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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

Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE July 29, 2019
Last Update Posted Date September 13, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04036188 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2019)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis
Official Title  ICMJE Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Plaque Psoriasis
  • Vitamin D3
Intervention  ICMJE
  • Drug: Triamcinolone
    Triamcinolone 0.1% daily
  • Dietary Supplement: Vitamin D3
    40,000 IU Vitamin D3 daily
  • Drug: Placebo
    Placebo daily
Study Arms  ICMJE
  • Experimental: Triamcinolone Cream + Vitamin D3
    This arm will continue to take Vitamin D3 at Week 16 to Week 28.
    Interventions:
    • Drug: Triamcinolone
    • Dietary Supplement: Vitamin D3
  • Placebo Comparator: Triamcinolone Cream + Placebo
    Starting at Week 16, this arm will be given Vitamin D3 to take until Week 28.
    Interventions:
    • Drug: Triamcinolone
    • Dietary Supplement: Vitamin D3
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Manager, Clinical Research Operations 937-245-7500 pturesearch@wrightstatephysicians.org
Contact: Regulatory Specialist 937-245-7500 pturesearch@wrightstatephysicians.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04036188
Other Study ID Numbers  ICMJE 06715
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey B. Travers, MD, PhD, Wright State Physicians
Study Sponsor  ICMJE Wright State Physicians
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey B Travers, MD, PhD Wright State Physicians
PRS Account Wright State Physicians
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP