Safety, Tolerability, PD & PK of Calcipotriene 0.005% Foam, Under Maximal Use in 12-16 Year Olds With Plaque Psoriasis
Status:
Completed
Trial end date:
2015-08-01
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 in which adolescent subjects (ages 12 to 16 years, inclusive) or their
primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer to treatment areas
of the body and scalp, excluding the face, under maximal use conditions, twice a day for 14
days and once on Day 15. The safety, tolerability, pharmacodynamics, and pharmacokinetics of
calcipotriene will be evaluated
Phase:
Phase 1
Details
Lead Sponsor:
Mayne Pharma International Pty Ltd Stiefel, a GSK Company