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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT02427724
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
lidocaine 2.5%/prilocaine 2.5% topical anesthetic	Q-switched 532nm Laser	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	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	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	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	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.

Primary Outcome Measures

Name	Time	Method
visual analog score (VAS) pain rating	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

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States