Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

NCT ID: NCT04036188

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-16
• Study Completion Date: 2026-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Triamcinolone Cream + Vitamin D3

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

Group Type: EXPERIMENTAL

Triamcinolone

Intervention Type: DRUG

Triamcinolone 0.1% daily

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

40,000 IU Vitamin D3 daily

Triamcinolone Cream + Placebo

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

Group Type: PLACEBO_COMPARATOR

Triamcinolone

Intervention Type: DRUG

Triamcinolone 0.1% daily

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

40,000 IU Vitamin D3 daily

Placebo

Intervention Type: DRUG

Placebo daily

Interventions

Triamcinolone

Triamcinolone 0.1% daily

Intervention Type: DRUG

Vitamin D3

40,000 IU Vitamin D3 daily

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wright State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey B Travers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wright State University

Locations

Wright State Physicians

Fairborn, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Manager, Clinical Research Operations

Role: CONTACT

pturesearch@wrightstatephysicians.org

937-245-7500

Regulatory Specialist

Role: CONTACT

pturesearch@wrightstatephysicians.org

937-245-7500

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

06715

Identifier Type: -

Identifier Source: org_study_id