Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris

Inclusion Criteria:

Aged 12 to 17 years, inclusive.
Psoriasis vulgaris on the trunk and/or limbs which is:
amenable to topical treatment
of an extent of 5-30% of BSA
of at least a moderate severity
A serum cortisol concentration above 5 mcg/dL before ACTH-challenge and above 18 mcg/dL at 30 minutes after ACTH-challenge.
Albumin-corrected serum calcium and urinary calcium:creatinine ratio within the reference range.

Exclusion Criteria:

Serious allergy, serious asthma, or serious allergic skin rash.
A history of sensitivity to any medication.
PUVA or Grenz ray therapy, UVB therapy, systemic treatment with biological therapies, corticosteroids, or other therapies with an effect on psoriasis, topical treatment with corticosteroids or vitamin D analogues, treatment with enzymatic inductors, cytochrome P450 inhibitors, hypoglycemic sulfonamides, antidepressive medications, estrogen therapy, calcium supplements or vitamin D supplements.
Guttate, erythrodermic, exfoliative or pustular psoriasis.
Viral lesions of the skin, fungal or bacterial skin infections, ulcers or wounds.
Severe renal insufficiency, severe hepatic disorders, disorders of calcium metabolism associated with hypercalcemia, any cardiac condition or endocrine disorder.
Diabetes mellitus
Cushing's disease or Addison's disease.