← Back to Search

Triamcinolone Acetonide 10 mg/mL for Nail Diseases

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks (end of study) for reporting.

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