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Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis
Phase 4
Waitlist Available
Led By Shari Lipner, MD, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks (end of study)
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial aims to find the lowest effective dose of a steroid injection to treat nail psoriasis by reducing swelling and irritation. Steroid injections have been used as a conventional treatment for nail psoriasis, but pain is often a limitation.
Eligible Conditions
- Nail Diseases
- Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks (end of study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks (end of study)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis
Secondary study objectives
Change From Baseline in Nail Psoriasis Qualify of Life, as Measured by Development and Validation of Nail Psoriasis Quality of Life Scale (NPQ10)
Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)
Number of Participants With at Least One Adverse Event
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Triamcinolone Acetonide 7.5 mg/mLExperimental Treatment1 Intervention
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.
Group II: Triamcinolone Acetonide 5.0 mg/mLExperimental Treatment1 Intervention
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.
Group III: Triamcinolone Acetonide 2.5 mg/mLExperimental Treatment1 Intervention
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.
Group IV: Triamcinolone Acetonide 10 mg/mLExperimental Treatment1 Intervention
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.
Group V: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triamcinolone Acetonide 10 mg/mL
2020
Completed Phase 4
~20
Triamcinolone Acetonide 2.5 mg/mL
2020
Completed Phase 4
~20
Triamcinolone Acetonide 5.0 mg/mL
2020
Completed Phase 4
~20
Triamcinolone Acetonide 7.5 mg/mL
2020
Completed Phase 4
~20
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,734 Total Patients Enrolled
4 Trials studying Nail Diseases
31 Patients Enrolled for Nail Diseases
Shari Lipner, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
4 Previous Clinical Trials
92 Total Patients Enrolled
1 Trials studying Nail Diseases
20 Patients Enrolled for Nail Diseases