The Effect of Topical Anesthetics on Patients' Pain and Operative Experience During Treatment With QSwitched Laser
Lentigo
About this trial
This is an interventional other trial for Lentigo
Eligibility Criteria
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.
Sites / Locations
- Northwestern University Feinberg School of Medicine, Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
lidocaine 2.5%/prilocaine 2.5% topical anesthetic
lidocaine 7%/tetracaine 7% topical anesthetic
placebo vehicle
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.
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.
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.