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Completed

NCT Number: NCT03991936

Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis

This purpose of this study is to determine the lowest effective concentration of intralesional triamcinolone acetonide in the treatment of nail psoriasis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weill Medical College of Cornell University

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age
  • Diagnosed with nail psoriasis in at least 2 fingernails
  • Willing to give written informed consent and able to adhere to procedures and visit schedules
  • Must consent to having the fingernails photographed during the study period

Exclusion criteria

  • Subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with study evaluations or optimal participation in the study. This is including, but not limited to: immunodeficiency, onychomycosis, any other nail condition other than psoriasis, allergy to triamcinolone acetonide, local anesthetic, normal saline, or any other material used for procedures
  • Subject who has received radiation therapy, chemotherapy, and/or immunosuppressive drugs within 6 months of study, and/or oral corticosteroids for >1 month within the 6 months of study (exception: inhaled steroids)
  • Subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study
  • Subject who is unwilling to abstain from any cosmetic nail treatments outside those provided by the study clinic, beyond basic nail trimming (i.e. no spa nail treatments, no nail polish use, no other topical prescription nail medication)
  • Subject who is unwilling to abstain from any medical nail treatments on their nails other than the study intervention (i.e. topical steroids, anti-fungal creams) for the duration of the study intervention and for duration of the washout period (if applicable)
  • Subject who is part of the staff personnel directly involved with this study or a family member of the investigational study staff

Treatment and study plan

Placebos

Drug

Normal saline intralesional injection

Other names: Saline solution for injection

Triamcinolone Acetonide 2.5 mg/mL

Drug

2.5 mg/mL intralesional injection

Other names: Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension

Triamcinolone Acetonide 5.0 mg/mL

Drug

5.0 mg/mL intralesional injection

Other names: Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension

Triamcinolone Acetonide 7.5 mg/mL

Drug

7.5 mg/mL intralesional injection

Other names: Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension

Triamcinolone Acetonide 10 mg/mL

Drug

10 mg/mL intralesional injection

Other names: Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension

Primary outcomes

  1. Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis

    Time frame: 24 weeks (end of study)

    The most effective concentration of intralesional triamcinolone acetonide will be determined between 0 mg/mL, 2.5 mg/mL, 5.0 mg/mL, 7.5 mg/mL, and 10.0 mg/mL.

Secondary outcomes

  1. Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)

    Time frame: Baseline, 24 weeks (end of study)

    The Nail Psoriasis Severity Index (NAPSI) is used to evaluate nail psoriasis. Scores range from 0 to 8 with 0 indicating no nail psoriasis and higher scores indicating worsening nail psoriasis.

  2. Change From Baseline in Nail Psoriasis Qualify of Life, as Measured by Development and Validation of Nail Psoriasis Quality of Life Scale (NPQ10)

    Time frame: Baseline, 24 weeks (end of study)

    The NPQ10 comprises 10 questions gauging the impact of nail psoriasis on daily activities. Each response is scored from 0 to 2, resulting in a total score between 0 and 20, where higher values indicate a more significant impact. The final scores are converted to percentages, reflecting the proportion of questions answered by the patient. The obtained score correlates proportionally with the level of functional difficulty experienced, with 0% indicating no impairment and 100% indicating the worst possible impairment.

  3. Number of Participants With at Least One Adverse Event

    Time frame: 24 weeks (end of study)

    Adverse events will only include those that are determined to be related to the study drug.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 19, 2019
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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