Anesthesia, Local, Photodamaged Skin, Topical and Infiltration Anesthetic Toxicity
Conditions
Brief summary
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.
Detailed description
Lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream are both topical anesthetics that are used commonly to locally anesthetize the skin prior to laser procedures. With the increased use of powerful lasers for medical and cosmetic purposes, adequate pain control is necessary. This study will compare the efficacy of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream in reducing self-reported pain after laser treatment. It will also aim to determine the amount of redness, burning and itching a patient experiences with each cream, and if any symptoms of lidocaine toxicity are experienced. Prior to the procedure, we will randomly assign half of the face to be applied with 2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion and the other half of the face with 7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion. After 60 minutes we will remove the creams with soap and water. Next, the patient will be treated with a fractional thulium fiber laser with a fluence of 20 millijoules and treatment level of 7-11. Standard post procedure instructions will be given, and surveys on symptoms and pain will be completed by both patient and investigator.
Interventions
DRUG2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion
Topical anesthetic used to numb the skin prior to laser procedures
DRUG7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion
Topical anesthetic used to numb the skin prior to laser procedures
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female in general good health.18 years of age or older. * Undergoing 1927nm fractional thulium laser treatment. * 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. * Willingness to have facial exams and digital photos performed of the face. * 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: 1. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device; 2. Intrauterine coil; 3. Bilateral tubal ligation; 4. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom); 5. Abstinence (if practicing abstinence must agree to use barrier method described above if becomes sexually active); 6. Vasectomized partner (Must agree to use barrier method described above if becomes sexually active with non-vasectomized).
Exclusion criteria
* Presence of incompletely healed wound or active skin disease within in treatment area. * Pregnant, planning pregnancy or breastfeeding during the course of the study. * Individuals who have ablative laser within 6 months; non ablative lasers, facial peels, or dermabrasion within 1 month. * Individuals with known allergies or sensitivities to any of the ingredients of any topical products being used in this study (a list of the products with active and excipients will be provided below). * 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. * Subjects who have taken isotretinoin within 3 months or systemic corticosteroids within 1 month. * Subjects with history of severe cardiovascular disease, kidney disease, liver disease, uncontrolled diabetes, uncontrolled seizures, immunosuppression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Pain After Laser Treatment | After laser treatment, approximately 60 minutes | Participants were asked to rate their pain using the self-reported visual analog scale (VAS). The VAS uses a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 10, with lower scores indicating lower pain and higher scores indicating greater pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Self-reported Itching After Laser Treatment | After laser treatment, approximately 60 minutes | The number of participants who reported itching sensation after use of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream. |
| Number of Participants Who Self-reported Burning After Laser Treatment | After laser treatment, approximately 60 minutes | The number of participants who reported burning sensation after use of lidocaine 23% / tetracaine 7% ointment and lidocaine 2.5%/ prilocaine 2.5% cream. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElika Hoss
Mayo Clinic
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
None listed