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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TACLONEX ointment

Group Type EXPERIMENTAL

Calcipotriene plus betamethasone dipropionate ointment

Intervention Type DRUG

Once daily application for 4 weeks

Interventions

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Calcipotriene plus betamethasone dipropionate ointment

Once daily application for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No