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Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

Primary Purpose

Plaque Psoriasis, Vitamin D3

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Triamcinolone

Vitamin D3

Placebo

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wright State PhysiciansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Triamcinolone Cream + Vitamin D3

Triamcinolone Cream + Placebo

Arm Description

This arm will continue to take Vitamin D3 at Week 16 to Week 28.

Starting at Week 16, this arm will be given Vitamin D3 to take until Week 28.

Outcomes

Primary Outcome Measures

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

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

Improvement in Investigator Grade Assessment (IGA) from baseline

Subjects achieving a 1 point reduction from baseline

Improvement in Body Surface Area (BSA) from baseline

Subjects achieving a 50% reduction from baseline

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT04036188

First Posted

May 17, 2019

Last Updated

February 22, 2023

Sponsor

Wright State University

1. Study Identification

Unique Protocol Identification Number

NCT04036188

Brief Title

Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

Official Title

Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 16, 2019 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wright State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis, Vitamin D3

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Masking Description

Subjects, investigators and blinded research staff will be masked until subjects start the open label part of the study.

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Triamcinolone Cream + Vitamin D3

Arm Type

Experimental

Arm Description

This arm will continue to take Vitamin D3 at Week 16 to Week 28.

Arm Title

Triamcinolone Cream + Placebo

Arm Type

Placebo Comparator

Arm Description

Starting at Week 16, this arm will be given Vitamin D3 to take until Week 28.

Intervention Type

Drug

Intervention Name(s)

Triamcinolone

Intervention Description

Triamcinolone 0.1% daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Intervention Description

40,000 IU Vitamin D3 daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo daily

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Week 28

Title

Improvement in Investigator Grade Assessment (IGA) from baseline

Description

Subjects achieving a 1 point reduction from baseline

Time Frame

Week 28

Title

Improvement in Body Surface Area (BSA) from baseline

Description

Subjects achieving a 50% reduction from baseline

Time Frame

Week 28

Secondary Outcome Measure Information:

Title

Change in Complete Metabolic Profile Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3

Description

Assess change through complete metabolic profile laboratory values

Time Frame

Week 28

Title

Change in Parathyroid Hormone Level Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3

Description

Assess change through parathyroid hormone level laboratory values

Time Frame

Week 28

Title

Change in 25-Hydroxyvitamin D Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3

Description

Assess change through 25-Hydroxyvitamin D laboratory values

Time Frame

Week 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Manager, Clinical Research Operations

Phone

937-245-7500

pturesearch@wrightstatephysicians.org

First Name & Middle Initial & Last Name or Official Title & Degree

Regulatory Specialist

Phone

937-245-7500

pturesearch@wrightstatephysicians.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey B Travers, MD, PhD

Organizational Affiliation

Wright State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wright State Physicians

City

Fairborn

State/Province

Ohio

ZIP/Postal Code

45324

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

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Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

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