Plaque Psoriasis Study in Pediatric Subjects

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186665
• Other study ID #: RD.06.SPR.18132
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

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