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

Condition(s) targeted: Psoriasis Vulgaris

Intervention: Calcipotriene plus betamethasone dipropionate ointment (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Amy S Paller, MD, Principal Investigator, Affiliation: Northwestern University's Feinberg School of Medicine

Overall contact:
Adrian Bibby, BSc, Phone: +44 1844 276224, Email: adrian.bibby@leo-pharma.com

The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris.

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

Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Adverse reactions, serum cortisol after ACTH challenge, serum calcium, urinary calcium:creatinine ratio

Secondary outcome: Patients with clear or almost clear disease, change in PASI

Detailed description: TACLONEX ointment has marketing approval in many countries for the treatment of psoriasis vulgaris in adults. No studies have been conducted in patients less than 18 years of age. However, about 25% of affected individuals are diagnosed between 10 and 19 years of age, hence psoriasis is also prevalent in the adolescent age group (12-17 years).

All patients will receive TACLONEX. To evaluate the safety of TACLONEX ointment, all adverse events will be recorded. In addition, any systemic absorption of the active components, betamethasone dipropionate and calcipotriene, will be evaluated by assessing adrenal function (using CORTROSYN™ test) and calcium metabolism (by measuring serum calcium and the urinary calcium: creatinine ratio), respectively.

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Adrian Bibby, BSc, Phone: +44 1844 276224, Email: adrian.bibby@leo-pharma.com

Northwestern University's Feinberg School of Medicine, Chicago, Illinois 60611-2997, United States; Recruiting
Phone: 312-695-3721, Email: apaller@nmff.org
Amy S Paller, MD, Principal Investigator

Starting date: July 2009
Last updated: March 5, 2010