Clinical trial NCT03991936: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nail Psoriasis
Nail Diseases
Keywords: Nail Psoriasis
Nail Diseases
Triamcinolone acetonide
Triamcinolone
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis
timeFrame: 24 weeks (end of study)
Secondary outcomes:
measure: Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)
timeFrame: Baseline, 24 weeks (end of study)
measure: Change From Baseline in Nail Psoriasis Qualify of Life, as Measured by Development and Validation of Nail Psoriasis Quality of Life Scale (NPQ10)
timeFrame: Baseline, 24 weeks (end of study)
measure: Number of Participants With at Least One Adverse Event
timeFrame: 24 weeks (end of study)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Shari Lipner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: