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

NCT ID: NCT03991936

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-11
• Study Completion Date: 2023-03-29

Brief Summary

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

Conditions

Nail Psoriasis; Nail Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Normal saline intralesional injection

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.

Group Type: EXPERIMENTAL

Triamcinolone Acetonide 2.5 mg/mL

Intervention Type: DRUG

2.5 mg/mL intralesional injection

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.

Group Type: EXPERIMENTAL

Triamcinolone Acetonide 5.0 mg/mL

Intervention Type: DRUG

5.0 mg/mL intralesional injection

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.

Group Type: EXPERIMENTAL

Triamcinolone Acetonide 7.5 mg/mL

Intervention Type: DRUG

7.5 mg/mL intralesional injection

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.

Group Type: EXPERIMENTAL

Triamcinolone Acetonide 10 mg/mL

Intervention Type: DRUG

10 mg/mL intralesional injection

Interventions

Placebos

Normal saline intralesional injection

Intervention Type: DRUG

Triamcinolone Acetonide 2.5 mg/mL

2.5 mg/mL intralesional injection

Intervention Type: DRUG

Triamcinolone Acetonide 5.0 mg/mL

5.0 mg/mL intralesional injection

Intervention Type: DRUG

Triamcinolone Acetonide 7.5 mg/mL

7.5 mg/mL intralesional injection

Intervention Type: DRUG

Triamcinolone Acetonide 10 mg/mL

10 mg/mL intralesional injection

Intervention Type: DRUG

Other Intervention Names

Saline solution for injection; Triamcinolone Injection; Kenalog 10 MG/ML Injectable Suspension; Triamcinolone Injection; Kenalog 10 MG/ML Injectable Suspension; Triamcinolone Injection; Kenalog 10 MG/ML Injectable Suspension; Triamcinolone Injection; Kenalog 10 MG/ML Injectable Suspension

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shari Lipner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Medical College of Cornell University

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1609017586

Identifier Type: -

Identifier Source: org_study_id