Ice Versus EMLA for Pain in Laser Hair Removal
This trial is active, not recruiting.
|Treatments||ice pack, topical emla cream|
|Start date||December 2014|
|End date||December 2016|
|Trial size||30 participants|
|Trial identifier||NCT02318654, STU106090|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Pain using the SF-MPQ immediately after treatment
time frame: immediately (at 0 min) after laser treatment
Pain using the SF-MPQ 5 minutes after treatment
time frame: 5 mins after laster treatment
Female participants from 18 years up to 65 years old.
Inclusion Criteria 1. Subjects are Caucasian or Asian females. 2. Subjects are 18-65 years old. 3. Subjects have Fitzpatrick skin type I-III and coarse dark axillary hair. 4. Subjects are in good health. 5. Subjects can provide informed consent. 6. Subjects have the willingness and the ability to understand and communicate with the investigators. Exclusion Criteria 1. Subjects who are allergic to lidocaine or prilocaine. 2. History of methemoglobinemia. 3. History of recurrent petechial or purpuric lesions. 4. Bleeding tendency or coagulopathy. 5. History of laser treatment in axilla. 6. History of keloid or hypertrophic scarring. 7. Pregnant or lactating or intends to become pregnant in the next 3 months. 8. Active skin disease or skin infection in the treatment area. 9. Subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders and cognitive disorders. 10. History of cold urticaria. 11. History of current injury or abnormal skin sensation. 12. Unable to understand the protocol or to give informed consent. 13. 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.
|Official title||Comparing the Efficacy of Ice Pack Versus Topical EMLA for Pain Control in Laser Axillary Hair Removal: A Randomized Control Trial|
|Principal investigator||Murad Alam, MD|
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