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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
Study Summary
This trial is testing how well a lower concentration of intralesional triamcinolone acetonide works to treat nail psoriasis, compared to the standard concentration.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis
Secondary outcome measures
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
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
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,517 Total Patients Enrolled
4 Trials studying Nail Diseases
30 Patients Enrolled for Nail Diseases
Shari Lipner, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
3 Previous Clinical Trials
82 Total Patients Enrolled
1 Trials studying Nail Diseases
20 Patients Enrolled for Nail Diseases
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