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Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis
Phase 4 trial testing Placebos in Nail Psoriasis in 11 participants. Completed in 29 March 2023.
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 11 March 2020 |
| Primary completion | 29 March 2023 |
| Estimated completion | 29 March 2023 |
| Sites | 1 location across United States |
Weill Medical College of Cornell University
18 and older, any sex, with Nail Psoriasis or Nail Diseases. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| All Groups | 2.5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.96 | -1.81 – -0.11 |
| Triamcinolone Acetonide 2.5 mg/mL | -3.96 | -4.64 – -3.27 |
| Triamcinolone Acetonide 5.0 mg/mL | -2.96 | -3.62 – -2.31 |
| Triamcinolone Acetonide 7.5 mg/mL | -3.53 | -4.2 – -2.85 |
| Triamcinolone Acetonide 10 mg/mL | -3.93 | -4.62 – -3.24 |
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.
| Group | Value | 95% CI |
|---|---|---|
| All Groups | 4.5 | 0 – 15 |
Adverse events will only include those that are determined to be related to the study drug.
| Group | Value | 95% CI |
|---|---|---|
| Triamcinolone Acetonide 2.5 mg/mL | 3 | |
| Triamcinolone Acetonide 5.0 mg/mL | 4 | |
| Triamcinolone Acetonide 7.5 mg/mL | 7 | |
| Triamcinolone Acetonide 10 mg/mL | 8 | |
| Placebo | 0 |
Time frame: 24 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Triamcinolone Acetonide 2.… | Triamcinolone Acetonide 5.… | Triamcinolone Acetonide 7.… | Triamcinolone Acetonide 10… |
|---|---|---|---|---|---|---|
| Cuticle retraction | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Onychomadesis | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Erythronychia | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Subungual hematoma | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Longitudinal groove | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Beau's line(s) | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Nail plate split | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Nail plate concavity | Skin and subcutaneous tissue disorders | — | — | — | — | — |
Data from ClinicalTrials.gov NCT03991936 adverse events section.
This purpose of this study is to determine the lowest effective concentration of intralesional triamcinolone acetonide in the treatment of nail psoriasis.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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