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NCT Number: NCT04036188

Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triamcinolone

Drug

Triamcinolone 0.1% daily

Vitamin D3

Dietary Supplement

40,000 IU Vitamin D3 daily

Placebo

Drug

Placebo daily

Primary outcomes

  1. Improvement in Psoriasis Area and Severity Score (PASI) from baseline

    Time frame: Week 28

    Subjects achieving a 50% improvement from baseline (PASI 50)

  2. Improvement in Investigator Grade Assessment (IGA) from baseline

    Time frame: Week 28

    Subjects achieving a 1 point reduction from baseline

  3. Improvement in Body Surface Area (BSA) from baseline

    Time frame: Week 28

    Subjects achieving a 50% reduction from baseline

Secondary outcomes

  1. Change in Complete Metabolic Profile Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3

    Time frame: Week 28

    Assess change through complete metabolic profile laboratory values

  2. Change in Parathyroid Hormone Level Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3

    Time frame: Week 28

    Assess change through parathyroid hormone level laboratory values

  3. Change in 25-Hydroxyvitamin D Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3

    Time frame: Week 28

    Assess change through 25-Hydroxyvitamin D laboratory values

Study contacts

Contact information is provided by the study sponsor or research team.

Manager, Clinical Research Operations

CONTACT

[email protected]

937-245-7500

Regulatory Specialist

CONTACT

[email protected]

937-245-7500

Sponsors and collaborators

Lead sponsor

Wright State University

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2019
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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