Ice Versus EMLA for Pain in Laser Hair Removal

Study Overview
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Brief Summary
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The primary objective of this study is to compare the efficacy of ice pack to topical eutectic mixture of local anesthesia (EMLA) for pain control in diode 810 nm laser axillary hair removal. This study is a pilot study designed to determine feasibility of these procedures.

Official Title
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Comparing the Efficacy of Ice Pack Versus Topical EMLA for Pain Control in Laser Axillary Hair Removal: A Randomized Control Trial

Conditions
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Hair Removal

Intervention / Treatment
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* Other: Ice Pack
* Drug: Topical EMLA cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects are Caucasian or Asian females. Subjects are 18-65 years old. Subjects have Fitzpatrick skin type I-III and coarse dark axillary hair. Subjects are in good health. Subjects can provide informed consent. Subjects have the willingness and the ability to understand and communicate with the investigators. Exclusion Criteria Subjects who are allergic to lidocaine or prilocaine. History of methemoglobinemia. History of recurrent petechial or purpuric lesions. Bleeding tendency or coagulopathy. History of laser treatment in axilla. History of keloid or hypertrophic scarring. Pregnant or lactating or intends to become pregnant in the next 3 months. Active skin disease or skin infection in the treatment area. Subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders and cognitive disorders. History of cold urticaria. History of current injury or abnormal skin sensation. Unable to understand the protocol or to give informed consent. 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 subject.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ice Pack<br> | Other: Ice Pack<br>* Subjects will have 600 grams of ice in clear plastic bag size 18 x 23 cm applied to the randomized axilla for 10 minutes. After 10 minutes, the ice pack will be removed and laser hair treatment will be performed.<br>|
| Active Comparator: Topical EMLA cream<br> | Drug: Topical EMLA cream<br>* Topical EMLA will be applied approximately 2 mm thick to the randomized axilla with a wooden tongue depressor wrapped with impermeable plastic occlusion dressing for 60 minutes. After 60 minutes, the drug will be removed with regular gauze and saline and laser hair treatment will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain using the SF-MPQ immediately after treatment |  | immediately (at 0 min) after laser treatment | 
| Pain using the SF-MPQ 5 minutes after treatment |  | 5 mins after laster treatment |