Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

Last updated: January 24, 2025
Sponsor: Wright State University
Overall Status: Active - Recruiting

Phase

1

Condition

Warts

Scalp Disorders

Psoriasis And Psoriatic Disorders

Treatment

Vitamin D3

Placebo

Triamcinolone

Clinical Study ID

NCT04036188
06715
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Age 18 and older

  • Mild to severe plaque psoriasis (2% or greater Body Surface Area; Psoriasis Area andSeverity Score of 2 or greater; Investigator Grade Assessment of mild-severe)

Exclusion

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 tocerebro-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 psoralenplus 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 D3and analogues) within 28 days prior to baseline.

  • No phototherapy (including either oral and topical PUVA light therapy, ultravioletB, 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 midstrength or lower potency topical steroids are permitted on the intertriginous areasand face], crisaborole, anthralin, calcipotriene, topical vitamin D derivatives,retinoids, tazarotene, pimecrolimus, tacrolimus, emollients and othernonprescription topical products containing urea, >3% salicylic acid, alpha- orbeta-hydroxyl acids, or medicated shampoos [for example those that contain >3%salicylic acid, corticosteroids, coal tar, or vitamin D3 analogues]) within 14 daysprior to baseline.

  • No biologic agents within 8 weeks or three half-lives, whichever is greater prior tobaseline.

  • 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.

Study Design

Total Participants: 24
Treatment Group(s): 3
Primary Treatment: Vitamin D3
Phase: 1
Study Start date:
October 16, 2019
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Wright State Physicians

    Fairborn, Ohio 45324
    United States

    Active - Recruiting

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