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

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Calcipotriene plus betamethasone dipropionate ointment
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Dermatology Clinical Research
  • University of California at San Diego/Rady Children's Hospital
  • Ameriderm Research
  • Northwestern University's Feinberg School of Medicine
  • Arlington Research Center
  • University of Texas-Dermatology
  • Virginia Clinical Research, Inc.
  • DBA Dermatology Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TACLONEX ointment

Arm Description

Outcomes

Primary Outcome Measures

Adverse Drug Reactions
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
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
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
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.

Secondary Outcome Measures

"Controlled Disease"(i.e., "Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity at 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.
"Controlled Disease"(i.e., "Clear" or "Very Mild") According to the Patient's Global Assessment of Disease Severity at Week 4.
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.
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.
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.
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.

Full Information

First Posted
January 5, 2009
Last Updated
March 25, 2015
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00817219
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TACLONEX ointment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Calcipotriene plus betamethasone dipropionate ointment
Intervention Description
Once daily application for 4 weeks
Primary Outcome Measure Information:
Title
Adverse Drug Reactions
Description
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".
Time Frame
Week 4
Title
Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment
Description
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.
Time Frame
Week 4
Title
Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment
Description
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.
Time Frame
Week 4
Title
Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment
Time Frame
Baseline and 4 weeks
Title
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.
Time Frame
Baseline and 4 Weeks
Secondary Outcome Measure Information:
Title
"Controlled Disease"(i.e., "Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity at Week 4.
Description
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.
Time Frame
Week 4
Title
"Controlled Disease"(i.e., "Clear" or "Very Mild") According to the Patient's Global Assessment of Disease Severity at Week 4.
Description
The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe).
Time Frame
Week 4
Title
Percentage Change in PASI From Baseline to Week 4.
Description
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.
Time Frame
Baseline and 4 weeks
Title
PASI 75 at Week 4.
Description
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.
Time Frame
4 weeks
Title
PASI 50 at Week 4.
Description
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.
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy S Paller, MD
Organizational Affiliation
Northwestern University's Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Dermatology Clinical Research
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
University of California at San Diego/Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ameriderm Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Northwestern University's Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2997
Country
United States
Facility Name
Arlington Research Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
University of Texas-Dermatology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
DBA Dermatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

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

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