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Recruiting NCT04036188

Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

Early Phase I Interventional Plaque Psoriasis Vitamin D3

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Triamcinolone, Vitamin D3, Placebo.
Who it may be relevant to
Registry conditions: Plaque Psoriasis, Vitamin D3. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug Triamcinolone
    Triamcinolone 0.1% daily
  • Dietary supplement Vitamin D3
    40,000 IU Vitamin D3 daily
  • Drug Placebo
    Placebo daily

Primary outcome measures

  • Improvement in Psoriasis Area and Severity Score (PASI) from baseline [Time frame: Week 28]
  • Improvement in Investigator Grade Assessment (IGA) from baseline [Time frame: Week 28]
  • Improvement in Body Surface Area (BSA) from baseline [Time frame: Week 28]
Secondary outcome measures (3)
  • Change in Complete Metabolic Profile Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 [Time frame: Week 28]
  • Change in Parathyroid Hormone Level Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 [Time frame: Week 28]
  • Change in 25-Hydroxyvitamin D Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 [Time frame: Week 28]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wright State Physicians — Fairborn

Identifiers

NCT: NCT04036188 · 06715

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗