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

Nail Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991936
• Other study ID #: 1609017586
• Status: Completed
• Phase: Phase 4
• Start date: March 11, 2020
• Est. completion date: March 29, 2023

Study information

• Verified date: February 2024
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nail Diseases
• Nail Psoriasis
• Psoriasis

Intervention

Drug:
• Placebos
Normal saline intralesional injection
• Triamcinolone Acetonide 2.5 mg/mL
2.5 mg/mL intralesional injection
• Triamcinolone Acetonide 5.0 mg/mL
5.0 mg/mL intralesional injection
• Triamcinolone Acetonide 7.5 mg/mL
7.5 mg/mL intralesional injection
• Triamcinolone Acetonide 10 mg/mL
10 mg/mL intralesional injection

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, 24 weeks (end of study)
Secondary	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 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.	Baseline, 24 weeks (end of study)
Secondary	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)