Combining triamcinolone and vitamin D for treating psoriasis
Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis
This study is testing if using a cream with triamcinolone and taking vitamin D3 can help people with mild to moderate psoriasis feel better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wright State University Academic / other |
| Drugs / interventions | tofacitinib, methotrexate |
| Locations | 1 site (Fairborn, Ohio) |
| Trial ID | NCT04036188 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with mild to severe plaque psoriasis affecting 2% or more of their body surface area.
Not a fit: Patients with unstable or uncontrolled illnesses or those currently taking medications that affect ion balance may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with psoriasis by leveraging the synergistic effects of triamcinolone and vitamin D3.
How similar studies have performed: While the specific combination of triamcinolone and vitamin D3 is novel, similar approaches using topical and systemic treatments have shown promise in managing psoriasis.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fairborn, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.