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

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

Study Overview

• Status: Completed
• Conditions: Nail Diseases; Nail Psoriasis
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Medical College of Cornell University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

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.	Baseline, 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 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)
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)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Shari Lipner, MD, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2020
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Triamcinolone; Nail Diseases; Nail Psoriasis; Triamcinolone acetonide
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Nail Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 1609017586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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