Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

Study Overview
=================
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.

Official Title
-----------------
Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

Conditions
-----------------
Plaque Psoriasis, Vitamin D3

Intervention / Treatment
-----------------
* Drug: Triamcinolone
* Dietary Supplement: Vitamin D3
* Drug: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triamcinolone Cream + Vitamin D3<br>This arm will continue to take Vitamin D3 at Week 16 to Week 28. | Drug: Triamcinolone<br>* Triamcinolone 0.1% daily<br>Dietary Supplement: Vitamin D3<br>* 40,000 IU Vitamin D3 daily<br>|
| Placebo Comparator: Triamcinolone Cream + Placebo<br>Starting at Week 16, this arm will be given Vitamin D3 to take until Week 28. | Drug: Triamcinolone<br>* Triamcinolone 0.1% daily<br>Dietary Supplement: Vitamin D3<br>* 40,000 IU Vitamin D3 daily<br>Drug: Placebo<br>* Placebo daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Psoriasis Area and Severity Score (PASI) from baseline | Subjects achieving a 50% improvement from baseline (PASI 50) | Week 28 | 
| Improvement in Investigator Grade Assessment (IGA) from baseline | Subjects achieving a 1 point reduction from baseline | Week 28 | 
| Improvement in Body Surface Area (BSA) from baseline | Subjects achieving a 50% reduction from baseline | Week 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Complete Metabolic Profile Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 | Assess change through complete metabolic profile laboratory values | Week 28 | 
| Change in Parathyroid Hormone Level Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 | Assess change through parathyroid hormone level laboratory values | Week 28 | 
| Change in 25-Hydroxyvitamin D Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 | Assess change through 25-Hydroxyvitamin D laboratory values | Week 28 |