search
Back to results

Plaque Psoriasis Study in Pediatric Subjects

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
calcitriol ointment
placebo comparator
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • David Stoll, MD
  • Center for Dermatology and Laser Surgery
  • Dermatology Specialists Research
  • University of Mississippi Medical Center
  • Montefiore Medical Center
  • RCMC Center for Dermatology at Linden Oaks
  • Clinical Partners, LLC
  • Dermatology and Laser Center of Charleston
  • DermResearch
  • The University of Texas Health Science Center at Houston
  • Clinical Trials of Texas
  • Jordan Valley Dermatology
  • UCL Saint Luc
  • UZ Ghent
  • CHU de Liège
  • Winnipeg Clinic, Dermatology Research
  • Universitätsklinikum Erlangen, Hautklinik
  • Praxis Dr.Beate Schwarz
  • Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz
  • Technical University Munich
  • University of Tübingen
  • Heim Pál Gyermekkórház; Bőrgyógyászati Osztály
  • Pécsi Tudományegyetem; Bőr-, Nemikórtani és Onkodermatológiai Klinika
  • Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ; Bőrgyógyászati és Allergológiai Klinika
  • PO G. Rodolico, AOU Policlinico Vittorio Emanuele
  • Padova University Hospital
  • University of Parma
  • Policlinico Tor Vergata
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Sant Joan de Deu
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario Infanta Leonor
  • Hospital Universitario La Paz
  • Hospital Universitario Infanta Sofía

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

calcitriol ointment

placebo

Arm Description

calcitriol 3 mcg/g ointment

placebo comparator

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 8, 2014
Last Updated
February 16, 2021
Sponsor
Galderma R&D
search

1. Study Identification

Unique Protocol Identification Number
NCT02186665
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
calcitriol ointment
Arm Type
Experimental
Arm Description
calcitriol 3 mcg/g ointment
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo comparator
Intervention Type
Drug
Intervention Name(s)
calcitriol ointment
Intervention Type
Drug
Intervention Name(s)
placebo comparator
Primary Outcome Measure Information:
Title
Success of Investigator's Global Assessment (IGA)
Description
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
Time Frame
Baseline to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Graeber, MD
Organizational Affiliation
Galderma R&D, LLC
Official's Role
Study Director
Facility Information:
Facility Name
David Stoll, MD
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Center for Dermatology and Laser Surgery
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Dermatology Specialists Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
RCMC Center for Dermatology at Linden Oaks
City
Rochester
State/Province
New York
ZIP/Postal Code
14625
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Dermatology and Laser Center of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
DermResearch
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Jordan Valley Dermatology
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
UCL Saint Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU de Liège
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Winnipeg Clinic, Dermatology Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
r3con2
Country
Canada
Facility Name
Universitätsklinikum Erlangen, Hautklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Praxis Dr.Beate Schwarz
City
Langenau
ZIP/Postal Code
89129
Country
Germany
Facility Name
Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Technical University Munich
City
Munchen
ZIP/Postal Code
80802
Country
Germany
Facility Name
University of Tübingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Heim Pál Gyermekkórház; Bőrgyógyászati Osztály
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Pécsi Tudományegyetem; Bőr-, Nemikórtani és Onkodermatológiai Klinika
City
Pecs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ; Bőrgyógyászati és Allergológiai Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
PO G. Rodolico, AOU Policlinico Vittorio Emanuele
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Padova University Hospital
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
University of Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona-Barcelona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Hospital Sant Joan de Deu
City
Esplugues de Llobregat
ZIP/Postal Code
8950
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Infanta Sofía
City
San Sebastian de Los Reyes
ZIP/Postal Code
28702
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Plaque Psoriasis Study in Pediatric Subjects

We'll reach out to this number within 24 hrs