Clinical trial NCT04036188: Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis
Official title: Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Plaque Psoriasis
Vitamin D3
Lead sponsor: Wright State University
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Improvement in Psoriasis Area and Severity Score (PASI) from baseline
timeFrame: Week 28
measure: Improvement in Investigator Grade Assessment (IGA) from baseline
timeFrame: Week 28
measure: Improvement in Body Surface Area (BSA) from baseline
timeFrame: Week 28
Secondary outcomes:
measure: Change in Complete Metabolic Profile Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3
timeFrame: Week 28
measure: Change in Parathyroid Hormone Level Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3
timeFrame: Week 28
measure: Change in 25-Hydroxyvitamin D Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3
timeFrame: Week 28
Other outcomes:
Locations:
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
Study officials:
affiliation: Wright State University
name: Jeffrey B Travers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: