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

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 4

Conditions: Nail Diseases; Nail Psoriasis

Treatments: Drug: Triamcinolone Acetonide 5.0 mg/mL; Drug: Triamcinolone Acetonide 10 mg/mL; Drug: Triamcinolone Acetonide 2.5 mg/mL; Drug: Placebos; Drug: Triamcinolone Acetonide 7.5 mg/mL

Study type: Interventional

Funder types: Other

Identifiers

NCT03991936

1609017586

Details and patient eligibility

About

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

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos

Triamcinolone Acetonide 2.5 mg/mL

Experimental group

Description:

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.

Treatment:

Drug: Triamcinolone Acetonide 2.5 mg/mL

Triamcinolone Acetonide 5.0 mg/mL

Experimental group

Description:

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.

Treatment:

Drug: Triamcinolone Acetonide 5.0 mg/mL

Triamcinolone Acetonide 7.5 mg/mL

Experimental group

Description:

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.

Treatment:

Drug: Triamcinolone Acetonide 7.5 mg/mL

Triamcinolone Acetonide 10 mg/mL

Experimental group

Description:

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.

Treatment:

Drug: Triamcinolone Acetonide 10 mg/mL