Plaque Psoriasis, Vitamin D3
Conditions
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.
Interventions
DRUGTriamcinolone
Triamcinolone 0.1% daily
DIETARY_SUPPLEMENTVitamin D3
40,000 IU Vitamin D3 daily
DRUGPlacebo
Placebo daily
Sponsors
Wright State University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Subjects, investigators and blinded research staff will be masked until subjects start the open label part of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Psoriasis Area and Severity Score (PASI) from baseline | Week 28 | Subjects achieving a 50% improvement from baseline (PASI 50) |
| Improvement in Investigator Grade Assessment (IGA) from baseline | Week 28 | Subjects achieving a 1 point reduction from baseline |
| Improvement in Body Surface Area (BSA) from baseline | Week 28 | Subjects achieving a 50% reduction from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Complete Metabolic Profile Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 | Week 28 | Assess change through complete metabolic profile laboratory values |
| Change in Parathyroid Hormone Level Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 | Week 28 | Assess change through parathyroid hormone level laboratory values |
| Change in 25-Hydroxyvitamin D Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 | Week 28 | Assess change through 25-Hydroxyvitamin D laboratory values |
Countries
United States
Contacts
CONTACTManager, Clinical Research Operations
CONTACTRegulatory Specialist
PRINCIPAL_INVESTIGATORJeffrey B Travers, MD, PhD
Wright State University
Outcome results
None listed