The Effect of Topical Anesthetics on Patients' Pain and Operative Experience During Treatment With QSwitched Laser
This trial is active, not recruiting.
|Treatments||lidocaine 2.5%/prilocaine 2.5% topical anesthetic, lidocaine 7%/tetracaine 7% topical anesthetic, placebo vehicle, q-switched 532nm laser|
|Start date||April 2015|
|End date||September 2017|
|Trial size||48 participants|
|Trial identifier||NCT02427724, STU200401|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
visual analog score (VAS) pain rating
time frame: Day of treatment
Female participants from 25 years up to 65 years old.
Inclusion Criteria: 1. Patients who have moderate lentigines and/or photodamage and desire laser toning. 2. Females 25-65 years of age. 3. In good health. 4. Have Fitzpatrick phototype I-III. 5. Willingness and the ability to understand and provide informed consent and communicate with the investigator/study staff. Exclusion Criteria: 1. Younger than 25 or older than 65 years of age. 2. Pregnant or lactating. 3. Is a male. 4. 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 5. Has an active infection on the face or upper inner arms (excluding mild acne). 6. Is allergic to lidocaine, tetracaine, or prilocaine. 7. Has kidney disease and/or liver disease. 8. Has G-6-PD and/or pseudocholinesterase deficiency. 9. Is taking a class I anti-arrhythmic medication. 10. Is tanned. 11. Has a history of hyperpigmentation with laser treatment. 12. Has a mental illness. 13. Has a history of a chronic pain condition such as fibromyalgia or vulvodynia. 14. Unable to understand the protocol or to give informed consent. 15. Multiply recurrent episodes of cold sores. 16. Any significant skin disease beyond mild acne. 17. 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.
|Official title||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|
|Principal investigator||Murad Alam, MD|
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