Clinical trial NCT02427724: The Effect of Topical Anesthetics on Patients' Pain and Operative Experience During Treatment With QSwitched Laser
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Lentigo
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 48
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: visual analog score (VAS) pain rating
timeFrame: Day of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: