Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcinolone Cream + Vitamin D3 | Experimental | This arm will continue to take Vitamin D3 at Week 16 to Week 28. |
|
| Triamcinolone Cream + Placebo | Placebo Comparator | Starting at Week 16, this arm will be given Vitamin D3 to take until Week 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone | Drug | Triamcinolone 0.1% daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Psoriasis Area and Severity Score (PASI) from baseline | Subjects achieving a 50% improvement from baseline (PASI 50) | Week 28 |
| Improvement in Investigator Grade Assessment (IGA) from baseline | Subjects achieving a 1 point reduction from baseline | Week 28 |
| Improvement in Body Surface Area (BSA) from baseline | Subjects achieving a 50% reduction from baseline | Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 28 |
| Change in Parathyroid Hormone Level Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manager, Clinical Research Operations | Contact | 937-245-7500 | pturesearch@wrightstatephysicians.org | |
| Regulatory Specialist | Contact | 937-245-7500 | pturesearch@wrightstatephysicians.org |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey B Travers, MD, PhD | Wright State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wright State Physicians | Recruiting | Fairborn | Ohio | 45324 | United States |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 16, 2022 | Feb 20, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects, investigators and blinded research staff will be masked until subjects start the open label part of the study.
| Vitamin D3 | Dietary Supplement | 40,000 IU Vitamin D3 daily |
|
| Placebo | Drug | Placebo daily |
|
Assess change through parathyroid hormone level laboratory values |
| 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 | Week 28 |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |