The Effect of Topical Anesthetics on Patients' Pain and Operative Experience During Treatment with QSwitched Laser

Northwestern University

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Lentigo

Treatments: Drug: lidocaine 2.5%/prilocaine 2.5% topical anesthetic; Drug: placebo vehicle; Device: Q-switched 532nm Laser; Drug: lidocaine 7%/tetracaine 7% topical anesthetic

Study type: Interventional

Funder types: Other

Identifiers

NCT02427724

STU200401

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

lidocaine 2.5%/prilocaine 2.5% topical anesthetic

Active Comparator group

Description:

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.

Treatment:

Device: Q-switched 532nm Laser

Drug: lidocaine 2.5%/prilocaine 2.5% topical anesthetic

lidocaine 7%/tetracaine 7% topical anesthetic

Active Comparator group

Description:

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.

Treatment:

Drug: lidocaine 7%/tetracaine 7% topical anesthetic

Device: Q-switched 532nm Laser

placebo vehicle

Placebo Comparator group

Description:

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.

Treatment:

Device: Q-switched 532nm Laser

Drug: placebo vehicle