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

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.

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 (ie, psoriasis in the diaper area) can be included in the
BSA calculation for this age group.

Key Inclusion Criteria:

- Male or female subjects, ages 2 to 11 years, inclusive, at the time of consent

- For the maximum-use cohort:

A. ISGA of 3 or higher at Screening (see Appendix 2). Ages 7 to 11 - at least 10% total BSA
with some scalp involvement (See Appendix 1).

Ages 2 to 6 - at least 3% total BSA (napkin psoriasis included) with some scalp involvement
(See Appendix 1).

-For the general use cohort, an ISGA score of 2 or 3 at Screening with no BSA minimum.

Key Exclusion Criteria:

- Any inflammatory skin disease in the treatment area that may confound the evaluation
of the plaque psoriasis

- Current diagnosis of unstable forms of psoriasis in the treatment area, including
guttate, erythrodermic, exfoliative, or pustular psoriasis

- Use of any topical treatments that have a known beneficial effect on psoriasis,
including but not limited to corticosteroids, retinoids, vitamin D derivatives, coal
tar, tazarotene, medicated shampoos, or anthralin, within 2 weeks prior to enrollment

- Use of nonbiologic systemic antipsoriatic therapy (eg, corticosteroids, psoralen,
retinoids, methotrexate, cyclosporine, other immunosuppressive agents), biologic
therapy (eg, adalimumab, etanercept, golimumab, infliximab, ustekinumab), or
phototherapy (eg, psoralen and ultraviolet A [PUVA], ultraviolet B [UVB]) within 4
weeks prior to enrollment

- Use of or need for initiation of any nonpsoriatic therapy that might affect psoriasis
(including antimalarials, β-blockers, interferon, or lithium) within 4 weeks prior to
enrollment

- Use of medications that affect or change calcium and parathyroid hormone (PTH)
concentrations or interfere with the measurement of calcium or PTH concentrations
within 4 weeks prior to enrollment

- Known difficult venous access beyond that expected for subject age

- Average daily ingestion of more than 2000 mg of elemental calcium or more than 1000 IU
of vitamin D within 2 weeks prior to enrollment

- History of hypersensitivity, known allergy, or other adverse reaction to calcipotriene
or other vitamin D analogs or to any component of the study product

- Current or past history of hypercalcemia, vitamin D toxicity, severe renal
insufficiency, or severe hepatic disorders

- Use of any investigational therapy within 4 weeks prior to enrollment

- Pregnant or breast feeding female or females who do not use contraception

- Current immunosuppression

- Albumin-adjusted serum calcium at screening that is above the upper limit of normal