Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04036188
• Other study ID #: 06715
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 16, 2019
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Wright State University
• Contact: Manager, Clinical Research Operations
• Phone: 937-245-7500
• Email: pturesearch[@]wrightstatephysicians.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis
• Vitamin D3

Intervention

Drug:
• Triamcinolone
Triamcinolone 0.1% daily

Dietary Supplement:
• Vitamin D3
40,000 IU Vitamin D3 daily

Drug:
• Placebo
Placebo daily

Locations

Country	Name	City	State
United States	Wright State Physicians	Fairborn	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Wright State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Psoriasis Area and Severity Score (PASI) from baseline	Subjects achieving a 50% improvement from baseline (PASI 50)	Week 28
Primary	Improvement in Investigator Grade Assessment (IGA) from baseline	Subjects achieving a 1 point reduction from baseline	Week 28
Primary	Improvement in Body Surface Area (BSA) from baseline	Subjects achieving a 50% reduction from baseline	Week 28
Secondary	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
Secondary	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	Week 28
Secondary	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