Health TrialsbyHealthPanel

Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

ConditionsPlaque PsoriasisVitamin D3
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWright State University

About 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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Triamcinolone

    Drug

    Triamcinolone 0.1% daily

  • Vitamin D3

    Dietary supplement

    40,000 IU Vitamin D3 daily

  • Placebo

    Drug

    Placebo daily

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Triamcinolone Cream + Vitamin D3Experimental treatment 2 interventions
Group B: Triamcinolone Cream + PlaceboPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Improvement in Psoriasis Area and Severity Score (PASI) from baseline

Subjects achieving a 50% improvement from baseline (PASI 50)

Time frame
Week 28
2

Improvement in Investigator Grade Assessment (IGA) from baseline

Subjects achieving a 1 point reduction from baseline

Time frame
Week 28
3

Improvement in Body Surface Area (BSA) from baseline

Subjects achieving a 50% reduction from baseline

Time frame
Week 28

Secondary outcomes

1

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

Time frame
Week 28
2

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

Time frame
Week 28
3

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

Time frame
Week 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wright State University

Lead sponsor

Source ClinicalTrials.gov
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