Plaque Psoriasis Study in Pediatric Subjects

Completed · Phase 4 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT02186665

Run by

Galderma R&D

People needed

19

Starts

2014-07-01

Expected to finish

2016-01-01

Last updated by the study team

2021-02-18

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• David Stoll, MD — Beverly Hills, California, United States
• Center for Dermatology and Laser Surgery — Sacramento, California, United States
• Dermatology Specialists Research — Louisville, Kentucky, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• RCMC Center for Dermatology at Linden Oaks — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Clinical Partners, LLC — Johnston, Rhode Island, United States
• Dermatology and Laser Center of Charleston — Charleston, South Carolina, United States
• DermResearch — Austin, Texas, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• Clinical Trials of Texas — San Antonio, Texas, United States
• Jordan Valley Dermatology — West Jordan, Utah, United States
• UCL Saint Luc — Brussels, Belgium
• UZ Ghent — Ghent, Belgium
• CHU de Liège — Liège, Belgium
• Winnipeg Clinic, Dermatology Research — Winnipeg, Manitoba, Canada
• Universitätsklinikum Erlangen, Hautklinik — Erlangen, Germany
• Praxis Dr.Beate Schwarz — Langenau, Germany
• Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz — Mainz, Germany
• Technical University Munich — München, Germany
• University of Tübingen — Tübingen, Germany
• Heim Pál Gyermekkórház; Bőrgyógyászati Osztály — Budapest, Hungary
• Pécsi Tudományegyetem; Bőr-, Nemikórtani és Onkodermatológiai Klinika — Pécs, Hungary
• Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ; Bőrgyógyászati és Allergológiai Klinika — Szeged, Hungary
• PO G. Rodolico, AOU Policlinico Vittorio Emanuele — Catania, Italy

Full record on ClinicalTrials.gov

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