Lidocaine/Tetracaine Ointment vs Lidocaine/Prilocaine Cream for Photoaging

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Mayo Clinic

Must not be taking: Isotretinoin, Corticosteroids

Disqualifiers: Pregnancy, Severe cardiovascular, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which topical anesthetic provides better pain relief before a nonablative laser treatment for sun-damaged skin: a lidocaine/tetracaine ointment or a lidocaine/prilocaine cream. Participants will receive treatment with the ointment on one side of their face and the cream on the other to compare effectiveness. The trial seeks individuals in good health with mild facial sun damage who plan to undergo this specific laser treatment. As a Phase 2/3 trial, the study measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants an opportunity to contribute to important research.

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've taken isotretinoin in the last 3 months or systemic corticosteroids in the last month.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that a lidocaine 23%/tetracaine 7% ointment is generally safe for use in skin procedures. Tested on 2,159 people, the results suggest safety. However, the FDA has not officially approved it as safe or effective, so users should keep this in mind.

The lidocaine 2.5%/prilocaine 2.5% cream is widely used to numb the skin before procedures and is not considered dangerous. Research shows it is commonly applied for this purpose, and no major safety issues have been reported. However, one of its by-products has shown a potential cancer risk in mice and rats.

Both treatments have been used in various settings, but it is important to consider all information and consult healthcare providers when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for photoaging because they offer different approaches to managing discomfort during laser procedures. The lidocaine/tetracaine ointment is unique due to its high concentration of anesthetics, which might provide a more effective numbing effect without the need for occlusion, potentially offering greater convenience and comfort. On the other hand, the lidocaine/prilocaine cream uses occlusion, which can enhance the cream's absorption and effectiveness. These options could provide more tailored pain management solutions compared to traditional methods, improving the overall experience for patients undergoing cosmetic laser treatments.

What evidence suggests that this trial's treatments could be effective for photoaging?

This trial will compare the effectiveness of two treatments for reducing pain during laser treatment for photoaging. One treatment arm uses an ointment with 23% lidocaine and 7% tetracaine. Studies have shown this combination effectively reduces pain during procedures like soft tissue augmentation, with patients reporting less discomfort compared to a placebo. The other treatment arm uses a cream with 2.5% lidocaine and 2.5% prilocaine, known as EMLA, commonly used to numb the skin for minor procedures. Although EMLA is effective, some research suggests it might not be as strong as other options. Both treatments are generally safe, with mostly mild side effects reported. ^{3 6 7 8 9}

Who Is on the Research Team?

Elika Hoss

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults in good health with mild to moderate facial photoaging, who are undergoing a specific laser treatment. Women must use birth control if of childbearing potential. Excluded are those with certain skin conditions, severe diseases, recent use of isotretinoin or steroids, allergies to the anesthetics used, and pregnant or breastfeeding women.

Inclusion Criteria

Fitzpatrick skin type I-IV with at least mild photodamage of the face by physician discretion

Subject has completed an appropriately administered informed consent process which includes signing the institutional review board (IRB) approved consent form

Female patients will be either of non-childbearing potential defined as: Having no uterus; No menses for at least 12 months; or (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as: Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device; Intrauterine coil; Bilateral tubal ligation; Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom); Abstinence (if practicing abstinence must agree to use barrier method described above if becomes sexually active); Vasectomized partner (Must agree to use barrier method described above if becomes sexually active with non-vasectomized)

Exclusion Criteria

You have a wound that hasn't fully healed or a skin condition in the area where the treatment will be given.

Subjects with any pre-existing medical or psychological condition which, in the opinion of the investigator, would put them at increased risk due to study treatment or participation

Subjects who are unable to comprehend the study consent document or provide full written consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Application of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream followed by fractional thulium fiber laser treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for self-reported pain, itching, and burning after laser treatment

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine 23%/Tetracaine 7% Ointment
• Lidocaine 2.5%/Prilocaine 2.5% Cream

Trial Overview The study compares two topical anesthetics: lidocaine/tetracaine ointment without occlusion versus lidocaine/prilocaine cream with occlusion before nonablative laser procedures on the face. The goal is to see which one is more effective at numbing the skin.

How Is the Trial Designed?

Group I: 2.5 g of lidocaine 23% / tetracaine 7% ointment Active Control 1 Intervention

Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care will have randomly assigned half of the face applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion for 60 minutes.

Group II: 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream Active Control 1 Intervention

Patients undergoing 1927 nm fractional thulium fiber laser treatment of the face for photodamage as part of normal clinical care will have randomly assigned half of the face applied with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion for 60 minutes.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

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/prilocaine cream (EMLA) significantly reduces venipuncture pain after 60 minutes of application, showing consistent efficacy across different skin pigmentation types in a study of 60 volunteers.

The effectiveness of EMLA cream does not improve with longer application times (up to 120 minutes), confirming its safety and reliability as a topical anesthetic for all skin types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the analgesic efficacy of EMLA cream in volunteers with differing skin pigmentation undergoing venipuncture. Riendeau, LA., Bennett, D., Black-Noller, G., et al.[2019]

Amethocaine gel provides similar pain relief to lidocaine-prilocaine cream for children undergoing Port-a-Cath puncture, but with a significantly shorter application time of 30 minutes compared to 60 minutes for lidocaine-prilocaine.

Both anesthetics were found to be safe, with no serious adverse effects reported, and pain assessments were generally consistent across different age and gender groups, although nurses rated pain higher for younger children and males when using lidocaine-prilocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative efficacy of amethocaine gel and lidocaine-prilocaine cream for Port-a-Cath puncture in children. Bishai, R., Taddio, A., Bar-Oz, B., et al.[2019]

In a study involving 125 patients, prilocaine was found to be significantly more comfortable than lignocaine for local anaesthesia during minor eyelid procedures, with a mean pain score of 1.82 compared to 3.19 for lignocaine.

The results were statistically significant (p < 0.001), indicating that prilocaine may be a preferable choice for reducing discomfort in these types of procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prilocaine versus lignocaine for minor lid procedures. Burton, AJ., Backhouse, O., Metcalfe, TW.[2022]

In a study involving children aged 1-15 years, lidocaine-prilocaine cream was found to be significantly more effective than tetracaine 4% cream for pain relief during venipuncture, with 97% of patients receiving lidocaine-prilocaine reporting adequate pain relief compared to 76% for tetracaine.

Despite the statistical superiority of lidocaine-prilocaine, the clinical significance of the difference is minor, and tetracaine offers practical advantages such as a shorter application time, vasodilation effects, and lower cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tetracaine versus lidocaine-prilocaine for preventing venipuncture-induced pain in children. van Kan, HJ., Egberts, AC., Rijnvos, WP., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4645143/

Comparative Efficacy and Patient Preference of Topical ... Our objective was to compare the efficacy and patient preference of three commonly used topical anaesthetics: (2.5% lidocaine/2.5% prilocaine cream (EMLA®), 4% ...

2. jaad.org jaad.org/article/S0190-9622%2824%2900126-9/fulltext

Comparative effectiveness of short contact (30-minute) ... Comparative effectiveness of short contact (30-minute) lidocaine-prilocaine vs lidocaine-tetracaine topical anesthetic mixtures for cutaneous ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37828535/

Dermal effects and pharmacokinetic evaluation of the ... Conclusion: The method described a model for investigations of pharmacokinetics and pharmacodynamics of topical lidocaine/prilocaine cream.

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/019941s021lbl.pdf

EMLA CREAM (lidocaine 2.5% and Prilocaine 2.5%) The data from 121 patients demonstrated that EMLA Cream was not effective as a sole anesthetic agent in managing the pain from the surgical procedure. The ...

5. jcadonline.com jcadonline.com/evaluation-of-the-efficacy-and-safety-of-a-lidocaine-and-tetracaine-77-cream-for-induction-of-local-dermal-anesthesia-for-facial-soft-tissue-augmentation-with-hyaluronic-acid/

Evaluation of the Efficacy and Safety of a Lidocaine ... In summary, the results of this trial indicate that LT cream provides effective pain relief for facial soft tissue augmentation with hyaluronic acid injections.

6. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9AKORN_LIDOCAINE_AND_PRILOCAINE_CREAM.pdf

SDS: Lidocaine 2.5% and Prilocaine 2.5% Cream Hazards Not Otherwise Classified: Not classifiable. Supplementary Information: While this material is not classifiable as hazardous under the OSHA standard, ...

7. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9GLOBA_LIDOCAINE_PRIL_CRM.pdf

Safety Data Sheet Carcinogenicity. Not listed as a carcinogen, however, a metabolic by-product of prilocaine, ortho- toluidine, has been shown to cause cancer in mice and rats.

8. webmd.com webmd.com/drugs/2/drug-2358-8170/emla-topical/lidocaine-prilocaine-cream-topical/details

Lidocaine/Prilocaine (Emla) - Uses, Side Effects, and More Find patient medical information for Lidocaine/Prilocaine (Emla) on WebMD including its uses, side effects and safety, interactions, ...

9. walgreens.com walgreens.com/rx-druginfo/drug-name?drugId=705334

Lidocaine/priloc 2.5% Cream 5x5gm | Drug Details Get accurate drug information on prescription and OTC medications at Walgreens.com, along with resources for Rx and health services to manage your health.