Plaque PsoriasisEarly Phase 1NCT04036188
Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis
A Early Phase 1 study testing Triamcinolone and Vitamin D3 in people with Plaque Psoriasis and Vitamin D3, run by Wright State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis, Vitamin D3
- What is being tested?
- Triamcinolone and Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2019to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wright State Physicians
Fairborn, Ohio, 45324
About this study
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.
- Conditions
- Plaque Psoriasis, Vitamin D3
- Being tested
- Triamcinolone, Vitamin D3, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
Triamcinolone 0.1% daily
Vitamin D3Dietary supplement
40,000 IU Vitamin D3 daily
PlaceboDrug
Placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone Cream + Vitamin D3 | Experimental | This arm will continue to take Vitamin D3 at Week 16 to Week 28. Receives: Drug: Triamcinolone; Dietary Supplement: Vitamin D3 |
| Triamcinolone Cream + Placebo | Placebo comparator | Starting at Week 16, this arm will be given Vitamin D3 to take until Week 28. Receives: Drug: Triamcinolone; Dietary Supplement: Vitamin D3; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Psoriasis Area and Severity Score (PASI) from baseline
Subjects achieving a 50% improvement from baseline (PASI 50)
Measured: Week 28
Improvement in Investigator Grade Assessment (IGA) from baseline
Subjects achieving a 1 point reduction from baseline
Measured: Week 28
Improvement in Body Surface Area (BSA) from baseline
Subjects achieving a 50% reduction from baseline
Measured: Week 28
Secondary outcomes (3)
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
Measured: Week 28
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
Measured: Week 28
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
Measured: Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start16 Oct 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey B Travers, MD, PhD, Principal investigator, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036188
- Sponsor's protocol ID
- 06715
- Status last verified
- Feb 2026
- First submitted
- 17 May 2019
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis
- ClinicalTrials.gov ID
- NCT04036188
- Acronym / sponsor ID
- 06715
- Conditions
- Plaque Psoriasis, Vitamin D3
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone Cream + Vitamin D3 | Experimental | Drug: Triamcinolone, Dietary Supplement: Vitamin D3This arm will continue to take Vitamin D3 at Week 16 to Week 28. |
| Triamcinolone Cream + Placebo | Placebo comparator | Drug: Triamcinolone, Dietary Supplement: Vitamin D3, Drug: PlaceboStarting at Week 16, this arm will be given Vitamin D3 to take until Week 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriamcinoloneTriamcinolone 0.1% daily | Drug | Triamcinolone Cream + Placebo, Triamcinolone Cream + Vitamin D3 |
| Vitamin D340,000 IU Vitamin D3 daily | Dietary supplement | Triamcinolone Cream + Placebo, Triamcinolone Cream + Vitamin D3 |
| PlaceboPlacebo daily | Drug | Triamcinolone Cream + Placebo |
Primary outcome
Improvement in Psoriasis Area and Severity Score (PASI) from baseline
Time frame: Week 28
Subjects achieving a 50% improvement from baseline (PASI 50)
Improvement in Investigator Grade Assessment (IGA) from baseline
Time frame: Week 28
Subjects achieving a 1 point reduction from baseline
Improvement in Body Surface Area (BSA) from baseline
Time frame: Week 28
Subjects achieving a 50% reduction from baseline
3 secondary outcomes
Change in Complete Metabolic Profile Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3
Time frame: Week 28
Change in Parathyroid Hormone Level Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3
Time frame: Week 28
Change in 25-Hydroxyvitamin D Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3
Time frame: Week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey B Travers, MD, PhD principal investigator
Wright State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Triamcinolone and Vitamin D3 in people with Plaque Psoriasis and Vitamin D3, run by Wright State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manager, Clinical Research Operations (937-245-7500, pturesearch@wrightstatephysicians.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Psoriasis Area and Severity Score (PASI) from baseline (time frame: Week 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.