See also
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