Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 4 weeks, 28 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "The study will take place over 28 weeks total."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This 28-week study tests whether triamcinolone skin cream works better for psoriasis when paired with 40,000 IU of vitamin D3 taken daily. It focuses on mild to moderate psoriasis, but the entry rules allow adults with mild to severe plaque psoriasis, which causes thick, scaly skin patches. Everyone uses the cream first, then gets vitamin D3 or a dummy pill, and later everyone gets vitamin D3.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older.
- Have mild to severe plaque psoriasis covering at least 2% of your body, with a psoriasis area and severity score of at least 2.
Who can't join
- Take medicine that changes the balance of minerals in your blood, or took calcium supplements in the month before starting. Multivitamins are allowed.
- Have an illness that is not stable or controlled, or blood or other test results that the study doctor thinks could affect safety or study results.
- Used certain non-biologic medicines that treat the whole body within 28 days before starting, or biologic medicines within 8 weeks or longer, depending on how long the drug stays in your body.
- Had light treatment, used tanning beds, or sunbathed to treat psoriasis within 28 days before starting; or still use tanning beds, other UV light devices, or get too much sunlight.
- Used certain skin treatments or medicated shampoos within 14 days before starting. Some lower-strength steroid creams are allowed on the face and in skin folds.
- Have a history of kidney problems, kidney stones, or problems with the parathyroid glands, which help control calcium levels.
- Have osteoporosis (weak bones) or a history of severe arthritis (joint disease).
- Cannot understand or complete the consent process to agree to join the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
OH
- Wright State Physicians · Fairborn, OH 45324More trials in Fairborn