The Effect of Topical Anesthetics on Patients' Pain and Operative Experience During Treatment With QSwitched Laser

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Topical Anesthetic Using Lidocaine 2.5%/Prilocaine 2.5% Versus Lidocaine 7%/Tetracaine 7% Cream on Patients' Pain and Operative Experience During Treatment With QSwitched 532nm Laser

Conditions
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Lentigo

Intervention / Treatment
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* Drug: lidocaine 2.5%/prilocaine 2.5% topical anesthetic
* Drug: lidocaine 7%/tetracaine 7% topical anesthetic
* Drug: placebo vehicle
* Device: Q-switched 532nm Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have moderate lentigines and/or photodamage and desire laser toning. Females 25-65 years of age. In good health. Have Fitzpatrick phototype I-III. Willingness and the ability to understand and provide informed consent and communicate with the investigator/study staff. Exclusion Criteria: Younger than 25 or older than 65 years of age. Pregnant or lactating. Is a male. 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 Has an active infection on the face or upper inner arms (excluding mild acne). Is allergic to lidocaine, tetracaine, or prilocaine. Has kidney disease and/or liver disease. Has G-6-PD and/or pseudocholinesterase deficiency. Is taking a class I anti-arrhythmic medication. Is tanned. Has a history of hyperpigmentation with laser treatment. Has a mental illness. Has a history of a chronic pain condition such as fibromyalgia or vulvodynia. Unable to understand the protocol or to give informed consent. Multiply recurrent episodes of cold sores. Any significant skin disease beyond mild acne. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical clinical study, or would pose as an unacceptable risk to the subject.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine 2.5%/prilocaine 2.5% topical anesthetic<br>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. | Drug: lidocaine 2.5%/prilocaine 2.5% topical anesthetic<br> <br> Device: Q-switched 532nm Laser<br> <br> |
| Active Comparator: lidocaine 7%/tetracaine 7% topical anesthetic<br>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. | Drug: lidocaine 7%/tetracaine 7% topical anesthetic<br> <br> Device: Q-switched 532nm Laser<br> <br> |
| Placebo Comparator: placebo vehicle<br>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. | Drug: placebo vehicle<br> <br> Device: Q-switched 532nm Laser<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog score (VAS) pain rating | Subjects will fill out a visual analog score (VAS) pain rating after treatment with 0 being no pain and 10 being worst pain | Day of treatment |