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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

January 5, 2009
January 7, 2013
July 2009
December 2011   (final data collection date for primary outcome measure)
  • 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 ]
Adverse reactions, serum cortisol after ACTH challenge, serum calcium, urinary calcium:creatinine ratio [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00817219 on ClinicalTrials.gov Archive Site
  • "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.
Patients with clear or almost clear disease, change in PASI [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Psoriasis Vulgaris
Drug: Calcipotriene plus betamethasone dipropionate ointment
Once daily application for 4 weeks
Experimental: TACLONEX ointment
Intervention: Drug: Calcipotriene plus betamethasone dipropionate ointment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00817219
MCB 0501 INT
No
LEO Pharma
LEO Pharma
Not Provided
Principal Investigator: Amy S Paller, MD Northwestern University's Feinberg School of Medicine
LEO Pharma
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP