Triamcinolone + Vitamin D for Psoriasis

Palo Alto (17 mi)

Overseen byJeffrey B Travers, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Wright State University

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I have psoriasis covering 2% or more of my body.

I am 18 years old or older.

Exclusion Criteria

I haven't taken calcium supplements, except in multivitamins, for a month.

I have had issues with my parathyroid glands.

I have had kidney stones in the past.

I regularly use a tanning bed or get a lot of sunlight.

I do not have any uncontrolled serious illnesses.

I am on medication that affects my blood's ion balance.

I have had kidney problems in the past.

I have been diagnosed with osteoporosis.

I haven't taken any biologic medication for at least 8 weeks.

I have a history of severe arthritis.

Treatment Details

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.

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.

Triamcinolone is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Kenalog for: