External thermomechanical device delivering cold and vibration stimuli for Nail Diseases

Phase 4

Waitlist Available

Led By Shari R 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 prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test whether a device that delivers vibration and cold stimuli can lower pain during intramatricial nail injections.

Eligible Conditions

Nail Diseases

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The level of pain and change in pain between each time point will be assessed using the Wong-Baker FACES scale with use of thermomechanical device delivering stimuli, without delivering stimuli, and with use of ethyl chloride skin refrigerant spray.

Secondary study objectives

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

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: External thermomechanical device delivering stimuliExperimental Treatment1 Intervention

The thermomechanical device is placed on the digit proximally to the injection site with the ice wings frozen and the vibration mechanism switched on.

Group II: Nail injection with ethyl chloride skin refrigerant sprayActive Control1 Intervention

Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion

Group III: External thermomechanical device without delivering stimuliPlacebo Group1 Intervention

The thermomechanical device is placed on the digit proximally to the injection site with the ice wings at room temperature (unfrozen) and the vibration mechanism switched off.

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