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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Psoriasis Vulgaris	Drug: Calcipotriene plus betamethasone dipropionate ointment	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	33 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
Study Start Date :	July 2009
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	December 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: TACLONEX ointment	Drug: Calcipotriene plus betamethasone dipropionate ointment; Once daily application for 4 weeks

Outcome Measures

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Primary Outcome Measures :

1. Adverse Drug Reactions [ Time Frame: Week 4 ]
   The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as "not related".
2. Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment [ Time Frame: Week 4 ]
   The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.
3. Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment [ Time Frame: Week 4 ]
   The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.
4. Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment [ Time Frame: Baseline and 4 weeks ]
5. Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment. [ Time Frame: Baseline and 4 Weeks ]

Secondary Outcome Measures :

1. "Controlled Disease"(i.e., "Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity at Week 4. [ Time Frame: Week 4 ]
   The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). This assessment represented the average lesion severity on the trunk and limbs.
2. "Controlled Disease"(i.e., "Clear" or "Very Mild") According to the Patient's Global Assessment of Disease Severity at Week 4. [ Time Frame: Week 4 ]
   The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe).
3. Percentage Change in PASI From Baseline to Week 4. [ Time Frame: Baseline and 4 weeks ]
   PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.
4. PASI 75 at Week 4. [ Time Frame: 4 weeks ]
   PASI 75 is at least 75% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.
5. PASI 50 at Week 4. [ Time Frame: Week 4 ]
   PASI 50 is at least 50% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator'sassessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, California
Center for Dermatology Clinical Research
Fremont, California, United States, 94538
University of California at San Diego/Rady Children's Hospital
San Diego, California, United States, 92123
United States, Florida
Ameriderm Research
Maitland, Florida, United States, 32751
United States, Illinois
Northwestern University's Feinberg School of Medicine
Chicago, Illinois, United States, 60611-2997
United States, Texas
Arlington Research Center
Arlington, Texas, United States, 76011
University of Texas-Dermatology
Houston, Texas, United States, 77030
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
United States, Washington
DBA Dermatology Associates
Seattle, Washington, United States, 98101

Sponsors and Collaborators

LEO Pharma

Investigators

Principal Investigator:	Amy S Paller, MD	Northwestern University's Feinberg School of Medicine

More Information

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Additional Information:

Clinical Trials at LEO Pharma 

Responsible Party:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00817219 History of Changes
Other Study ID Numbers:	MCB 0501 INT
First Posted:	January 6, 2009
Results First Posted:	January 7, 2013
Last Update Posted:	April 14, 2015
Last Verified:	March 2015

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone; Betamethasone Valerate; Betamethasone sodium phosphate; Calcipotriene	Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents