Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Completed · Phase 4
Conditions studied: Psoriasis Vulgaris
In brief
The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis.
Key facts
- Study ID
- NCT02125279
- Run by
- Galderma R&D
- People needed
- 54
- Starts
- 2014-05-01
- Expected to finish
- 2018-05-01
- Last updated by the study team
- 2021-02-18
Who can join
Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female 2 to 16 years and 11 months 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
- Johnson Dermatology — Fort Smith, Arkansas, United States
- Northwest Arkansas Clinical Trials Center, PLLC — Rogers, Arkansas, United States
- Advanced Skincare Surgery & Medcenter — Burbank, California, United States
- University of South Florida — Tampa, Florida, United States
- Shideler Clinical Research Center — Carmel, Indiana, United States
- Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
- Montefiore Medical Center — New York, New York, United States
- Arlington Research Center for Dermatology — Arlington, Texas, United States
- UZ Gent Dermatology Department — Ghent, Belgium
- Lynderm Research Inc. — Markham, Ontario, Canada
- CHU Sainte-Justine — Montreal, Quebec, Canada
- Charité Universitätsmedizin Berlin — Berlin, Germany
- University Hospital Carl Gustav Carus — Dresden, Germany
- Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz — Mainz, Germany
- Padova University Hospital — Padova, Italy
- University of Parma — Parma, Italy
Full record on ClinicalTrials.gov
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