Recruiting
Early Phase 1

Triamcinolone with Vitamin D

Sponsor:

Wright State University

Code:

NCT04036188

Conditions

Plaque Psoriasis

Vitamin D3

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Triamcinolone

Vitamin D3

Placebo

Study Details

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.

Conditions

Plaque Psoriasis

Vitamin D3

Study ID

NCT04036188

Start date

Oct 16, 2019

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Triamcinolone Cream + Vitamin D3

This arm will continue to take Vitamin D3 at Week 16 to Week 28.

placebo comparator: Triamcinolone Cream + Placebo

Starting at Week 16, this arm will be given Vitamin D3 to take until Week 28.

Interventions

Triamcinolone

Triamcinolone 0.1% daily

Vitamin D3

40,000 IU Vitamin D3 daily

Placebo

Placebo daily

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Manager, Clinical Research Operations

937-245-7500pturesearch@wrightstatephysicians.org

Regulatory Specialist

937-245-7500pturesearch@wrightstatephysicians.org

Locations

Wright State Physicians

Recruiting

Fairborn, Ohio, United States, 45324

More Information

Sponsor

Wright State University

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wright State University on 2026-02-19.