Plaque Psoriasis Study in Pediatric Subjects

February 16, 2021 updated by: Galderma R&D

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1200
        • UCL Saint Luc
      • Ghent, Belgium, 9000
        • UZ Ghent
      • Liege, Belgium, 4000
        • CHU de Liege
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, r3con2
        • Winnipeg Clinic, Dermatology Research
  • Germany
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen, Hautklinik
      • Langenau, Germany, 89129
        • Praxis Dr.Beate Schwarz
      • Mainz, Germany, 55131
        • Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz
      • Munchen, Germany, 80802
        • Technical University Munich
      • Tubingen, Germany, 72076
        • University of Tubingen
  • Hungary
      • Budapest, Hungary, 1089
        • Heim Pál Gyermekkórház; Bőrgyógyászati Osztály
      • Pecs, Hungary, 7632
        • Pécsi Tudományegyetem; Bőr-, Nemikórtani és Onkodermatológiai Klinika
      • Szeged, Hungary, 6720
        • Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ; Bőrgyógyászati és Allergológiai Klinika
  • Italy
      • Catania, Italy, 95123
        • PO G. Rodolico, AOU Policlinico Vittorio Emanuele
      • Padova, Italy, 35128
        • Padova University Hospital
      • Parma, Italy, 43126
        • University of Parma
      • Rome, Italy, 00133
        • Policlinico Tor Vergata
  • Spain
      • Badalona-Barcelona, Spain, 8916
        • Hospital Universitari Germans Trias I Pujol
      • Esplugues de Llobregat, Spain, 8950
        • Hospital Sant Joan de Deu
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
      • San Sebastian de Los Reyes, Spain, 28702
        • Hospital Universitario Infanta Sofía
  • United States
    • California
      • Beverly Hills, California, United States, 90212
        • David Stoll, MD
      • Sacramento, California, United States, 95819
        • Center for Dermatology and Laser Surgery
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Dermatology Specialists Research
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Rochester, New York, United States, 14625
        • RCMC Center for Dermatology at Linden Oaks
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Dermatology and Laser Center of Charleston
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
    • Utah
      • West Jordan, Utah, United States, 84088
        • Jordan Valley Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
placebo comparator
Drug: placebo comparator
Experimental: calcitriol ointment
calcitriol 3 mcg/g ointment
Drug: calcitriol ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of Investigator's Global Assessment (IGA)
Time Frame: Baseline to Week 8

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

  1. - Almost Clear: Just perceptible erythema, no induration, and no scaling
  2. - Mild: Mild erythema, no induration, and mild or no scaling
  3. - Moderate: Moderate erythema, mild induration, and mild or no scaling
  4. - Severe: Severe erythema, moderate to severe induration, and scaling of any degree
Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Study Director: Michael Graeber, MD, Galderma R&D, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.06.SPR.18132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Plaque Psoriasis

Clinical Trials on placebo comparator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe