Plaque Psoriasis Study in Pediatric Subjects
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
1 other identifier
interventional
19
7 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2014
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 8, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
March 31, 2017
CompletedFebruary 18, 2021
March 1, 2017
1.3 years
July 8, 2014
February 15, 2017
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 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
Study Arms (2)
calcitriol ointment
EXPERIMENTALcalcitriol 3 mcg/g ointment
placebo
PLACEBO COMPARATORplacebo comparator
Interventions
Eligibility Criteria
You may qualify if:
- Male or female 2 to 12 years of age
- Clinical diagnosis of stable mild to moderate plaque psoriasis
You may not qualify if:
- Other forms of psoriasis
- Hypercalcemia
- Past history of kidney stones
- Vitamin D deficiency
- Other concomitant dermatological disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (34)
David Stoll, MD
Beverly Hills, California, 90212, United States
Center for Dermatology and Laser Surgery
Sacramento, California, 95819, United States
Dermatology Specialists Research
Louisville, Kentucky, 40202, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
RCMC Center for Dermatology at Linden Oaks
Rochester, New York, 14625, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Clinical Partners, LLC
Johnston, Rhode Island, 02919, United States
Dermatology and Laser Center of Charleston
Charleston, South Carolina, 29414, United States
DermResearch
Austin, Texas, 78759, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Jordan Valley Dermatology
West Jordan, Utah, 84088, United States
UCL Saint Luc
Brussels, 1200, Belgium
UZ Ghent
Ghent, 9000, Belgium
CHU de Liège
Liège, 4000, Belgium
Winnipeg Clinic, Dermatology Research
Winnipeg, Manitoba, r3con2, Canada
Universitätsklinikum Erlangen, Hautklinik
Erlangen, 91054, Germany
Praxis Dr.Beate Schwarz
Langenau, 89129, Germany
Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Technical University Munich
München, 80802, Germany
University of Tübingen
Tübingen, 72076, Germany
Heim Pál Gyermekkórház; Bőrgyógyászati Osztály
Budapest, 1089, Hungary
Pécsi Tudományegyetem; Bőr-, Nemikórtani és Onkodermatológiai Klinika
Pécs, 7632, Hungary
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ; Bőrgyógyászati és Allergológiai Klinika
Szeged, 6720, Hungary
PO G. Rodolico, AOU Policlinico Vittorio Emanuele
Catania, 95123, Italy
Padova University Hospital
Padua, 35128, Italy
University of Parma
Parma, 43126, Italy
Policlinico Tor Vergata
Rome, 00133, Italy
Hospital Universitari Germans Trias i Pujol
Badalona-Barcelona, 8916, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, 8950, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, 28702, Spain
Limitations and Caveats
Study terminated early due to slow enrollment.
Results Point of Contact
- Title
- Michael Graeber
- Organization
- Galderma
Study Officials
- STUDY DIRECTOR
Michael Graeber, MD
Galderma R&D, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2014
First Posted
July 10, 2014
Study Start
July 1, 2014
Primary Completion
November 1, 2015
Study Completion
January 1, 2016
Last Updated
February 18, 2021
Results First Posted
March 31, 2017
Record last verified: 2017-03