A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Calcipotriene Foam, 0.005%, Applied Under Maximal-Use Conditions in Adolescent Subjects (Ages 12 to 16 Years) With Plaque Psoriasis

NCT01563068 Phase 1 COMPLETED

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

Details

Lead sponsor	Mayne Pharma International Pty Ltd
Phase	Phase 1
Status	COMPLETED
Enrolment	18
Start date	2012-04
Completion	2015-08

Conditions

• Psoriasis

Interventions

• Calcipotriene 0.005% Foam

Primary outcomes

• Effect of calcium metabolism — Up to 3 Weeks
  determine albumin-adjusted calcium, iPTH, alkaline phosphatase, and phosphorus

Countries

United States