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.

Study Overview

• Status: Recruiting
• Conditions: Plaque Psoriasis; Vitamin D3
• Intervention / Treatment: Drug: Placebo; Drug: Triamcinolone; Dietary supplement: Vitamin D3

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Manager, Clinical Research Operations; Phone Number: 937-245-7500; Email: pturesearch@wrightstatephysicians.org
• Study Contact Backup: Name: Regulatory Specialist; Phone Number: 937-245-7500; Email: pturesearch@wrightstatephysicians.org

Study Locations

• United States
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Recruiting
      • Wright State Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triamcinolone Cream + Vitamin D3; This arm will continue to take Vitamin D3 at Week 16 to Week 28.	Drug: Triamcinolone; Triamcinolone 0.1% daily; Dietary supplement: Vitamin D3; 40,000 IU Vitamin D3 daily
Placebo Comparator: Triamcinolone Cream + Placebo; Starting at Week 16, this arm will be given Vitamin D3 to take until Week 28.	Drug: Placebo; Placebo daily; Drug: Triamcinolone; Triamcinolone 0.1% daily; Dietary supplement: Vitamin D3; 40,000 IU Vitamin D3 daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Complete Metabolic Profile Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3	Assess change through complete metabolic profile laboratory values	Week 28
Change in Parathyroid Hormone Level Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3	Assess change through parathyroid hormone level laboratory values	Week 28
Change in 25-Hydroxyvitamin D Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3	Assess change through 25-Hydroxyvitamin D laboratory values	Week 28

Collaborators and Investigators

• Sponsor: Wright State University
• Investigators: Principal Investigator: Jeffrey B Travers, MD, PhD, Wright State University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Lipids; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Cholestenes; Cholestanes; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Triamcinolone; Cholecalciferol
• Other Study ID Numbers: 06715

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes