NCT04036188 Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis
| NCT ID | NCT04036188 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Wright State University |
| Condition | Plaque Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2019-10-16 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2019-10-16 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
These studies are designed to assess the synergistic efficacy of topical 0.1% triamcinolone cream paired with 40,000 IU of oral vitamin D3 daily in treating mild to moderate psoriasis. The study is designed to have all subjects treated with triamcinolone cream (TAC) for 4 weeks, then will be randomized 1:1 into vitamin D3 or placebo for an additional 12 weeks. At that time, the study will become open-label and all subjects will be placed on (or continue) vitamin D3 for an additional 12 weeks. The study will take place over 28 weeks total.
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.
Contact & Investigator
Jeffrey B Travers, MD, PhD
PRINCIPAL INVESTIGATOR
Wright State University
Frequently Asked Questions
Who can join the NCT04036188 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Plaque Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04036188 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04036188 currently recruiting?
Yes, NCT04036188 is actively recruiting participants. Contact the research team at pturesearch@wrightstatephysicians.org for enrollment information.
Where is the NCT04036188 trial being conducted?
This trial is being conducted at Fairborn, United States.
Who is sponsoring the NCT04036188 clinical trial?
NCT04036188 is sponsored by Wright State University. The principal investigator is Jeffrey B Travers, MD, PhD at Wright State University. The trial plans to enroll 24 participants.
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