Overview

This trial is active, not recruiting.

Condition lentigo
Treatments lidocaine 2.5%/prilocaine 2.5% topical anesthetic, lidocaine 7%/tetracaine 7% topical anesthetic, placebo vehicle, q-switched 532nm laser
Sponsor Northwestern University
Start date April 2015
End date September 2016
Trial size 48 participants
Trial identifier NCT02427724, STU200401

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Arm
(Active Comparator)
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
(Active Comparator)
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 Comparator)
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

Primary Outcomes

Measure
visual analog score (VAS) pain rating
time frame: Day of treatment

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Northwestern University.