Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
1 other identifier
interventional
33
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2009
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 6, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
January 7, 2013
CompletedMarch 12, 2025
March 1, 2015
2.4 years
January 5, 2009
December 4, 2012
February 21, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
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".
Week 4
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.
Week 4
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.
Week 4
Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment
Baseline and 4 weeks
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.
Baseline and 4 Weeks
Secondary Outcomes (5)
"Controlled Disease"(i.e., "Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity at Week 4.
Week 4
"Controlled Disease"(i.e., "Clear" or "Very Mild") According to the Patient's Global Assessment of Disease Severity at Week 4.
Week 4
Percentage Change in PASI From Baseline to Week 4.
Baseline and 4 weeks
PASI 75 at Week 4.
4 weeks
PASI 50 at Week 4.
Week 4
Study Arms (1)
TACLONEX ointment
EXPERIMENTALInterventions
Once daily application for 4 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (8)
Center for Dermatology Clinical Research
Fremont, California, 94538, United States
University of California at San Diego/Rady Children's Hospital
San Diego, California, 92123, United States
Ameriderm Research
Maitland, Florida, 32751, United States
Northwestern University's Feinberg School of Medicine
Chicago, Illinois, 60611-2997, United States
Arlington Research Center
Arlington, Texas, 76011, United States
University of Texas-Dermatology
Houston, Texas, 77030, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
DBA Dermatology Associates
Seattle, Washington, 98101, United States
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Malin Järnkrants
- Organization
- LEO Pharma A/S
Study Officials
- PRINCIPAL INVESTIGATOR
Amy S Paller, MD
Northwestern University's Feinberg School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 6, 2009
Study Start
July 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 12, 2025
Results First Posted
January 7, 2013
Record last verified: 2015-03
Data Sharing
- IPD Sharing
- Will not share