Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

Launched by WRIGHT STATE UNIVERSITY · Jul 25, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the combined effects of a topical cream called triamcinolone and an oral supplement of vitamin D3 in treating mild to moderate plaque psoriasis, a skin condition that causes red, scaly patches. Participants in the study will first use the triamcinolone cream for four weeks. After that, they will be randomly divided into two groups: one will continue with vitamin D3, while the other will receive a placebo (a treatment with no active ingredients) for an additional 12 weeks. Following this period, everyone will have access to vitamin D3 for another 12 weeks. The entire study will last for a total of 28 weeks.

To be eligible for this trial, participants need to be at least 18 years old and have mild to severe plaque psoriasis. However, certain individuals may not qualify, such as those currently taking medications that affect calcium levels, those with unstable health conditions, or those who have used specific treatments for their psoriasis recently. This study is currently recruiting participants, and it welcomes individuals of all genders. If you're considering joining, you can expect regular check-ins to monitor your progress and response to the treatment.

Gender

ALL

Eligibility criteria

• 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.