Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
Completed · Phase 2
Conditions studied: Psoriasis Vulgaris
In brief
The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris.
Key facts
- Study ID
- NCT00817219
- Run by
- LEO Pharma
- People needed
- 33
- Starts
- 2009-07-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2025-03-12
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Center for Dermatology Clinical Research — Fremont, California, United States
- University of California at San Diego/Rady Children's Hospital — San Diego, California, United States
- Ameriderm Research — Maitland, Florida, United States
- Northwestern University's Feinberg School of Medicine — Chicago, Illinois, United States
- Arlington Research Center — Arlington, Texas, United States
- University of Texas-Dermatology — Houston, Texas, United States
- Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
- DBA Dermatology Associates — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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