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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 28
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have psoriasis covering 2% or more of my body.
Select...
I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
41 Previous Clinical Trials
54,858 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what health conditions is Vitamin D3 administered?

"Vitamin D3 can effectively manage ulcerative colitis, hand ailments, and even brain issues."

Answered by AI

Could you elucidate on any other studies involving Vitamin D3?

"Currently, there are 41 trials for Vitamin D3 in progress with 8 reaching Phase 3. These studies span 75 different sites across Columbia, Missouri and beyond."

Answered by AI

How many persons are enrolled in this clinical trial?

"Correct. According to information hosted on clinicaltrials.gov, this medical investigation is currently seeking patients for enrollment; the trial was initially posted on October 16th 2019 and last modified 9/7/2022. 24 individuals need to be recruited from a single location."

Answered by AI

Are there opportunities for participants to join this experiment?

"Yes, the clinicaltrials.gov platform notes that this medical research is currently looking for participants to join their program. The study was published on October 16th 2019 and updated most recently on September 7th 2022, with a total of 24 patients needed from one site."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Wright State Physicians
What portion of applicants met pre-screening criteria?
Met criteria
~3 spots leftby Dec 2024