Plaque Psoriasis Study in Pediatric Subjects

NCT ID: NCT02186665

Last Updated: 2021-02-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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calcitriol ointment

calcitriol 3 mcg/g ointment

Group Type EXPERIMENTAL

calcitriol ointment

Intervention Type DRUG

placebo

placebo comparator

Group Type PLACEBO_COMPARATOR

placebo comparator

Intervention Type DRUG

Interventions

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calcitriol ointment

Intervention Type DRUG

placebo comparator

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Graeber, MD

Role: STUDY_DIRECTOR

Galderma R&D, LLC

Locations

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David Stoll, MD

Beverly Hills, California, United States

Site Status

Center for Dermatology and Laser Surgery

Sacramento, California, United States

Site Status

Dermatology Specialists Research

Louisville, Kentucky, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

RCMC Center for Dermatology at Linden Oaks

Rochester, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Clinical Partners, LLC

Johnston, Rhode Island, United States

Site Status

Dermatology and Laser Center of Charleston

Charleston, South Carolina, United States

Site Status

DermResearch

Austin, Texas, United States

Site Status

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Clinical Trials of Texas

San Antonio, Texas, United States

Site Status

Jordan Valley Dermatology

West Jordan, Utah, United States

Site Status

UCL Saint Luc

Brussels, , Belgium

Site Status

UZ Ghent

Ghent, , Belgium

Site Status

CHU de Liège

Liège, , Belgium

Site Status

Winnipeg Clinic, Dermatology Research

Winnipeg, Manitoba, Canada

Site Status

Universitätsklinikum Erlangen, Hautklinik

Erlangen, , Germany

Site Status

Praxis Dr.Beate Schwarz

Langenau, , Germany

Site Status

Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Site Status

Technical University Munich

München, , Germany

Site Status

University of Tübingen

Tübingen, , Germany

Site Status

Heim Pál Gyermekkórház; Bőrgyógyászati Osztály

Budapest, , Hungary

Site Status

Pécsi Tudományegyetem; Bőr-, Nemikórtani és Onkodermatológiai Klinika

Pécs, , Hungary

Site Status

Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ; Bőrgyógyászati és Allergológiai Klinika

Szeged, , Hungary

Site Status

PO G. Rodolico, AOU Policlinico Vittorio Emanuele

Catania, , Italy

Site Status

Padova University Hospital

Padua, , Italy

Site Status

University of Parma

Parma, , Italy

Site Status

Policlinico Tor Vergata

Rome, , Italy

Site Status

Hospital Universitari Germans Trias i Pujol

Badalona-Barcelona, , Spain

Site Status

Hospital Sant Joan de Deu

Esplugues de Llobregat, , Spain

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Hospital Universitario Infanta Leonor

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, , Spain

Site Status

Countries

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United States Belgium Canada Germany Hungary Italy Spain

Other Identifiers

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RD.06.SPR.18132

Identifier Type: -

Identifier Source: org_study_id

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