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This purpose of this study is to determine the lowest effective concentration of intralesional triamcinolone acetonide in the treatment of nail psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebos | Drug | Normal saline intralesional injection |
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| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shari Lipner, MD, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
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A total of 11 participants passed screening and were randomized.
Participants were recruited from one location in the United States
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Placebos: Normal saline intralesional injection |
| FG001 | Triamcinolone Acetonide 2.5 mg/mL |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2018 |
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| Triamcinolone Acetonide 2.5 mg/mL | Drug | 2.5 mg/mL intralesional injection |
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| Triamcinolone Acetonide 5.0 mg/mL | Drug | 5.0 mg/mL intralesional injection |
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| Triamcinolone Acetonide 7.5 mg/mL | Drug | 7.5 mg/mL intralesional injection |
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| Triamcinolone Acetonide 10 mg/mL | Drug | 10 mg/mL intralesional injection |
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| 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) |
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. Triamcinolone Acetonide 2.5 mg/mL: 2.5 mg/mL intralesional injection |
| FG002 | 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. Triamcinolone Acetonide 5.0 mg/mL: 5.0 mg/mL intralesional injection |
| FG003 | 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. Triamcinolone Acetonide 7.5 mg/mL: 7.5 mg/mL intralesional injection |
| FG004 | 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. Triamcinolone Acetonide 10 mg/mL: 10 mg/mL intralesional injection |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL, 5 mg/mL, 7.5 mg/mL or 10 mg/mL intralesional triamcinolone acetonide, or normal saline in one psoriatic fingernail once per 6 weeks until 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Fingernails |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
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| Nail Psoriasis Qualify of Life, as Measured by Development and Validation of Nail Psoriasis Quality | 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. | Mean | Full Range | percentage of NPQ10 score | Participants |
| |||||||||||||||||||
| 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 | The Nail Psoriasis Severity Index (NAPSI) measure is provided for units, and the number of fingernails included in each arm varies. Data is presented per arm, and an additional "Total" row is added. | Mean | Full Range | score on a scale | Fingernails |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol defined as participants completing 24-week follow-up visit | Posted | Number | mg/mL | 24 weeks (end of study) | Fingernails | Fingernails |
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| 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. | Per protocol population, defined as participants completing 24-week follow-up visit | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 24 weeks (end of study) | Fingernails | Fingernails |
| |||||||||||||||||||||||||||
| 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. | Per protocol population, defined as participants completing the 24-week follow-up visit. | Posted | Mean | Full Range | percentage of NPQ10 score | Baseline, 24 weeks (end of study) |
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| 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. | Posted | Count of Participants | Participants | 24 weeks (end of study) |
|
24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Placebos: Normal saline intralesional injection | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | 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. Triamcinolone Acetonide 2.5 mg/mL: 2.5 mg/mL intralesional injection | 0 | 10 | 0 | 10 | 4 | 10 |
| EG002 | 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. Triamcinolone Acetonide 5.0 mg/mL: 5.0 mg/mL intralesional injection | 0 | 10 | 0 | 10 | 6 | 10 |
| EG003 | 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. Triamcinolone Acetonide 7.5 mg/mL: 7.5 mg/mL intralesional injection | 0 | 10 | 0 | 10 | 10 | 10 |
| EG004 | 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. Triamcinolone Acetonide 10 mg/mL: 10 mg/mL intralesional injection | 0 | 10 | 0 | 10 | 8 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Onychomadesis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Units (fingernails) affected/at risk: 0/10 in the Placebo group 3/16 in the triamcinolone acetonide (TAC) 2.5 mg/mL group 0/17 in the TAC 5.0 mg/mL group 3/16 in the TAC 7.5 mg/mL group 1/14 in the TAC 10 mg/mL group |
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| Subungual hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Units (fingernails) affected/at risk: 0/10 in the Placebo group 1/16 in the triamcinolone acetonide (TAC) 2.5 mg/mL group 1/17 in the TAC 5.0 mg/mL group 1/16 in the TAC 7.5 mg/mL group 0/14 in the TAC 10 mg/mL group |
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| Cuticle retraction | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Units (fingernails) affected/at risk: 0/10 in the Placebo group 1/16 in the triamcinolone acetonide (TAC) 2.5 mg/mL group 3/17 in the TAC 5.0 mg/mL group 6/16 in the TAC 7.5 mg/mL group 6/14 in the TAC 10 mg/mL group |
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| Longitudinal groove | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Units (fingernails) affected/at risk: 0/10 in the Placebo group 0/16 in the triamcinolone acetonide (TAC) 2.5 mg/mL group 0/17 in the TAC 5.0 mg/mL group 2/16 in the TAC 7.5 mg/mL group 0/14 in the TAC 10 mg/mL group |
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| Beau's line(s) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Units (fingernails) affected/at risk: 0/10 in the Placebo group 1/16 in the triamcinolone acetonide (TAC) 2.5 mg/mL group 1/17 in the TAC 5.0 mg/mL group 1/16 in the TAC 7.5 mg/mL group 1/14 in the TAC 10 mg/mL group |
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| Erythronychia | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Units (fingernails) affected/at risk: 0/10 in the Placebo group 1/16 in the triamcinolone acetonide (TAC) 2.5 mg/mL group 1/17 in the TAC 5.0 mg/mL group 2/16 in the TAC 7.5 mg/mL group 2/14 in the TAC 10 mg/mL group |
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| Nail plate split | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Units (fingernails) affected/at risk: 0/10 in the Placebo group 0/16 in the triamcinolone acetonide (TAC) 2.5 mg/mL group 0/17 in the TAC 5.0 mg/mL group 0/16 in the TAC 7.5 mg/mL group 1/14 in the TAC 10 mg/mL group |
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| Nail plate concavity | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Units (fingernails) affected/at risk: 0/10 in the Placebo group 0/16 in the triamcinolone acetonide (TAC) 2.5 mg/mL group 0/17 in the TAC 5.0 mg/mL group 0/16 in the TAC 7.5 mg/mL group 1/14 in the TAC 10 mg/mL group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shari Lipner | Weill Cornell Medicine | 6469623376 | shl9032@med.cornell.edu |
| Dec 2, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009260 | Nail Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D007267 | Injections |
| D014222 | Triamcinolone Acetonide |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Title | Measurements |
|---|---|
| Female |
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| Male |
|
| Title | Measurements |
|---|---|
| Hispanic or Latino |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
| American Indian or Alaska Native |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
|
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| Triamcinolone acetonide 5.0 mg/mL |
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| Triamcinolone acetonide 7.5 mg/mL |
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| Triamcinolone acetonide 10 mg/mL |
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| Placebo |
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| Total |
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| OG003 | 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. Triamcinolone Acetonide 7.5 mg/mL: 7.5 mg/mL intralesional injection |
| OG004 | 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. Triamcinolone Acetonide 10 mg/mL: 10 mg/mL intralesional injection |
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| Placebo |
Participants receive an intralesional injection of 0.1-0.2 mL of normal saline, once per 6 weeks until 24 weeks. |
|
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