Topical Anesthetics for Lentigo

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: Class I anti-arrhythmics

Disqualifiers: Pregnancy, Male, Kidney disease, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking a class I anti-arrhythmic medication.

What data supports the effectiveness of the drug lidocaine 2.5%/prilocaine 2.5% topical anesthetic and lidocaine 7%/tetracaine 7% topical anesthetic for treating lentigo?

Research shows that lidocaine/tetracaine cream is effective in reducing pain during dermatologic procedures, making it a promising option for similar skin treatments. The combination of lidocaine and tetracaine has been found to provide effective pain relief with mild side effects, which could be beneficial for treating lentigo. ^{1 2 3 4 5}

Is the lidocaine/tetracaine topical anesthetic safe for use in humans?

The lidocaine/tetracaine cream is considered safe for use in humans, with mild side effects reported in clinical trials, making it a favorable option compared to other topical anesthetics. ^{1 2 3 4 5}

How does the topical anesthetic treatment for lentigo differ from other treatments?

The topical anesthetic treatment for lentigo is unique because it involves the application of anesthetic creams like lidocaine and prilocaine, which are typically used for numbing the skin before minor procedures. This approach is novel for lentigo as it focuses on providing local anesthesia to the skin, potentially making the treatment more comfortable compared to other methods that may not address pain management directly. ^{1 2 3 6 7}

What is the purpose of this trial?

This study will conduct a split-face and -body randomized control trial to compare lidocaine 2.5%/prilocaine 2.5% topical anesthetic (LPTA), lidocaine 7%/tetracaine 7% topical anesthetic (LTTA), and placebo vechicle (PV) on patients' pain perceptions with Q-switched 532nm laser for the treatment of lentigines and/or photorejuvenation.Subjects will fill out a pain score on a visual analog scale (VAS) with 0 being no pain and 10 being most pain after each treatment area is completed.

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

Females 25-65 years of age

Have Fitzpatrick phototype I-III

You have moderate skin spots and damage from the sun and want to have laser treatment to improve your skin tone.

Exclusion Criteria

Pregnant or lactating

Has G-6-PD and/or pseudocholinesterase deficiency

Has received the following treatments on the face: ablative or non-ablative laser procedure in the past 3 months, radiofrequency device treatment in the past 3 months, ultrasound device treatment in the past 3 months, medium to deep chemical peel in the past 3 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single pass of the Q-switched 532nm laser after application of topical anesthetics or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain perception using a visual analog scale after treatment

1 day

1 visit (in-person)

Treatment Details

Interventions

• lidocaine 2.5%/prilocaine 2.5% topical anesthetic
• lidocaine 7%/tetracaine 7% topical anesthetic
• placebo vehicle

Trial Overview 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.

Participant Groups

Group I: lidocaine 2.5%/prilocaine 2.5% topical anesthetic Active Control 2 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 anesthetic Active Control 2 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 vehicle Placebo Group 2 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

In a study involving 40 subjects undergoing superficial dermatosurgical procedures, the combination cream of 7% lignocaine and 7% tetracaine provided significantly better pain relief compared to the 2.5% lidocaine and 2.5% prilocaine cream, as measured by visual analogue scale scores.

The findings suggest that the lignocaine/tetracaine combination is an effective topical anesthetic for short-term use (30 minutes), allowing for quicker onset of analgesia and potentially improving the efficiency of dermatological procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Topical Anesthetics for Radiofrequency Ablation of Achrocordons: Eutectic Mixture of Lignocaine/Prilocaine versus Lidocaine/Tetracaine. Gahalaut, P., Mishra, N., Chauhan, S., et al.[2021]

Lidocaine/tetracaine cream (Pliaglis) is a newer topical anesthetic that effectively reduces pain during cosmetic dermatologic procedures, as shown in multiple clinical trials.

This combination anesthetic is favored for its ease of use and mild side effects compared to other topical anesthetics, making it a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of lidocaine/tetracaine cream as a topical anesthetic for dermatologic laser procedures. Alster, T.[2021]

A topical gel containing 2.5% lidocaine and 3.5% prilocaine significantly reduced discomfort during 35% trichloroacetic acid (TCA) peels, with 8 out of 10 patients reporting at least a 40% decrease in pain compared to previous peels without anesthesia.

While effective in pain reduction, the gel may increase the depth of the peel, suggesting it should only be used with TCA concentrations below 30% to avoid potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a topical lidocaine/prilocaine anesthetic gel in 35% trichloroacetic acid peels. Rubin, MG.[2019]

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Comparison of Topical Anesthetics for Radiofrequency Ablation of Achrocordons: Eutectic Mixture of Lignocaine/Prilocaine versus Lidocaine/Tetracaine. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Provision of anesthesia with single application of lidocaine 2% gel. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Efficacy of 2% lidocaine injection as a topical agent in cataract surgery. [2016]

4. Italy pubmed.ncbi.nlm.nih.gov

Topical anesthetics for cosmetic dermatologic procedures. [2018]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Review of lidocaine/tetracaine cream as a topical anesthetic for dermatologic laser procedures. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Design and evaluation of lidocaine- and prilocaine-coloaded nanoparticulate drug delivery systems for topical anesthetic analgesic therapy: a comparison between solid lipid nanoparticles and nanostructured lipid carriers. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The efficacy of a topical lidocaine/prilocaine anesthetic gel in 35% trichloroacetic acid peels. [2019]