Phase 4
N=55
Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis
Nail Psoriasis · Nail Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03991936 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis — 2.5 mg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebos (Drug); Triamcinolone Acetonide 2.5 mg/mL (Drug); Triamcinolone Acetonide 5.0 mg/mL (Drug); Triamcinolone Acetonide 7.5 mg/mL (Drug); Triamcinolone Acetonide 10 mg/mL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis |
2.5 | — |
| SECONDARY Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI) |
-0.96; -3.96; -2.96; -3.53; -3.93 | <0.001 sig |
| SECONDARY 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 | — |
| SECONDARY Number of Participants With at Least One Adverse Event |
3; 4; 7; 8; 0 | — |
Summary
This purpose of this study is to determine the lowest effective concentration of intralesional triamcinolone acetonide in the treatment of nail psoriasis.
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
Data sourced from ClinicalTrials.gov (NCT03991936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.