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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00817219
First received: January 5, 2009
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Psoriasis Vulgaris
Drug: Calcipotriene plus betamethasone dipropionate ointment
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Adverse Drug Reactions [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    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".

  • Serum Cortisol Concentration of ≤18 Mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    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.

  • Serum Cortisol Concentration of ≤18 Mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    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.

  • Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: Yes ]
  • Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment. [ Time Frame: Baseline and 4 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • "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 ] [ Designated as safety issue: No ]
    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.

  • "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 ] [ Designated as safety issue: No ]
    The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe).

  • Percentage Change in PASI From Baseline to Week 4. [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • PASI 75 at Week 4. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • PASI 50 at Week 4. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 33
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TACLONEX ointment Drug: Calcipotriene plus betamethasone dipropionate ointment
Once daily application for 4 weeks

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

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817219

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

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00817219     History of Changes
Other Study ID Numbers: MCB 0501 INT
Study First Received: January 5, 2009
Results First Received: December 4, 2012
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Betamethasone
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone-17,21-dipropionate
Calcipotriene
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014