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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to Spontaneous Discharge

Secondary outcome measures

Rate of Failure

Other outcome measures

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

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692

40%

Nausea

10%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Tumescent Solution With Dilute Epinephrine

Tumescent Solution With Dilute Lidocaine and Epinephrine

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,531 Total Patients Enrolled

Brian Gulack, MDPrincipal InvestigatorRush University Medical Center

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

LMX 4 Topical Cream (Topical Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05461053 — Phase 4

Skin Abscess Research Study Groups: LMX4-A topical anesthetic application, Warm Compress application

Skin Abscess Clinical Trial 2023: LMX 4 Topical Cream Highlights & Side Effects. Trial Name: NCT05461053 — Phase 4

LMX 4 Topical Cream (Topical Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05461053 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in this clinical research study?

"Indeed, the information featured on clinicaltrials.gov implies that this medical study is presently seeking participants. The experiment was initially posted on 11/1/2022 and has since been revised as of 10/31/2022. Approximately 300 patients must be recruited from 1 facility."

Answered by AI

Has LMX4 been officially accepted by the Food and Drug Administration?

"LMX4 is approved for use, so our team at Power has assigned it a score of 3 in terms of safety. This is because Phase 4 trials are the last stage before approval."

Answered by AI

Is the age requirement for this experimental research limited to those above 25 years old?

"As indicated in the inclusion criteria, this medical trial is open to any participant aged between 2 and 18. Furthermore, 15 other trials are available for people under 18 years old and 51 more clinical studies are accessible for those over 65."

Answered by AI

Am I eligible to become a participant in this research?

"This research requires 300 patients with cutaneous abscess between two and eighteen years of age. The key criteria these participants must satisfy include being less than 18, one localized soft tissue lesion smaller than three centimeters according to imaging or clinical examination results."

Answered by AI

Are enrollment opportunities still open for this medical trial?

"Confirmed. Clinicaltrials.gov reveals that this investigation, which was posted on November 1st 2022, is currently looking for participants. In total, 300 individuals must be recruited from one medical facility to complete the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Conservative Management of Cutaneous Abscess

2025. "Conservative Management of Cutaneous Abscess". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05461053.