Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis

Study Purpose

This purpose of this study is to determine the lowest effective concentration of intralesional triamcinolone acetonide in the treatment of nail psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03991936
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Weill Medical College of Cornell University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Shari Lipner, MD, PhD
Principal Investigator Affiliation Weill Medical College of Cornell University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Nail Psoriasis, Nail Diseases
Arms & Interventions

Arms

Placebo Comparator: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.

Interventions

Drug: - Placebos

Normal saline intralesional injection

Drug: - Triamcinolone Acetonide 2.5 mg/mL

2.5 mg/mL intralesional injection

Drug: - Triamcinolone Acetonide 5.0 mg/mL

5.0 mg/mL intralesional injection

Drug: - Triamcinolone Acetonide 7.5 mg/mL

7.5 mg/mL intralesional injection

Drug: - Triamcinolone Acetonide 10 mg/mL

10 mg/mL intralesional injection

Contact a Trial Team

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New York, New York

Status

Recruiting

Address

Weill Medical College of Cornell University

New York, New York, 10021

Site Contact

Shari Lipner, MD, PhD

[email protected]

646-962-3376

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