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

Lentigo Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02427724
• Other study ID #: STU200401
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lentigo

Intervention

Drug:
• lidocaine 2.5%/prilocaine 2.5% topical anesthetic

• lidocaine 7%/tetracaine 7% topical anesthetic

• placebo vehicle

Device:
• Q-switched 532nm Laser

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog score (VAS) pain rating	Subjects will fill out a visual analog score (VAS) pain rating after treatment with 0 being no pain and 10 being worst pain	Day of treatment