Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
GlaxoSmithKline Mayne Pharma International Pty Ltd