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

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ClinicalTrials.gov Identifier: NCT03991936
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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

Condition or disease Intervention/treatment Phase
Nail Psoriasis Nail Diseases Drug: Placebos Drug: Triamcinolone Acetonide 2.5 mg/mL Drug: Triamcinolone Acetonide 5.0 mg/mL Drug: Triamcinolone Acetonide 7.5 mg/mL Drug: Triamcinolone Acetonide 10 mg/mL Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants receive an intralesional injection of 0.1-0.2 mL of normal saline in one psoriatic fingernail once per 6 weeks until 24 weeks.
Drug: Placebos
Normal saline intralesional injection
Other Name: Saline solution for injection

Experimental: Triamcinolone Acetonide 2.5 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Drug: Triamcinolone Acetonide 2.5 mg/mL
2.5 mg/mL intralesional injection
Other Names:
  • Triamcinolone Injection
  • Kenalog 10 MG/ML Injectable Suspension

Experimental: Triamcinolone Acetonide 5.0 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 5.0 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Drug: Triamcinolone Acetonide 5.0 mg/mL
5.0 mg/mL intralesional injection
Other Names:
  • Triamcinolone Injection
  • Kenalog 10 MG/ML Injectable Suspension

Experimental: Triamcinolone Acetonide 7.5 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 7.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Drug: Triamcinolone Acetonide 7.5 mg/mL
7.5 mg/mL intralesional injection
Other Names:
  • Triamcinolone Injection
  • Kenalog 10 MG/ML Injectable Suspension

Experimental: Triamcinolone Acetonide 10 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Drug: Triamcinolone Acetonide 10 mg/mL
10 mg/mL intralesional injection
Other Names:
  • Triamcinolone Injection
  • Kenalog 10 MG/ML Injectable Suspension




Primary Outcome Measures :
  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 Outcome Measures :
  1. Change from baseline in nail psoriasis, as measured by Nail Psoriasis Severity Index (NAPSI) [ Time Frame: 6 weeks, 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 consists of 10 questions that assess the effects of nail psoriasis on daily activities. Each response is given a score of 0 to 2 and, as some questions are specific to toes or fingernails, final scores are converted to percentages based on the number of questions the patient has been able to answer. The value of the score obtained is proportional to the functional difficulty experienced.

  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.



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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:

  • 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

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): NCT03991936


Contacts
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Contact: Krysta Lin, BS ‪657-549-5546‬ krl4001@med.cornell.edu

Locations
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United States, New York
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10021
Contact: Shari Lipner, MD, PhD    646-962-3376    shl9032@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Shari Lipner, MD, PhD Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03991936     History of Changes
Other Study ID Numbers: 1609017586
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Weill Medical College of Cornell University:
Nail Psoriasis
Nail Diseases
Triamcinolone acetonide
Triamcinolone

Additional relevant MeSH terms:
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Psoriasis
Nail Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action