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

Primary Purpose

Nail Psoriasis, Nail Diseases

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Placebos

Triamcinolone Acetonide 2.5 mg/mL

Triamcinolone Acetonide 5.0 mg/mL

Triamcinolone Acetonide 7.5 mg/mL

Triamcinolone Acetonide 10 mg/mL

About this trial

This is an interventional treatment trial for Nail Psoriasis focused on measuring Nail Psoriasis, Nail Diseases, Triamcinolone acetonide, Triamcinolone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Weill Medical College of Cornell University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Triamcinolone Acetonide 2.5 mg/mL

Triamcinolone Acetonide 5.0 mg/mL

Triamcinolone Acetonide 7.5 mg/mL

Triamcinolone Acetonide 10 mg/mL

Arm 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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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 consists of 10 questions that assess the effects of nail psoriasis on daily activities. Each response is given a score of 0 to 2 and, as some questions are specific to toes or fingernails, final scores are converted to percentages based on the number of questions the patient has been able to answer. The value of the score obtained is proportional to the functional difficulty experienced.

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.

Full Information

NCT ID

NCT03991936

First Posted

June 18, 2019

Last Updated

April 18, 2023

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT03991936

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

March 11, 2020 (Actual)

Primary Completion Date

March 29, 2023 (Actual)

Study Completion Date

March 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nail Psoriasis, Nail Diseases

Keywords

Nail Psoriasis, Nail Diseases, Triamcinolone acetonide, Triamcinolone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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.

Arm Title

Triamcinolone Acetonide 2.5 mg/mL

Arm Type

Experimental

Arm 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.

Arm Title

Triamcinolone Acetonide 5.0 mg/mL

Arm Type

Experimental

Arm 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.

Arm Title

Triamcinolone Acetonide 7.5 mg/mL

Arm Type

Experimental

Arm 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.

Arm Title

Triamcinolone Acetonide 10 mg/mL

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Placebos

Other Intervention Name(s)

Saline solution for injection

Intervention Description

Normal saline intralesional injection

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide 2.5 mg/mL

Other Intervention Name(s)

Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension

Intervention Description

2.5 mg/mL intralesional injection

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide 5.0 mg/mL

Other Intervention Name(s)

Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension

Intervention Description

5.0 mg/mL intralesional injection

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide 7.5 mg/mL

Other Intervention Name(s)

Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension

Intervention Description

7.5 mg/mL intralesional injection

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide 10 mg/mL

Other Intervention Name(s)

Triamcinolone Injection, Kenalog 10 MG/ML Injectable Suspension

Intervention Description

10 mg/mL intralesional injection

Primary Outcome Measure Information:

Title

Lowest effective concentration of intralesional triamcinolone acetonide for nail psoriasis

Description

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.

Time Frame

24 weeks (end of study)

Secondary Outcome Measure Information:

Title

Change from baseline in nail psoriasis, as measured by Nail Psoriasis Severity Index (NAPSI)

Description

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.

Time Frame

6 weeks, 24 weeks (end of study)

Title

Change from baseline in nail psoriasis qualify of life, as measured by Development and Validation of Nail Psoriasis Quality of Life Scale (NPQ10)

Description

Time Frame

Baseline, 24 weeks (end of study)

Title

Number of participants with at least one adverse event

Description

Adverse events will only include those that are determined to be related to the study drug.

Time Frame

24 weeks (end of study)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shari Lipner, MD, PhD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Medical College of Cornell University

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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