Combining triamcinolone and vitamin D for treating psoriasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the combined effectiveness of topical triamcinolone cream and oral vitamin D3 in patients with mild to moderate plaque psoriasis. Participants will initially receive triamcinolone for four weeks, followed by a random assignment to either vitamin D3 or a placebo for an additional twelve weeks. After this period, the study will transition to an open-label phase where all participants will receive vitamin D3 for another twelve weeks. The total duration of the study is 28 weeks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 and older
* Mild to severe plaque psoriasis (2% or greater Body Surface Area; Psoriasis Area and Severity Score of 2 or greater; Investigator Grade Assessment of mild-severe)

Exclusion Criteria:

* Currently taking medication that alters the normal ion balance of low-dose in blood.
* No calcium supplements 1 month prior to baseline (not including multivitamins).
* Unstable or uncontrolled illness, including but not limited to cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or psychiatric disease at screening.
* Abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect patient safety or data integrity.
* Not on systemic non-biologic therapy (including, but not limited to, oral psoralen plus ultraviolet A \[photochemotherapy (PUVA)\] light therapy; cyclosporine; corticosteroids; methotrexate; oral retinoids; apremilast; tofacitinib; mycophenolate mofetil; thioguanine; hydroxyurea; sirolimus; tacrolimus; azathioprine; leflunomide; fumaric acid derivatives; or 1, 25 dihydroxy vitamin D3 and analogues) within 28 days prior to baseline.
* No phototherapy (including either oral and topical PUVA light therapy, ultraviolet B, excimer laser, or self-treatment with tanning beds or therapeutic sunbathing) within 28 days prior to baseline.
* No topical treatment (including, but not limited to, corticosteroids \[upper mid strength or lower potency topical steroids are permitted on the intertriginous areas and face\], crisaborole, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, pimecrolimus, tacrolimus, emollients and other nonprescription topical products containing urea, \>3% salicylic acid, alpha- or beta-hydroxyl acids, or medicated shampoos \[for example those that contain \>3% salicylic acid, corticosteroids, coal tar, or vitamin D3 analogues\]) within 14 days prior to baseline.
* No biologic agents within 8 weeks or three half-lives, whichever is greater prior to baseline.
* History of renal impairment.
* History of renal stones.
* History of parathyroid abnormalities
* Osteoporosis
* History of severe arthritis
* Ongoing use of tanning bed or other UV device or excessive sunlight
* Unable to understand/complete informed consent.

Where it's running

• Wright State Physicians
  Fairborn, Ohio, United States Recruiting

Study contacts

• Principal investigator: Jeffrey B Travers, MD, PhD — Wright State University
• Study coordinator: Manager, Clinical Research Operations
• Email: pturesearch@wrightstatephysicians.org
• Phone: 937-245-7500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.