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

LEO Pharma

Status and phase

Completed

Phase 2

Conditions

Psoriasis Vulgaris

Treatments

Drug: Calcipotriene plus betamethasone dipropionate ointment

Study type

Interventional

Funder types

Industry

Identifiers

NCT00817219

MCB 0501 INT

Details and patient eligibility

About

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

Full 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.

Enrollment

33 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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.