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Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

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ClinicalTrials.gov Identifier: NCT04036188
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey B. Travers, MD, PhD, Wright State Physicians

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Vitamin D3 Drug: Triamcinolone Dietary Supplement: Vitamin D3 Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description: Subjects, investigators and blinded research staff will be masked until subjects start the open label part of the study.
Primary Purpose: Treatment
Official Title: Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2022


Arm Intervention/treatment
Experimental: Triamcinolone Cream + Vitamin D3
This arm will continue to take Vitamin D3 at Week 16 to Week 28.
Drug: Triamcinolone
Triamcinolone 0.1% daily

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

Placebo Comparator: Triamcinolone Cream + Placebo
Starting at Week 16, this arm will be given Vitamin D3 to take until Week 28.
Drug: Triamcinolone
Triamcinolone 0.1% daily

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

Drug: Placebo
Placebo daily




Primary Outcome Measures :
  1. Improvement in Psoriasis Area and Severity Score (PASI) from baseline [ Time Frame: Week 28 ]
    Subjects achieving a 50% improvement from baseline (PASI 50)

  2. Improvement in Investigator Grade Assessment (IGA) from baseline [ Time Frame: Week 28 ]
    Subjects achieving a 1 point reduction from baseline

  3. Improvement in Body Surface Area (BSA) from baseline [ Time Frame: Week 28 ]
    Subjects achieving a 50% reduction from baseline


Secondary Outcome Measures :
  1. Change in Complete Metabolic Profile Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 [ Time Frame: Week 28 ]
    Assess change through complete metabolic profile laboratory values

  2. Change in Parathyroid Hormone Level Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 [ Time Frame: Week 28 ]
    Assess change through parathyroid hormone level laboratory values

  3. Change in 25-Hydroxyvitamin D Values From Baseline Due to the Combination of Topical Triamcinolone Cream and Oral Vitamin D3 [ Time Frame: Week 28 ]
    Assess change through 25-Hydroxyvitamin D laboratory values



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 [PUVA] light therapy; cyclosporine; corticosteroids; methotrexate; oral retinoids; apremilast; tofacitinib; mycophenolate mofetil; thioguanine; hydroxyurea; sirolimus; tacrolimus; azathioprine; lefludimide; 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036188


Contacts
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Contact: Manager, Clinical Research Operations 937-245-7500 pturesearch@wrightstatephysicians.org
Contact: Regulatory Specialist 937-245-7500 pturesearch@wrightstatephysicians.org

Locations
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United States, Ohio
Wright State Physicians Not yet recruiting
Fairborn, Ohio, United States, 45324
Sponsors and Collaborators
Wright State Physicians
Investigators
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Principal Investigator: Jeffrey B Travers, MD, PhD Wright State Physicians

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Responsible Party: Jeffrey B. Travers, MD, PhD, Chair, Department of Pharmacology and Toxicology for Boonshoft School of Medicine, Wright State Physicians, Wright State Physicians
ClinicalTrials.gov Identifier: NCT04036188     History of Changes
Other Study ID Numbers: 06715
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action