Nail Diseases, Nail Psoriasis
Conditions
Keywords
Nail Psoriasis, Nail Diseases, Triamcinolone acetonide, Triamcinolone
Brief summary
This purpose of this study is to determine the lowest effective concentration of intralesional triamcinolone acetonide in the treatment of nail psoriasis.
Interventions
DRUGPlacebos
Normal saline intralesional injection
DRUGTriamcinolone Acetonide 2.5 mg/mL
2.5 mg/mL intralesional injection
DRUGTriamcinolone Acetonide 5.0 mg/mL
5.0 mg/mL intralesional injection
DRUGTriamcinolone Acetonide 7.5 mg/mL
7.5 mg/mL intralesional injection
10 mg/mL intralesional injection
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis | 24 weeks (end of study) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) | Baseline, 24 weeks (end of study) | 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) | Baseline, 24 weeks (end of study) | 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. |
| Number of Participants With at Least One Adverse Event | 24 weeks (end of study) | Adverse events will only include those that are determined to be related to the study drug. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from one location in the United States
Pre-assignment details
A total of 11 participants passed screening and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 82 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) Placebo | 4.7 score on a scale |
| Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) Total | 4.9 score on a scale |
| Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) Triamcinolone acetonide 10 mg/mL | 5.0 score on a scale |
| Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) Triamcinolone acetonide 2.5 mg/mL | 5.3 score on a scale |
| Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) Triamcinolone acetonide 5.0 mg/mL | 4.76 score on a scale |
| Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) Triamcinolone acetonide 7.5 mg/mL | 4.75 score on a scale |
| Nail Psoriasis Qualify of Life, as Measured by Development and Validation of Nail Psoriasis Quality | 7 percentage of NPQ10 score |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 4 / 10 | 6 / 10 | 10 / 10 | 8 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 24 weeks (end of study)
Population: Per protocol defined as participants completing 24-week follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Groups | Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis | 2.5 mg/mL |
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.
Time frame: Baseline, 24 weeks (end of study)
Population: Per protocol population, defined as participants completing 24-week follow-up visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Groups | Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) | -0.96 score on a scale |
| Triamcinolone Acetonide 2.5 mg/mL | Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) | -3.96 score on a scale |
| Triamcinolone Acetonide 5.0 mg/mL | Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) | -2.96 score on a scale |
| Triamcinolone Acetonide 7.5 mg/mL | Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) | -3.53 score on a scale |
| Triamcinolone Acetonide 10 mg/mL | Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) | -3.93 score on a scale |
Comparison: The null hypothesis was that the change from baseline to 24 weeks in the Nail Psoriasis Severity Index (NAPSI) for the triamcinolone acetonide groups: 2.5 mg/mL, 5.0 mg/mL, 7.5 mg/mL, and 10 mg/mL would be no different than the change from baseline to 24 weeks for the placebo group.p-value: <0.001t-test, 2 sided
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.
Time frame: Baseline, 24 weeks (end of study)
Population: Per protocol population, defined as participants completing the 24-week follow-up visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Groups | Change From Baseline in Nail Psoriasis Qualify of Life, as Measured by Development and Validation of Nail Psoriasis Quality of Life Scale (NPQ10) | 4.5 percentage of NPQ10 score |
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.
Time frame: 24 weeks (end of study)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Groups | Number of Participants With at Least One Adverse Event | 3 Participants |
| Triamcinolone Acetonide 2.5 mg/mL | Number of Participants With at Least One Adverse Event | 4 Participants |
| Triamcinolone Acetonide 5.0 mg/mL | Number of Participants With at Least One Adverse Event | 7 Participants |
| Triamcinolone Acetonide 7.5 mg/mL | Number of Participants With at Least One Adverse Event | 8 Participants |
| Triamcinolone Acetonide 10 mg/mL | Number of Participants With at Least One Adverse Event | 0 Participants |