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

NCT03991936 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1609017586
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Keywords

Nail Psoriasis; Nail Diseases; Triamcinolone acetonide; Triamcinolone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)

  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)

  Baseline, 24 weeks (end of study)

• Number of Participants With at Least One Adverse Event

  24 weeks (end of study)

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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

Triamcinolone Acetonide 2.5 mg/mL

EXPERIMENTAL

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

Triamcinolone Acetonide 5.0 mg/mL

EXPERIMENTAL

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

Triamcinolone Acetonide 7.5 mg/mL

EXPERIMENTAL

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

Triamcinolone Acetonide 10 mg/mL

EXPERIMENTAL

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

Interventions

Placebos DRUG

Normal saline intralesional injection

Also known as: Saline solution for injection

Placebo

Triamcinolone Acetonide 2.5 mg/mL DRUG

2.5 mg/mL intralesional injection

Also known as: Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension

Triamcinolone Acetonide 2.5 mg/mL

Triamcinolone Acetonide 5.0 mg/mL DRUG

5.0 mg/mL intralesional injection

Also known as: Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension

Triamcinolone Acetonide 5.0 mg/mL

Triamcinolone Acetonide 7.5 mg/mL DRUG

7.5 mg/mL intralesional injection

Also known as: Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension

Triamcinolone Acetonide 7.5 mg/mL

Triamcinolone Acetonide 10 mg/mL DRUG

10 mg/mL intralesional injection

Also known as: Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension

Triamcinolone Acetonide 10 mg/mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Nail Diseases

Interventions

Saline Solution; Injections; Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Shari Lipner
• Organization: Weill Cornell Medicine

shl9032@med.cornell.edu

6469623376

Study Officials

• Shari Lipner, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 19, 2019
• Study Start: March 11, 2020
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)