Lidocaine/Tetracaine Ointment vs Lidocaine/Prilocaine Cream for Photoaging
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine the efficacy of lidocaine 2.5%/prilocaine 2.5% cream versus lidocaine 23%/tetracaine 7% ointment for topical anesthesia prior to a nonablative laser procedure.
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.
How does the drug Lidocaine/Tetracaine Ointment differ from Lidocaine/Prilocaine Cream for treating photoaging?
Research Team
EH
Elika Hoss
Principal Investigator
Mayo Clinic
Eligibility Criteria
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)
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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
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Timeline
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)
Treatment Details
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.
Participant Groups
2Treatment groups
Active Control
Group I: 2.5 g of lidocaine 23% / tetracaine 7% ointmentActive Control1 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% creamActive Control1 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Trials
3,427
Recruited
3,221,000+
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]
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]
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]
References
Comparison of Topical Anesthetics for Radiofrequency Ablation of Achrocordons: Eutectic Mixture of Lignocaine/Prilocaine versus Lidocaine/Tetracaine. [2021]
Tetracaine versus lidocaine-prilocaine for preventing venipuncture-induced pain in children. [2019]
Relative efficacy of amethocaine gel and lidocaine-prilocaine cream for Port-a-Cath puncture in children. [2019]
Evaluation of the analgesic efficacy of EMLA cream in volunteers with differing skin pigmentation undergoing venipuncture. [2019]
Prilocaine versus lignocaine for minor lid procedures. [2022]
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