Status:
COMPLETED
Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
Lead Sponsor:
LEO Pharma
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
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% o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00817219
Start Date
July 1 2009
End Date
December 1 2011
Last Update
March 12 2025
Active Locations (8)
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1
Center for Dermatology Clinical Research
Fremont, California, United States, 94538
2
University of California at San Diego/Rady Children's Hospital
San Diego, California, United States, 92123
3
Ameriderm Research
Maitland, Florida, United States, 32751
4
Northwestern University's Feinberg School of Medicine
Chicago, Illinois, United States, 60611-2997