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Topical Anesthetic
BLT vs Lidocaine for Procedural Pain
Phase 4
Recruiting
Led By Brian J Simmons, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women over 18, but not more than 75 years of age
Be older than 18 years old
Must not have
Pregnant women and women who are breastfeeding
Patients with cardiac/respiratory disease, seizure disorder, or neuropathies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial aims to test a new numbing cream called BLT to see if it works better than the standard Lidocaine cream in reducing pain during certain cosmetic procedures.
Who is the study for?
This trial is for individuals experiencing pain during specific skin procedures like IPL (intense pulsed light), PDL (pulsed dye laser), and microneedling. Details on who can join or reasons for exclusion are not provided.
What is being tested?
The study aims to compare the effectiveness of a compounded anesthetic cream called BLT (Benzocaine/Lidocaine/Tetracaine) with a standard 4% Lidocaine cream in reducing pain from certain dermatological procedures.
What are the potential side effects?
Potential side effects may include local reactions such as redness, swelling, itching at the application site, and rare allergic responses. Systemic side effects are uncommon but could involve nervous system or cardiovascular symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently pregnant or breastfeeding.
Select...
I have a heart, lung condition, seizures, or nerve problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain as measured by the Numeric Pain Rating Scale (NPRS)
Pain as measured by the Wong-Baker Face Pain Rating Scale
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Left Side LidocaineExperimental Treatment2 Interventions
Subjects will receive topical 4% Lidocaine applied to the left side of the face and 4% BLT applied to the right side of the face prior to treatment.
Group II: Left Side BLTExperimental Treatment2 Interventions
Subjects will receive topical BLT applied to the left side of the face and 4% Lidocaine applied to the right side of the face prior to treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine topical
2018
Completed Phase 4
~320
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
539 Previous Clinical Trials
2,539,705 Total Patients Enrolled
Brian J Simmons, MDPrincipal InvestigatorDartmouth Health