The Effect of Topical Anesthetics on Patients' Pain and Operative Experience During Treatment With QSwitched Laser
NCT ID: NCT02427724
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
EARLY_PHASE1
48 participants
INTERVENTIONAL
2015-04-30
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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lidocaine 2.5%/prilocaine 2.5% topical anesthetic
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.
lidocaine 2.5%/prilocaine 2.5% topical anesthetic
Q-switched 532nm Laser
lidocaine 7%/tetracaine 7% topical anesthetic
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.
lidocaine 7%/tetracaine 7% topical anesthetic
Q-switched 532nm Laser
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.
placebo vehicle
Q-switched 532nm Laser
Interventions
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lidocaine 2.5%/prilocaine 2.5% topical anesthetic
lidocaine 7%/tetracaine 7% topical anesthetic
placebo vehicle
Q-switched 532nm Laser
Eligibility Criteria
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Inclusion Criteria
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
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.
25 Years
65 Years
FEMALE
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Murad Alam
Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Principal Investigators
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Murad Alam, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU200401
Identifier Type: -
Identifier Source: org_study_id
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