Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis

Completed · Phase 1

Conditions studied: Psoriasis

In brief

Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study evaluating calcipotriene foam, 0.005% in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. Subjects or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer twice a day on the body and scalp for up to 8 weeks. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated.

Key facts

Study ID

NCT01582932

Run by

Mayne Pharma International Pty Ltd

People needed

36

Starts

2013-04-01

Expected to finish

2018-08-01

Last updated by the study team

2019-01-22

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Investigational Site — Birmingham, Alabama, United States
• Investigational Site — Rogers, Arkansas, United States
• Investigational Site — Encino, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Santa Ana, California, United States
• Study site — Sherman Oaks, California, United States
• Investigational Site — Hollywood, Florida, United States
• Investigational Site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Investigational Site — Miami, Florida, United States
• Investigational Site — Tampa, Florida, United States
• Investigational Site — Alpharetta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Investigational Site — Marietta, Georgia, United States
• Investigational Site — Sandy Springs, Georgia, United States
• Investigational Site — Chicago, Illinois, United States
• Investigational Site — Plainfield, Indiana, United States
• Study site — Brighton, Massachusetts, United States
• Investigational Site — Farmington Hills, Michigan, United States
• Study site — Saint Joseph, Missouri, United States
• Investigational Site — St Louis, Missouri, United States
• Investigational Site — St Louis, Missouri, United States
• Investigational Site — New York, New York, United States
• Investigational Site — Chapel Hill, North Carolina, United States
• Investigational Site — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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