Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This is a multicenter, open-label, Phase 1 study in a total of 75 pediatric subjects, ages 2
      to 11 years, inclusive, with mild or moderate plaque psoriasis.

      The study will enroll sufficient subjects with plaque psoriasis and an ISGA score of mild to
      moderate (score of 2 or 3) at Baseline to ensure 50 evaluable subjects in a general use
      cohort.

      In addition, a sufficient number of subjects with moderate plaque psoriasis will be enrolled
      to ensure 25 evaluable subjects in a 'maximum-use' cohort that have:

      A. At least 10% total BSA with some scalp involvement (15 evaluable subjects ages 7 to 11
      years) or B. At least 3% total BSA with some scalp involvement (10 evaluable subjects ages 2
      to 6 years). "Napkin" psoriasis (psoriasis in the diaper area) can be included in the BSA
      calculation for this age group.

      Subjects or their caregivers will apply a thin layer of study product twice a day to the
      treatment areas for 8 weeks. Any new psoriatic lesions appearing in treatment areas during
      the treatment period should also be treated with study product. Safety assessments (adverse
      event and serious adverse event query) will occur at all study visits. Treatment effect
      assessments, urine calcium metabolism assessments, and application site tolerability
      assessments will be performed for all subjects at all in-clinic visits. A blood sample will
      be taken from all subjects at Screening for evaluation of pharmacodynamic (PD) and 2,5-OH
      vitamin D levels, an additional blood draw for PD parameters will be taken at Week 2 for the
      maximum-use cohort only. Blood sampling for pharmacokinetic (PK) measurements will be
      performed in the maximum-use cohort at Screening and Week 2.
    

Intervention name(s): Calcipotriene 0.005% Foam
Intervention type(s): Drug
Intervention description(s): All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face).
Other intervention name(s): Sorilux
Intervention MeSH terms: Calcipotriene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: plaque psoriasis; pediatric; mild; moderate