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Topical Anesthetics for Lentigo
N/A
Waitlist Available
Led By Murad Alam, MD
Research Sponsored by Northwestern 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 day of treatment
Awards & highlights
Study Summary
This trial will compare how well 3 different topical anesthetics work on patients' pain during treatment for lentigines (age/liver spots) and/or photorejuvenation ( improving skin appearance).
Who is the study for?
This trial is for women aged 25-65 with skin types I-III who have moderate lentigines or photodamage and want laser treatment. They must be in good health, able to consent, and not pregnant. Exclusions include certain medical conditions, recent facial treatments, allergies to anesthetics, chronic pain conditions, liver/kidney disease, or tanned skin.Check my eligibility
What is being tested?
The study tests how well different topical anesthetics reduce pain during Q-switched laser treatment for lentigo. It compares lidocaine/prilocaine (LPTA), lidocaine/tetracaine (LTTA), and a placebo. Patients' pain levels are measured after each treated area using a visual scale.See study design
What are the potential side effects?
Possible side effects of the topical anesthetics may include temporary redness, swelling at the application site, itching or tingling sensations. There's also a risk of allergic reactions for those sensitive to lidocaine, tetracaine or prilocaine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
visual analog score (VAS) pain rating
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: lidocaine 2.5%/prilocaine 2.5% topical anestheticActive Control2 Interventions
Subjects will be screened, assessed, and randomized to be treated with a single pass of the Q-switched 532nm laser after application of LPTA, LTTA, or PV under occlusion to the assigned randomized site.
Group II: lidocaine 7%/tetracaine 7% topical anestheticActive Control2 Interventions
Subjects will be screened, assessed, and randomized to be treated with a single pass of the Q-switched 532nm laser after application of LPTA, LTTA, or PV under occlusion to the assigned randomized site.
Group III: placebo vehiclePlacebo Group2 Interventions
Subjects will be screened, assessed, and randomized to be treated with a single pass of the Q-switched 532nm laser after application of LPTA, LTTA, or PV under occlusion to the assigned randomized site.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,183 Total Patients Enrolled
Murad Alam, MDPrincipal InvestigatorNorthwestern University
69 Previous Clinical Trials
2,532 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a mental illness.You have had multiple episodes of cold sores.You have a severe skin condition, not just mild acne.You have kidney or liver disease.You have a long-term pain condition like fibromyalgia or vulvodynia.You have moderate skin spots and damage from the sun and want to have laser treatment to improve your skin tone.You have experienced skin darkening after laser treatment in the past.You are in good overall health.You are allergic to lidocaine, tetracaine, or prilocaine.You have an infection on your face or upper inner arms, except for mild acne.You are currently taking a medication for heart rhythm problems called a class I anti-arrhythmic medication.You have a suntan or have recently been exposed to a lot of sun.
Research Study Groups:
This trial has the following groups:- Group 1: lidocaine 2.5%/prilocaine 2.5% topical anesthetic
- Group 2: lidocaine 7%/tetracaine 7% topical anesthetic
- Group 3: placebo vehicle
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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