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
Overview
- Phase
- Early Phase 1
- Intervention
- lidocaine 2.5%/prilocaine 2.5% topical anesthetic
- Conditions
- Lentigo
- Sponsor
- Northwestern University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- visual analog score (VAS) pain rating
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Murad Alam
Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Northwestern University
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.
- •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.
Arms & Interventions
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.
Intervention: lidocaine 2.5%/prilocaine 2.5% topical anesthetic
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.
Intervention: 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.
Intervention: lidocaine 7%/tetracaine 7% topical anesthetic
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.
Intervention: 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.
Intervention: placebo vehicle
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.
Intervention: Q-switched 532nm Laser
Outcomes
Primary Outcomes
visual analog score (VAS) pain rating
Time Frame: Day of treatment
Subjects will fill out a visual analog score (VAS) pain rating after treatment with 0 being no pain and 10 being worst pain