Status:
RECRUITING
Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis
Lead Sponsor:
Wright State University
Conditions:
Plaque Psoriasis
Vitamin D3
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 de...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04036188
Start Date
October 16 2019
End Date
December 1 2026
Last Update
January 27 2025
Active Locations (1)
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1
Wright State Physicians
Fairborn, Ohio, United States, 45324