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Corticosteroid

Triamcinolone + Vitamin D for Psoriasis

Phase < 1
Recruiting
Led By Jeffrey B Travers, MD, PhD
Research Sponsored by Wright State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Age 18 and older
Must not have
No calcium supplements 1 month prior to baseline (not including multivitamins)
History of parathyroid abnormalities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 28

Summary

This trial is testing whether a cream containing triamcinolone, a steroid, is more effective when used with vitamin D3 to treat psoriasis.

Who is the study for?
Adults with mild to severe plaque psoriasis can join this trial. They must not be on certain medications that affect blood ion balance, have taken calcium supplements recently, or have unstable illnesses. People with a history of kidney stones, parathyroid issues, osteoporosis, or who are using tanning beds cannot participate.
What is being tested?
The study tests if triamcinolone cream combined with high-dose vitamin D3 pills is more effective for psoriasis than the cream alone. Participants first use the cream for 4 weeks and then get either vitamin D3 or a placebo randomly for 12 weeks before all receive vitamin D3 for another 12 weeks.
What are the potential side effects?
Possible side effects include skin irritation from triamcinolone and high calcium levels due to vitamin D3 intake which could lead to kidney stones or digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have psoriasis covering 2% or more of my body.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken calcium supplements, except in multivitamins, for a month.
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I have had issues with my parathyroid glands.
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I have had kidney stones in the past.
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I regularly use a tanning bed or get a lot of sunlight.
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I do not have any uncontrolled serious illnesses.
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I am on medication that affects my blood's ion balance.
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I have had kidney problems in the past.
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I have been diagnosed with osteoporosis.
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I haven't taken any biologic medication for at least 8 weeks.
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I have a history of severe arthritis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement in Body Surface Area (BSA) from baseline
Improvement in Investigator Grade Assessment (IGA) from baseline
Improvement in Psoriasis Area and Severity Score (PASI) from baseline
Secondary study objectives
Change in 25-Hydroxyvitamin D Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3
Change in Complete Metabolic Profile Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3
Change in Parathyroid Hormone Level Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Triamcinolone Cream + Vitamin D3Experimental Treatment2 Interventions
This arm will continue to take Vitamin D3 at Week 16 to Week 28.
Group II: Triamcinolone Cream + PlaceboPlacebo Group3 Interventions
Starting at Week 16, this arm will be given Vitamin D3 to take until Week 28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D3
2011
Completed Phase 4
~3590
Triamcinolone
2016
Completed Phase 4
~1220

Find a Location

Who is running the clinical trial?

Wright State UniversityLead Sponsor
46 Previous Clinical Trials
55,284 Total Patients Enrolled
Wright State PhysiciansLead Sponsor
3 Previous Clinical Trials
72 Total Patients Enrolled
Jeffrey B Travers, MD, PhDPrincipal InvestigatorWright State University
9 Previous Clinical Trials
236 Total Patients Enrolled

Media Library

Triamcinolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04036188 — Phase < 1
Plaque Psoriasis Research Study Groups: Triamcinolone Cream + Placebo, Triamcinolone Cream + Vitamin D3
Plaque Psoriasis Clinical Trial 2023: Triamcinolone Highlights & Side Effects. Trial Name: NCT04036188 — Phase < 1
Triamcinolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04036188 — Phase < 1
~0 spots leftby Dec 2024
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