Psoriasis Clinical Trials

Thank you for your interest in our Psoriasis Clinical Trial.  Please read the following information about the study to see if you qualify.
  
Inclusion Criteria: (Must be able to answer “YES” to the following)

• Age 18 years or above
• Male or Female
• Clinical diagnosis of stable plaque psoriasis vulgaris of at least 6 months duration involving the non-scalp regions of the body (trunk and/or limbs) amenable to treatment with a maximum of 100 g of topical medication per week.
• Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomized partner. The patients must have used the contraceptive method continually for at least 1 month prior to pregnancy test, and must continue using the contraceptive method for at least 1 week after the last application of study medication. A female is defined as not of child-bearing potential is she is postmenopausal (12 months with no menses without an alternative medical cause), or surgically sterile (tubal ligation/section, hysterectomy or bilateral ovariectomy).
• Must be willing to come into the office for 6 visits of the course of 8 weeks.
• Must be willing to apply a topical medication every day for 8 weeks.

Exclusion Criteria:  (Must be able to answer “NO” to the following)

• Systemic treatment with biological therapies whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomization:
  
  

  Entanercept	within 4 weeks prior to randomization
  Adalimumab, Alefacept, Infliximab	within 2 months prior to randomization
  Ustekinumab	within 4 months prior to randomization
  Experimental products	within 4 weeks/5 half lives (whichever is longer) prior to randomization

  
  
• Systemic treatment with all other therapies with possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, cyclosporine and other immunosupprresants) within 4 weeks prior to randomization.
• PUVA or Grenz ray therapy within 4 weeks prior to randomization.
• UVB therapy within 2 weeks prior to randomization.
• Any topical treatment of the trunk and/or limbs (except for emollients) within 2 weeks prior to randomization.
• Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with class 1-5 corticosteroids or vitamin D analogues within 2 weeks prior to randomization.
• Topical treatment for other relevant skin disorders (e.g. scalp psoriasis) with class 1-5 corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomization.
• Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, anti-malarials, lithium, ACE inhibitors) during the study.
• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
• Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicaella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, acne rosacea, ulcers and wounds.
• Known or suspected disorders of calcium metabolism associated with hypocalcaemia.
• Known or suspected severe renal insufficiency or severe hepatic disorders.
• Known or suspected hypersensitivity to component(s) of the investigational products.
• Current participation in any other interventional clinical study.
• Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the 4-week period prior to randomization or longer, if the class of substance required a longer washout as defined above (e.g. biological treatments).
• Planned excessive exposure to the sun during the study that may affect the psoriasis vulgaris.
• Females who are pregnant, have a positive pregnancy test at Day 0 (Visit 1), or are breast feeding.
• If you think that you would be a good candidate for this study, please click on the following link to register online. A staff member will be calling you to schedule your screening visit. Please note, there is compensation for your time and travel of $25 per visit. Thank you for your interest in University Clinical Trials.

Register here