Clinical trial NCT00817219: Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
Official title: Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2009-01-06
Enrollment: 33
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Adverse Drug Reactions
timeFrame: Week 4
measure: Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment
timeFrame: Week 4
measure: Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment
timeFrame: Week 4
measure: Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment
timeFrame: Baseline and 4 weeks
measure: Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.
timeFrame: Baseline and 4 Weeks
Secondary outcomes:
measure: "Controlled Disease"(i.e., "Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity at Week 4.
timeFrame: Week 4
measure: "Controlled Disease"(i.e., "Clear" or "Very Mild") According to the Patient's Global Assessment of Disease Severity at Week 4.
timeFrame: Week 4
measure: Percentage Change in PASI From Baseline to Week 4.
timeFrame: Baseline and 4 weeks
measure: PASI 75 at Week 4.
timeFrame: 4 weeks
measure: PASI 50 at Week 4.
timeFrame: Week 4
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: San Diego
country: United States
facility: University of California at San Diego/Rady Children's Hospital
state: California
city: Maitland
country: United States
facility: Ameriderm Research
state: Florida
city: Chicago
country: United States
facility: Northwestern University's Feinberg School of Medicine
state: Illinois
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: Houston
country: United States
facility: University of Texas-Dermatology
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Seattle
country: United States
facility: DBA Dermatology Associates
state: Washington
Study officials:
affiliation: Northwestern University's Feinberg School of Medicine
name: Amy S Paller, MD
role: PRINCIPAL_INVESTIGATOR
References: