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Topical Anesthetic

LMX 4 Topical Cream for Skin Abscess

Phase 4

Waitlist Available

Led By Brian Gulack, MD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment + 7-14 days

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This triallooks at anesthetic cream to reduce time to drainage & hospital visits for children's abscesses. It also measures patient experience to improve evidence & cost-effectiveness.

Who is the study for?

This trial is for children under 18 with a small, single skin abscess less than 3 cm wide. It's not for those who've used antibiotics or had drainage attempts in the past week, have current abscess drainage, lidocaine allergies, signs of serious infection like high fever or lethargy, need surgical drainage by doctor's decision, are hospitalized or immunocompromised.

What is being tested?

The study tests if LMX 4 Topical Cream helps superficial skin abscesses drain without surgery compared to just using warm compresses and waiting. Kids will be randomly chosen to get either the cream or usual care and tracked for how quickly their abscess drains and if they return for more treatment.

What are the potential side effects?

Potential side effects may include reactions at the cream application site such as redness, itching or swelling. Since it contains lidocaine, there could also be symptoms related to its absorption like dizziness or numbness around the mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment + 7-14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment + 7-14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment + 7-14 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time to Spontaneous Discharge

Secondary study objectives

Rate of Failure

Other study objectives

Global Health PROMIS Parent Proxy Scale v1.0 - Global Health 7+2

Global Health PROMIS Pediatric Scale v1.0 - Global Health 7+2

Pain Interference PROMIS Parent Proxy Item Bank v2.0 - Pain Interference

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LMX4-A topical anesthetic applicationExperimental Treatment1 Intervention

The intervention group will be prescribed a course of LMX4 with application of a non-permeable dressing (Tegaderm, 3M, St Paul, MN) until time of spontaneous drainage, treatment failure, or resolve of pain. LMX4 is a topical anesthetic consisting of 4% lidocaine which is Food and Drug Administration (FDA) approved for topical use in children.

Group II: Warm Compress applicationActive Control1 Intervention

The control group will receive instructions on applying warm compresses, the current standard of care. The patient or parent/guardian will be directed to apply a warm compress to the abscess or soak the area in warm water for 15 minutes. The application/soak will be done 4 times during the day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LMX 4 Topical Cream

2017

Completed Phase 1

~10

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