Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

NCT04036188 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 06715
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  Week 28

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

  Week 28

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

  Week 28

Study Arms (2)

Triamcinolone Cream + Vitamin D3

EXPERIMENTAL

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

Drug: Triamcinolone; Dietary Supplement: Vitamin D3

Triamcinolone Cream + Placebo

PLACEBO COMPARATOR

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

Drug: Triamcinolone; Dietary Supplement: Vitamin D3; Drug: Placebo

Interventions

Triamcinolone DRUG

Triamcinolone 0.1% daily

Triamcinolone Cream + Placebo; Triamcinolone Cream + Vitamin D3

Vitamin D3 DIETARY_SUPPLEMENT

40,000 IU Vitamin D3 daily

Triamcinolone Cream + Placebo; Triamcinolone Cream + Vitamin D3

Placebo DRUG

Placebo daily

Triamcinolone Cream + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Wright State Physicians

Fairborn, Ohio, 45324, United States

RECRUITING

MeSH Terms

Interventions

Triamcinolone; Cholecalciferol

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Cholestenes; Cholestanes; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Jeffrey B Travers, MD, PhD

  Wright State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manager, Clinical Research Operations

CONTACT

937-245-7500; pturesearch@wrightstatephysicians.org

Regulatory Specialist

CONTACT

937-245-7500; pturesearch@wrightstatephysicians.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects, investigators and blinded research staff will be masked until subjects start the open label part of the study.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: July 29, 2019
• Study Start: October 16, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)