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

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

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

Conditions
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Nail Psoriasis, Nail Diseases

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* Normal saline intralesional injection<br>* Other names: Saline solution for injection;|
| Experimental: Triamcinolone Acetonide 2.5 mg/mL<br>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<br>* 2.5 mg/mL intralesional injection<br>* Other names: Kenalog 10 MG/ML Injectable Suspension;|
| Experimental: Triamcinolone Acetonide 5.0 mg/mL<br>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<br>* 5.0 mg/mL intralesional injection<br>* Other names: Kenalog 10 MG/ML Injectable Suspension;|
| Experimental: Triamcinolone Acetonide 7.5 mg/mL<br>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<br>* 7.5 mg/mL intralesional injection<br>* Other names: Kenalog 10 MG/ML Injectable Suspension;|
| Experimental: Triamcinolone Acetonide 10 mg/mL<br>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<br>* 10 mg/mL intralesional injection<br>* Other names: Kenalog 10 MG/ML Injectable Suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowest effective concentration of intralesional triamcinolone acetonide for nail psoriasis | 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. | 24 weeks (end of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in nail psoriasis, as measured by Nail Psoriasis Severity Index (NAPSI) | 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. | 6 weeks, 24 weeks (end of study) | 
| Change from baseline in nail psoriasis qualify of life, as measured by Development and Validation of Nail Psoriasis Quality of Life Scale (NPQ10) | 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. | Baseline, 24 weeks (end of study) | 
| Number of participants with at least one adverse event | Adverse events will only include those that are determined to be related to the study drug. | 24 weeks (end of study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nail Psoriasis, Nail Diseases, Triamcinolone acetonide, Triamcinolone